A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors

A Randomized, Phase II, Multi-Center, Placebo-Controlled Study of Ipatasertib (GDC-0068), an Inhibitor of Akt, in Combination With Paclitaxel as Front-Line Treatment for Patients With Metastatic Triple-Negative Breast Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02162719

Acronym

LOTUS

Enrollment

124

Registered

2014-06-13

Start date

2014-08-19

Completion date

2019-08-31

Last updated

2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Brief summary

This multicenter, randomized, double-blind study will estimate the efficacy, safety and tolerability of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in participants with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and in participants with phosphatase and tensin homolog (PTEN)-low tumors.

Interventions

DRUGIpatasertib

Participants received ipatasertib orally 400 milligrams (mg) daily on Days 1-21 of each 28-day cycle.

DRUGPaclitaxel

Participants received paclitaxel 80 milligrams per square meter (mg/m\^2) intravenously (IV) on Days 1, 8, and 15 of each cycle.

DRUGPlacebo

Participants received oral placebo matched to ipatasertib, daily on Days 1-21 of each 28-day cycle.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically documented triple-negative adenocarcinoma of the breast that is inoperable locally advanced or metastatic and is not amenable to resection with curative intent * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen, required prior to randomization * Measurable disease, according to the RECIST v1.1 * Adequate hematologic and organ function within 14 days before the first study treatment * For female participants of childbearing potential, agreement (by both participant and partner) to use an effective form of contraception for the duration of the study and for 6 months after last dose of study treatment

Exclusion criteria

* Any previous therapy, including chemotherapy or hormonal or targeted therapy, for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast. Participants may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced triple negative adenocarcinoma, provided all treatments were completed greater than or equal to (\>/=) 6 months prior to Cycle 1 Day 1. Locally recurrent disease must not be amenable to resection with curative intent * Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1 * Known Human Epidermal Growth Factor Receptor 2 (HER2) positive, erythrocyte receptor (ER) positive, or progesterone receptor (PR) positive breast cancer * Previous therapy with Akt, PI3K, and/or mTOR inhibitors * Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study * Known presence of the brain or spinal cord metastasis, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments

Design outcomes

Primary

Measure	Time frame	Description
Progression Free Survival (PFS)	Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016)	PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (\<=30 days after the last dose of study treatment regimen) from any cause, whichever occurred first.
PFS in Participants With Phosphatase and Tensin Homolog (PTEN)-Low Tumors	Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016)	PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (\<=30 days after the last dose of study treatment regimen) from any cause, whichever occurred first.

Secondary

Measure	Time frame	Description
Overall Survival (OS)	Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 31 August 2019)	OS was defined as the time from the date of randomization to the date of death from any cause.
OS in Participants With PIK3CA/AKT1/PTEN-altered Tumors	Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 31 August 2019)	OS was defined as the time from the date of randomization to the date of death from any cause.
Objective Response Rate (ORR)	Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)	Confirmed tumor ORR in participants with measurable disease at baseline was assessed by the investigator per RECIST, v1.1. Confirmed ORR was defined as the percentage of participants who achieved either a complete response or partial response based on the investigator assessment that was confirmed by a repeat assessment no less than 4 weeks after the criteria for response was first met. Participants for whom no records of post-baseline tumor assessments were reported were counted as non-responders. Complete response (CR): disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
ORR in Participants With PTEN-Low Tumors	Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)	Confirmed tumor ORR in participants with measurable disease at baseline was assessed by the investigator per RECIST, v1.1. Confirmed ORR was defined as the percentage of participants who achieved either a complete response or partial response based on the investigator assessment that was confirmed by a repeat assessment no less than 4 weeks after the criteria for response was first met. Participants for whom no records of post-baseline tumor assessments were reported were counted as non-responders. Complete response (CR): disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
ORR in Participants With PIK3CA/AKT1/PTEN-altered Tumors	Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)	Confirmed tumor ORR in subjects with measurable disease at baseline was assessed by the investigator per RECIST, v1.1. Confirmed ORR was defined as the percentage of subjects who achieved either a complete response or partial response based on the investigator assessment that was confirmed by a repeat assessment no less than 4 weeks after the criteria for response was first met. Subjects for whom no records of post-baseline tumor assessments were reported were counted as non-responders. Complete response (CR): disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Duration of Response	Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)	Duration of objective response in subjects with measurable disease at baseline was defined as the time from first observation of an objective tumor response until first observation of disease progression, as assessed by the investigator per modified RECIST, v1.1.
Duration of Response in Participants With PTEN-Low Tumors	Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)	Duration of objective response in subjects with measurable disease at baseline was defined as the time from first observation of an objective tumor response until first observation of disease progression, as assessed by the investigator per modified RECIST, v1.1.
Duration of Response in Participants With PIK3CA/AKT1/PTEN-altered Tumors	Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)	Duration of objective response in participants with measurable disease at baseline was defined as the time from first observation of an objective tumor response until first observation of disease progression, as assessed by the investigator per modified RECIST, v1.1.
OS in Participants With PTEN-Low Tumors	Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 31 August 2019)	OS was defined as the time from the date of randomization to the date of death from any cause.
Time to Disease Progression in Participants With PTEN-Low Tumors	Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)	Time to disease progression was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1.
Time to Disease Progression in Participants With PIK3CA/AKT1/PTEN-altered Tumors	Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)	Time to disease progression was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1.
Safety: Percentage of Participants With Adverse Events	Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)	An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Pharmacokinetic Endpoint: Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 24 Hours (AUC0-24h) of Ipatasertib	Cycle 1 Day 1, Cycle 1 Day 8	PK parameters were not calculated due to sparse PK sampling.
Pharmacokinetic Endpoint: Apparent Clearance Following Oral Dosing (CL/F) of Ipatasertib	Cycle 1 Day 1, Cycle 1 Day 8	PK parameters were not calculated due to sparse PK sampling.
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Baseline (Cycle 1 Day 1) up to Cycle 5 Day 1	EORTC QLQ-C30 included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1=Not at all to 4=Very much; 2 questions used 7-point scale \[1=very poor to 7=Excellent\]). Scores averaged, transformed to 0-100 scale; a higher score=better level of functioning. For symptom scale scores, higher level=severe level of symptoms. A change of at least 10 points from baseline is considered clinically meaningful (Osoba D, Rodrigues G, Myles J, et al. Interpreting the significance of changes in health-related quality of life score. J Clin Oncol 1998;16:139-44). PRO measures were analyzed from baseline up to cycle 5. Scores from later timepoints were not analyzed due to attrition (in both arms, fewer than 50% of participants remained on treatment beyond cycle 5).
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Baseline (Cycle 1 Day 1) up to Cycle 5 Day 1	Subjects reporting \>/= 10-point increase compared to baseline (Cycle 1 Day 1) were considered improved, those reporting \<10-point difference were considered remained stable, and those reporting \>/=10-point decrease were considered worsened. A change of at least 10 points from baseline is considered clinically meaningful (Osoba D, Rodrigues G, Myles J, et al. Interpreting the significance of changes in health-related quality of life score. J Clin Oncol 1998;16:139-44). Patient reported outcome measures were analyzed from baseline up to and including cycle 5. Scores from later timepoints were not analyzed due to attrition (in both arms, fewer than 50% of participants remained on treatment beyond cycle 5).
Time to Disease Progression	Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)	Time to disease progression was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1.
PFS in Participants With Phosphatidylinositol-4,5-bisphosphate 3-kinase Catalytic Subunit Alpha (PIK3CA)/ Protein Kinase B (AKT1)/ PTEN-altered Tumors	Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016)	PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (\<=30 days after the last dose of study treatment regimen) from any cause, whichever occurred first.

Countries

Belgium, France, Italy, Singapore, South Korea, Spain, Taiwan, United States

Participant flow

Recruitment details

The study was conducted at 44 centers in 8 countries.

Pre-assignment details

A total of 166 participants were screened, out of which 42 participants failed screening. A total of 124 participants were enrolled at 44 sites. Results are reported here up to clinical cut-off date of 31st August 2019.

Participants by arm

Arm	Count
Ipatasertib and Paclitaxel Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	62
Placebo and Paclitaxel Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	62
Total	124

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	41	46
Overall Study	Discontinuation of Overall Survival Follow-up	10	10
Overall Study	Disease Progression	2	1
Overall Study	Lost to Follow-up	1	3
Overall Study	Withdrawal by Subject	8	2

Baseline characteristics

Characteristic	Placebo and Paclitaxel	Ipatasertib and Paclitaxel	Total
Age, Continuous	54.4 years STANDARD_DEVIATION 10.9	53.6 years STANDARD_DEVIATION 13.4	54.0 years STANDARD_DEVIATION 12.2
Race/Ethnicity, Customized Asian	30 Participants	28 Participants	58 Participants
Race/Ethnicity, Customized Black or African American	3 Participants	5 Participants	8 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants	2 Participants	5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	52 Participants	51 Participants	103 Participants
Race/Ethnicity, Customized Not Stated	5 Participants	5 Participants	10 Participants
Race/Ethnicity, Customized Other	1 Participants	3 Participants	4 Participants
Race/Ethnicity, Customized Unknown	2 Participants	4 Participants	6 Participants
Race/Ethnicity, Customized White	28 Participants	26 Participants	54 Participants
Sex: Female, Male Female	62 Participants	62 Participants	124 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	41 / 61	46 / 62
other Total, other adverse events	61 / 61	59 / 62
serious Total, serious adverse events	18 / 61	12 / 62

Outcome results

Primary

PFS in Participants With Phosphatase and Tensin Homolog (PTEN)-Low Tumors

PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (\<=30 days after the last dose of study treatment regimen) from any cause, whichever occurred first.

Time frame: Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016)

Population: The ITT population included all randomized participants allocated to the treatment arm to which they were randomized. Participants with PTEN-low tumors were evaluated for this endpoint.

Arm	Measure	Value (MEDIAN)	Dispersion
Ipatasertib and Paclitaxel	PFS in Participants With Phosphatase and Tensin Homolog (PTEN)-Low Tumors	6.18 Months	90% Confidence Interval 3.65
Placebo and Paclitaxel	PFS in Participants With Phosphatase and Tensin Homolog (PTEN)-Low Tumors	3.65 Months	90% Confidence Interval 2.53

p-value: 0.175390% CI: [0.3, 1.16]Log Rank

Primary

Progression Free Survival (PFS)

Time frame: Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016)

Population: The Intent to treat (ITT) population was defined as all randomized participants allocated to the treatment arm to which they were randomized.

Arm	Measure	Value (MEDIAN)	Dispersion
Ipatasertib and Paclitaxel	Progression Free Survival (PFS)	6.18 Months	90% Confidence Interval 4.57
Placebo and Paclitaxel	Progression Free Survival (PFS)	4.93 Months	90% Confidence Interval 3.58

p-value: 0.037290% CI: [0.4, 0.91]Log Rank

Secondary

Duration of Response

Duration of objective response in subjects with measurable disease at baseline was defined as the time from first observation of an objective tumor response until first observation of disease progression, as assessed by the investigator per modified RECIST, v1.1.

Time frame: Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)

Population: The ITT population was defined as all randomized participants allocated to the treatment arm to which they were randomized. Only participants who achieved a confirmed objective response were included in the analysis.

Arm	Measure	Value (MEDIAN)
Ipatasertib and Paclitaxel	Duration of Response	7.85 months
Placebo and Paclitaxel	Duration of Response	7.43 months

Secondary

Duration of Response in Participants With PIK3CA/AKT1/PTEN-altered Tumors

Duration of objective response in participants with measurable disease at baseline was defined as the time from first observation of an objective tumor response until first observation of disease progression, as assessed by the investigator per modified RECIST, v1.1.

Time frame: Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)

Population: ITT population included all randomized participants allocated to the treatment arm to which they were randomized. Participants with PIK3CA/AKT1/PTEN-altered tumors were evaluated for this endpoint. Only participants who achieved a confirmed objective response were included in the analysis.

Arm	Measure	Value (MEDIAN)
Ipatasertib and Paclitaxel	Duration of Response in Participants With PIK3CA/AKT1/PTEN-altered Tumors	11.24 Months
Placebo and Paclitaxel	Duration of Response in Participants With PIK3CA/AKT1/PTEN-altered Tumors	6.06 Months

Secondary

Duration of Response in Participants With PTEN-Low Tumors

Time frame: Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)

Population: ITT population included all randomized participants allocated to the treatment arm to which they were randomized. Participants with PTEN-low tumors were evaluated for this endpoint. Only participants who achieved a confirmed objective response were included in the analysis.

Arm	Measure	Value (MEDIAN)
Ipatasertib and Paclitaxel	Duration of Response in Participants With PTEN-Low Tumors	6.54 Months
Placebo and Paclitaxel	Duration of Response in Participants With PTEN-Low Tumors	7.49 Months

Secondary

Objective Response Rate (ORR)

Confirmed tumor ORR in participants with measurable disease at baseline was assessed by the investigator per RECIST, v1.1. Confirmed ORR was defined as the percentage of participants who achieved either a complete response or partial response based on the investigator assessment that was confirmed by a repeat assessment no less than 4 weeks after the criteria for response was first met. Participants for whom no records of post-baseline tumor assessments were reported were counted as non-responders. Complete response (CR): disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

Time frame: Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)

Population: The Intent to treat (ITT) population was defined as all randomized participants allocated to the treatment arm to which they were randomized.

Arm	Measure	Value (NUMBER)	Dispersion
Ipatasertib and Paclitaxel	Objective Response Rate (ORR)	40.3 Percentage of Participants	90% Confidence Interval 30.64
Placebo and Paclitaxel	Objective Response Rate (ORR)	32.3 Percentage of Participants	90% Confidence Interval 23.35

Secondary

ORR in Participants With PIK3CA/AKT1/PTEN-altered Tumors

Confirmed tumor ORR in subjects with measurable disease at baseline was assessed by the investigator per RECIST, v1.1. Confirmed ORR was defined as the percentage of subjects who achieved either a complete response or partial response based on the investigator assessment that was confirmed by a repeat assessment no less than 4 weeks after the criteria for response was first met. Subjects for whom no records of post-baseline tumor assessments were reported were counted as non-responders. Complete response (CR): disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

Time frame: Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)

Population: The ITT population was defined as all randomized participants allocated to the treatment arm to which they were randomized. Participants with PIK3CA/AKT1/PTEN-altered tumors were evaluated for this endpoint.

Arm	Measure	Value (NUMBER)	Dispersion
Ipatasertib and Paclitaxel	ORR in Participants With PIK3CA/AKT1/PTEN-altered Tumors	50.0 Percentage of Participants	90% Confidence Interval 34.24
Placebo and Paclitaxel	ORR in Participants With PIK3CA/AKT1/PTEN-altered Tumors	43.8 Percentage of Participants	90% Confidence Interval 23.53

Secondary

ORR in Participants With PTEN-Low Tumors

Time frame: Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)

Population: The ITT population was defined as all randomized participants allocated to the treatment arm to which they were randomized. Participants with PTEN-Low Tumors were evaluated for this endpoint.

Arm	Measure	Value (NUMBER)	Dispersion
Ipatasertib and Paclitaxel	ORR in Participants With PTEN-Low Tumors	48.0 Percentage of Participants	90% Confidence Interval 30.73
Placebo and Paclitaxel	ORR in Participants With PTEN-Low Tumors	26.1 Percentage of Participants	90% Confidence Interval 12.02

Secondary

OS in Participants With PIK3CA/AKT1/PTEN-altered Tumors

OS was defined as the time from the date of randomization to the date of death from any cause.

Time frame: Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 31 August 2019)

Arm	Measure	Value (MEDIAN)	Dispersion
Ipatasertib and Paclitaxel	OS in Participants With PIK3CA/AKT1/PTEN-altered Tumors	25.8 months	95% Confidence Interval 18.6
Placebo and Paclitaxel	OS in Participants With PIK3CA/AKT1/PTEN-altered Tumors	22.1 months	95% Confidence Interval 8.7

p-value: 0.759995% CI: [0.52, 2.47]Log Rank

Secondary

OS in Participants With PTEN-Low Tumors

OS was defined as the time from the date of randomization to the date of death from any cause.

Time frame: Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 31 August 2019)

Population: The ITT population was defined as all randomized participants allocated to the treatment arm to which they were randomized. Participants with PTEN-low tumors were evaluated for this endpoint.

Arm	Measure	Value (MEDIAN)	Dispersion
Ipatasertib and Paclitaxel	OS in Participants With PTEN-Low Tumors	23.1 months	95% Confidence Interval 18.3
Placebo and Paclitaxel	OS in Participants With PTEN-Low Tumors	15.8 months	95% Confidence Interval 9

p-value: 0.442295% CI: [0.32, 1.65]Log Rank

Secondary

Overall Survival (OS)

OS was defined as the time from the date of randomization to the date of death from any cause.

Time frame: Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 31 August 2019)

Population: The ITT population was defined as all randomized participants allocated to the treatment arm to which they were randomized.

Arm	Measure	Value (MEDIAN)	Dispersion
Ipatasertib and Paclitaxel	Overall Survival (OS)	25.8 months	95% Confidence Interval 18.6
Placebo and Paclitaxel	Overall Survival (OS)	16.9 months	95% Confidence Interval 14.6

p-value: 0.360795% CI: [0.5, 1.28]Log Rank

Secondary

Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score

EORTC QLQ-C30 included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1=Not at all to 4=Very much; 2 questions used 7-point scale \[1=very poor to 7=Excellent\]). Scores averaged, transformed to 0-100 scale; a higher score=better level of functioning. For symptom scale scores, higher level=severe level of symptoms. A change of at least 10 points from baseline is considered clinically meaningful (Osoba D, Rodrigues G, Myles J, et al. Interpreting the significance of changes in health-related quality of life score. J Clin Oncol 1998;16:139-44). PRO measures were analyzed from baseline up to cycle 5. Scores from later timepoints were not analyzed due to attrition (in both arms, fewer than 50% of participants remained on treatment beyond cycle 5).

Time frame: Baseline (Cycle 1 Day 1) up to Cycle 5 Day 1

Population: The PRO Analysis population was defined as the ITT population with a baseline and at least one post baseline PRO assessment. Data presented below is only for participants included in the actual analysis.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Financial difficulties Cycle 4 Day 1	3.40 unit on a scale	Standard Deviation 23.81
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Constipation: Cycle 2 Day 1	5.85 unit on a scale	Standard Deviation 24.5
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Financial difficulties Cycle 5 Day 1	2.78 unit on a scale	Standard Deviation 25.67
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Dyspnea: Cycle 2 Day 1	2.92 unit on a scale	Standard Deviation 19.19
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Nausea/Vomiting Cycle 2 Day 1	9.06 unit on a scale	Standard Deviation 19.43
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Appetite loss:Cycle 3	9.42 unit on a scale	Standard Deviation 21.84
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Nausea/Vomiting Cycle 3 Day 1	6.52 unit on a scale	Standard Deviation 14.26
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Dyspnea: Cycle 3 Day 1	5.07 unit on a scale	Standard Deviation 23.27
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Nausea/Vomiting Cycle 4 Day 1	6.80 unit on a scale	Standard Deviation 17.32
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Constipation: Cycle 3 Day 1	2.90 unit on a scale	Standard Deviation 19.66
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Nausea/Vomiting Cycle 5 Day 1	3.70 unit on a scale	Standard Deviation 7.03
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Dyspnea: Cycle 4 Day 1	3.40 unit on a scale	Standard Deviation 25.68
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Pain Cycle 2 Day 1	-3.80 unit on a scale	Standard Deviation 22.93
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Cognitive Functioning: Cycle 3 Day 1	-1.81 unit on a scale	Standard Deviation 19.64
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Pain Cycle 3 Day 1	-4.71 unit on a scale	Standard Deviation 26.45
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Dyspnea: Cycle 5 Day 1	5.56 unit on a scale	Standard Deviation 25.82
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Pain Cycle 4 Day 1	1.36 unit on a scale	Standard Deviation 28.63
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Constipation: Cycle 4 Day 1	1.39 unit on a scale	Standard Deviation 16.78
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Pain Cycle 5 Day 1	0.00 unit on a scale	Standard Deviation 26.13
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Emotional Functioning: Cycle 2 Day 1	12.09 unit on a scale	Standard Deviation 15.9
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Physical Functioning Cycle 2 Day 1	-4.53 unit on a scale	Standard Deviation 14.23
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Appetite loss:Cycle 5	0.00 unit on a scale	Standard Deviation 18.08
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Physical Functioning Cycle 3 Day 1	-5.94 unit on a scale	Standard Deviation 15.54
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Emotional Functioning: Cycle 3 Day 1	7.37 unit on a scale	Standard Deviation 17.18
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Physical Functioning Cycle 4 Day 1	-9.12 unit on a scale	Standard Deviation 13.92
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Constipation: Cycle 5 Day 1	2.78 unit on a scale	Standard Deviation 14.64
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Physical Functioning Cycle 5 Day 1	-8.56 unit on a scale	Standard Deviation 13.47
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Emotional Functioning: Cycle 4 Day 1	8.22 unit on a scale	Standard Deviation 16.53
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Global health status Cycle 2 Day 1	-4.68 unit on a scale	Standard Deviation 22.33
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Cognitive Functioning: Cycle 4 Day 1	-3.40 unit on a scale	Standard Deviation 15.95
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Global health status Cycle 3 Day 1	-8.15 unit on a scale	Standard Deviation 21.55
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Emotional Functioning: Cycle 5 Day 1	8.73 unit on a scale	Standard Deviation 16.3
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Global health status Cycle 4 Day 1	-8.50 unit on a scale	Standard Deviation 21.62
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Diarrhoea: Cycle 2 Day 1	17.54 unit on a scale	Standard Deviation 30.28
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Global health status Cycle 5 Day 1	-6.48 unit on a scale	Standard Deviation 22.55
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Fatigue: Cycle 2 Day 1	7.99 unit on a scale	Standard Deviation 22.69
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Role Functioning Cycle 2 Day 1	-5.85 unit on a scale	Standard Deviation 20.04
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Appetite loss:Cycle 4	5.44 unit on a scale	Standard Deviation 23.91
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Role Functioning Cycle 3 Day 1	-10.51 unit on a scale	Standard Deviation 24.43
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Fatigue: Cycle 3 Day 1	9.18 unit on a scale	Standard Deviation 22.63
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Role Functioning Cycle 4 Day 1	-13.95 unit on a scale	Standard Deviation 25.76
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Diarrhoea: Cycle 3 Day 1	23.91 unit on a scale	Standard Deviation 34.9
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Role Functioning Cycle 5 Day 1	-11.57 unit on a scale	Standard Deviation 21.76
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Fatigue: Cycle 4 Day 1	7.94 unit on a scale	Standard Deviation 20.91
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Social Functioning Cycle 2 Day 1	-2.05 unit on a scale	Standard Deviation 26.92
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Cognitive Functioning: Cycle 5 Day 1	0.00 unit on a scale	Standard Deviation 13.8
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Social Functioning Cycle 3 Day 1	-2.17 unit on a scale	Standard Deviation 23.99
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Fatigue: Cycle 5 Day 1	10.32 unit on a scale	Standard Deviation 20.35
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Social Functioning Cycle 4 Day 1	-7.14 unit on a scale	Standard Deviation 27
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Diarrhoea: Cycle 4 Day 1	19.73 unit on a scale	Standard Deviation 34.64
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Social Functioning Cycle 5 Day 1	-4.76 unit on a scale	Standard Deviation 31.72
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Financial difficulties Cycle 2 Day 1	3.57 unit on a scale	Standard Deviation 21.72
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Insomnia Cycle 2 Day 1	2.92 unit on a scale	Standard Deviation 31.67
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Cognitive Functioning: Cycle 2 Day 1	1.17 unit on a scale	Standard Deviation 14.04
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Insomnia Cycle 3 Day 1	2.90 unit on a scale	Standard Deviation 25.17
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Financial difficulties Cycle 3 Day 1	0.72 unit on a scale	Standard Deviation 22.76
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Insomnia Cycle 4 Day 1	7.48 unit on a scale	Standard Deviation 28.27
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Diarrhoea: Cycle 5 Day 1	21.90 unit on a scale	Standard Deviation 37.87
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Insomnia Cycle 5 Day 1	1.85 unit on a scale	Standard Deviation 34.68
Ipatasertib and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Appetite loss:Cycle 2	7.60 unit on a scale	Standard Deviation 28.18
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Insomnia Cycle 5 Day 1	-5.56 unit on a scale	Standard Deviation 29.14
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Appetite loss:Cycle 2	-0.63 unit on a scale	Standard Deviation 24.88
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Appetite loss:Cycle 3	-3.88 unit on a scale	Standard Deviation 24.35
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Appetite loss:Cycle 4	-4.17 unit on a scale	Standard Deviation 25.25
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Appetite loss:Cycle 5	-1.11 unit on a scale	Standard Deviation 25.5
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Cognitive Functioning: Cycle 2 Day 1	0.63 unit on a scale	Standard Deviation 17.28
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Cognitive Functioning: Cycle 3 Day 1	-1.81 unit on a scale	Standard Deviation 19.64
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Cognitive Functioning: Cycle 4 Day 1	0.00 unit on a scale	Standard Deviation 20.32
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Cognitive Functioning: Cycle 5 Day 1	-4.44 unit on a scale	Standard Deviation 19.54
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Constipation: Cycle 2 Day 1	0.63 unit on a scale	Standard Deviation 25.73
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Constipation: Cycle 3 Day 1	1.59 unit on a scale	Standard Deviation 22.03
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Constipation: Cycle 4 Day 1	0.83 unit on a scale	Standard Deviation 30.65
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Constipation: Cycle 5 Day 1	1.11 unit on a scale	Standard Deviation 20.5
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Diarrhoea: Cycle 2 Day 1	1.89 unit on a scale	Standard Deviation 15.21
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Diarrhoea: Cycle 3 Day 1	3.88 unit on a scale	Standard Deviation 18.13
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Diarrhoea: Cycle 4 Day 1	0.83 unit on a scale	Standard Deviation 15.99
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Diarrhoea: Cycle 5 Day 1	1.11 unit on a scale	Standard Deviation 16.34
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Dyspnea: Cycle 2 Day 1	0.00 unit on a scale	Standard Deviation 18.67
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Dyspnea: Cycle 3 Day 1	2.44 unit on a scale	Standard Deviation 22.84
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Dyspnea: Cycle 4 Day 1	5.13 unit on a scale	Standard Deviation 22.35
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Dyspnea: Cycle 5 Day 1	4.76 unit on a scale	Standard Deviation 23.51
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Emotional Functioning: Cycle 2 Day 1	4.72 unit on a scale	Standard Deviation 16.87
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Emotional Functioning: Cycle 3 Day 1	3.88 unit on a scale	Standard Deviation 20.36
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Emotional Functioning: Cycle 4 Day 1	2.71 unit on a scale	Standard Deviation 21.47
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Emotional Functioning: Cycle 5 Day 1	1.39 unit on a scale	Standard Deviation 17.79
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Fatigue: Cycle 2 Day 1	-1.36 unit on a scale	Standard Deviation 16.98
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Fatigue: Cycle 3 Day 1	1.42 unit on a scale	Standard Deviation 19.44
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Fatigue: Cycle 4 Day 1	1.85 unit on a scale	Standard Deviation 21.64
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Fatigue: Cycle 5 Day 1	1.67 unit on a scale	Standard Deviation 20.59
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Financial difficulties Cycle 2 Day 1	0.00 unit on a scale	Standard Deviation 20.87
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Financial difficulties Cycle 3 Day 1	-3.88 unit on a scale	Standard Deviation 24.35
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Financial difficulties Cycle 4 Day 1	-0.83 unit on a scale	Standard Deviation 29.71
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Financial difficulties Cycle 5 Day 1	1.11 unit on a scale	Standard Deviation 26.96
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Nausea/Vomiting Cycle 2 Day 1	2.83 unit on a scale	Standard Deviation 15.24
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Nausea/Vomiting Cycle 3 Day 1	3.10 unit on a scale	Standard Deviation 14.21
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Nausea/Vomiting Cycle 4 Day 1	3.75 unit on a scale	Standard Deviation 17.5
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Nausea/Vomiting Cycle 5 Day 1	0.00 unit on a scale	Standard Deviation 23.16
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Pain Cycle 2 Day 1	-7.86 unit on a scale	Standard Deviation 23.02
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Pain Cycle 3 Day 1	-7.36 unit on a scale	Standard Deviation 26.8
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Pain Cycle 4 Day 1	-3.33 unit on a scale	Standard Deviation 31.62
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Pain Cycle 5 Day 1	-5.56 unit on a scale	Standard Deviation 25.27
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Physical Functioning Cycle 2 Day 1	-0.16 unit on a scale	Standard Deviation 12.96
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Physical Functioning Cycle 3 Day 1	-1.71 unit on a scale	Standard Deviation 13.88
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Physical Functioning Cycle 4 Day 1	-3.17 unit on a scale	Standard Deviation 16.54
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Physical Functioning Cycle 5 Day 1	-4.44 unit on a scale	Standard Deviation 14.26
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Global health status Cycle 2 Day 1	4.72 unit on a scale	Standard Deviation 18.38
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Global health status Cycle 3 Day 1	3.29 unit on a scale	Standard Deviation 21.37
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Global health status Cycle 4 Day 1	-1.46 unit on a scale	Standard Deviation 26.61
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Global health status Cycle 5 Day 1	-5.00 unit on a scale	Standard Deviation 21.62
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Role Functioning Cycle 2 Day 1	0.63 unit on a scale	Standard Deviation 22.4
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Role Functioning Cycle 3 Day 1	-2.71 unit on a scale	Standard Deviation 22.69
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Role Functioning Cycle 4 Day 1	-6.25 unit on a scale	Standard Deviation 26.34
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Role Functioning Cycle 5 Day 1	-7.22 unit on a scale	Standard Deviation 21.3
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Social Functioning Cycle 2 Day 1	0.00 unit on a scale	Standard Deviation 23.34
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Social Functioning Cycle 3 Day 1	-3.49 unit on a scale	Standard Deviation 26.11
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Social Functioning Cycle 4 Day 1	-5.83 unit on a scale	Standard Deviation 23.74
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Social Functioning Cycle 5 Day 1	-9.44 unit on a scale	Standard Deviation 24.24
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Insomnia Cycle 2 Day 1	-5.03 unit on a scale	Standard Deviation 24.8
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Insomnia Cycle 3 Day 1	-3.10 unit on a scale	Standard Deviation 25
Placebo and Paclitaxel	Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score	Insomnia Cycle 4 Day 1	5.83 unit on a scale	Standard Deviation 31.02

Secondary

PFS in Participants With Phosphatidylinositol-4,5-bisphosphate 3-kinase Catalytic Subunit Alpha (PIK3CA)/ Protein Kinase B (AKT1)/ PTEN-altered Tumors

Time frame: Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016)

Arm	Measure	Value (MEDIAN)	Dispersion
Ipatasertib and Paclitaxel	PFS in Participants With Phosphatidylinositol-4,5-bisphosphate 3-kinase Catalytic Subunit Alpha (PIK3CA)/ Protein Kinase B (AKT1)/ PTEN-altered Tumors	9.03 Months	90% Confidence Interval 4.57
Placebo and Paclitaxel	PFS in Participants With Phosphatidylinositol-4,5-bisphosphate 3-kinase Catalytic Subunit Alpha (PIK3CA)/ Protein Kinase B (AKT1)/ PTEN-altered Tumors	4.93 Months	90% Confidence Interval 3.58

p-value: 0.363690% CI: [0.46, 1.27]Log Rank

Secondary

Pharmacokinetic Endpoint: Apparent Clearance Following Oral Dosing (CL/F) of Ipatasertib

PK parameters were not calculated due to sparse PK sampling.

Time frame: Cycle 1 Day 1, Cycle 1 Day 8

Population: The PK Analysis population was defined as all participants who had evaluable PK data.

Arm	Measure	Value (NUMBER)
Ipatasertib and Paclitaxel	Pharmacokinetic Endpoint: Apparent Clearance Following Oral Dosing (CL/F) of Ipatasertib	NA ml/hr

Secondary

Pharmacokinetic Endpoint: Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 24 Hours (AUC0-24h) of Ipatasertib

PK parameters were not calculated due to sparse PK sampling.

Time frame: Cycle 1 Day 1, Cycle 1 Day 8

Population: The PK Analysis population was defined as all participants who had evaluable PK data.

Arm	Measure	Value (NUMBER)
Ipatasertib and Paclitaxel	Pharmacokinetic Endpoint: Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 24 Hours (AUC0-24h) of Ipatasertib	NA h*ng/mL/mg

Secondary

PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30

Subjects reporting \>/= 10-point increase compared to baseline (Cycle 1 Day 1) were considered improved, those reporting \<10-point difference were considered remained stable, and those reporting \>/=10-point decrease were considered worsened. A change of at least 10 points from baseline is considered clinically meaningful (Osoba D, Rodrigues G, Myles J, et al. Interpreting the significance of changes in health-related quality of life score. J Clin Oncol 1998;16:139-44). Patient reported outcome measures were analyzed from baseline up to and including cycle 5. Scores from later timepoints were not analyzed due to attrition (in both arms, fewer than 50% of participants remained on treatment beyond cycle 5).

Time frame: Baseline (Cycle 1 Day 1) up to Cycle 5 Day 1

Arm	Measure	Group	Value (NUMBER)
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Nausea/Vomiting Cycle 4	2.0 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Appetite Loss: Cycle 2	64.9 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Appetite Loss: Cycle 2	24.6 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Appetite Loss: Cycle 3	8.7 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Appetite Loss: Cycle 3	56.5 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Appetite Loss: Cycle 3	34.8 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Appetite Loss: Cycle 4	10.2 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Appetite Loss: Cycle 4	65.3 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Appetite Loss: Cycle 4	24.5 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Appetite Loss: Cycle 5	8.6 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Appetite Loss: Cycle 5	80.0 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Appetite Loss: Cycle 5	11.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Diarrhea: Cycle 2	3.5 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Diarrhea: Cycle 2	50.9 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Diarrhea: Cycle 2	45.6 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Diarrhea: Cycle 3	8.7 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Diarrhea: Cycle 3	39.1 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Diarrhea: Cycle 3	52.2 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Diarrhea: Cycle 4	10.2 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Diarrhea: Cycle 4	38.8 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Diarrhea: Cycle 4	51.0 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Diarrhea: Cycle 5	14.3 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Diarrhea: Cycle 5	34.3 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Diarrhea: Cycle 5	51.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Fatigue: Cycle 2	21.1 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Fatigue: Cycle 2	29.85 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Fatigue: Cycle 2	49.1 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Fatigue: Cycle 3	23.9 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Fatigue: Cycle 3	15.2 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Fatigue: Cycle 3	60.9 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Fatigue: Cycle 4	24.5 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Fatigue: Cycle 4	28.6 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Fatigue: Cycle 4	46.9 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Fatigue: Cycle 5	20.0 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Fatigue: Cycle 5	20.0 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Fatigue: Cycle 5	60.0 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Nausea/Vomiting Cycle 2	3.5 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Nausea/Vomiting Cycle 2	61.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Nausea/Vomiting Cycle 2	35.1 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Nausea/Vomiting Cycle 3	4.3 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Nausea/Vomiting Cycle 3	65.2 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Nausea/Vomiting Cycle 3	30.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Appetite Loss: Cycle 2	10.5 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Nausea/Vomiting Cycle 4	73.5 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Nausea/Vomiting Cycle 4	24.5 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Nausea/Vomiting Cycle 5	0 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Nausea/Vomiting Cycle 5	77.8 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Nausea/Vomiting Cycle 5	22.2 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Cognitive Functioning Cycle 2	22.8 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Cognitive Function Cycle 2	61.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Cognitive Function Cycle 2	15.8 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Cognitive Functioning Cycle 3	26.1 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Cognitive Functioning Cycle 3	47.8 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Cognitive Functioning Cycle 3	26.1 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Cognitive Functioning Cycle 4	20.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Cognitive Functioning Cycle 4	51.0 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Cognitive Functioning Cycle 4	28.6 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Cognitive Functioning Cycle 5	19.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Cognitive Functioning Cycle 5	58.3 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Cognitive Functioning Cycle 5	22.2 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Constipation Cycle 2	8.8 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Constipation Cycle 2	73.7 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Constipation Cycle 2	17.5 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Constipation Cycle 3	10.9 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Constipation Cycle 3	71.7 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Constipation Cycle 3	17.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Constipation Cycle 4	10.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Constipation Cycle 4	75.0 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Constipation Cycle 4	14.6 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Constipation Cycle 5	5.6 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Constipation Cycle 5	80.6 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Constipation Cycle 5	13.9 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Dyspnea Cycle 2	5.3 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Dyspnea Cycle 2	77.2 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Dyspnea Cycle 2	17.5 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Dyspnea Cycle 3	6.5 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Dyspnea Cycle 3	67.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Dyspnea Cycle 3	26.1 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Dyspnea Cycle 4	10.2 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Dyspnea Cycle 4	69.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Dyspnea Cycle 4	20.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Dyspnea Cycle 5	8.3 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Dyspnea Cycle 5	69.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Dyspnea Cycle 5	22.2 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Emotional Functioning Cycle 2	50.9 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Emotional Functioning Cycle 2	43.9 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Emotional Functioning Cycle 2	5.3 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Emotional Functioning Cycle 3	45.7 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Emotional Functioning Cycle 3	45.7 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Emotional Functioning Cycle 3	8.7 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Emotional Functioning Cycle 4	42.9 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Emotional Functioning Cycle 4	49.0 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Emotional Functioning Cycle 4	8.2 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Emotional Functioning Cycle 5	42.9 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Emotional Functioning Cycle 5	48.6 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Emotional Functioning Cycle 5	8.6 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Financial Difficulties Cycle 2	10.7 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Financial Difficulties Cycle 2	73.2 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Financial Difficulties Cycle 2	16.1 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Financial Difficulties Cycle 3	13.0 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Financial Difficulties Cycle 3	73.9 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Financial Difficulties Cycle 3	13.0 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Financial Difficulties Cycle 4	10.2 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Financial Difficulties Cycle 4	73.5 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Financial Difficulties Cycle 4	16.3 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Financial Difficulties Cycle 5	13.9 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Financial Difficulties Cycle 5	66.7 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Financial Difficulties Cycle 5	19.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Pain Cycle 2	35.1 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Pain Cycle 2	40.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Pain Cycle 2	24.6 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Pain Cycle 3	37.0 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Pain Cycle 3	39.1 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Pain Cycle	23.9 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Pain Cycle 4	32.7 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Pain Cycle 4	32.7 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Pain Cycle 4	34.7 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Pain Cycle 5	33.3 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Pain Cycle 5	30.6 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Pain Cycle 5	36.1 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Physical Functioning Cycle 2	7.0 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Physical Functioning Cycle 2	68.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Physical Functioning Cycle 2	24.6 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Physical Functioning Cycle 3	8.7 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Physical Functioning Cycle 3	67.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Physical Functioning Cycle 3	23.9 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Physical Functioning Cycle 4	4.1 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Physical Functioning Cycle 4	55.1 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Physical Functioning Cycle 4	40.8 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Physical Functioning Cycle 5	8.3 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Physical Functioning Cycle 5	44.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Physical Functioning Cycle 5	47.2 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Global Health Status/QoL Cycle 2	19.3 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Global Health Status/QoL Cycle 2	45.6 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Global Health Status/QoL Cycle 2	35.1 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Global Health Status/QoL Cycle 3	17.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Global Health Status/QoL Cycle 3	37.0 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Global Health Status/QoL Cycle 3	45.7 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Global Health Status/QoL Cycle 4	14.3 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Global Health Status/QoL Cycle 4	51.0 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Global Health Status/QoL Cycle 4	34.7 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Global Health Status/QoL Cycle 5	11.1 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Global Health Status/QoL Cycle 5	58.3 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Global Health Status/QoL Cycle 5	30.6 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Role Functioning Cycle 2	17.5 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Role Functioning Cycle 2	52.6 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Role Functioning Cycle 2	29.8 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Role Functioning Cycle 3	13.0 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Role Functioning Cycle 3	47.8 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Role Functioning Cycle 3	39.1 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Role Functioning Cycle 4	12.2 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Role Functioning Cycle 4	38.8 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Role Functioning Cycle 4	49.0 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Role Functioning Cycle 5	11.1 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Role Functioning Cycle 5	47.2 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Role Functioning Cycle 5	41.7 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Social Functioning Cycle 2	21.1 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Social Functioning Cycle 2	49.1 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Social Functioning Cycle 2	29.8 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Social Functioning Cycle 3	17.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Social Functioning Cycle 3	52.2 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Social Functioning Cycle 3	30.4 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Social Functioning Cycle 4	16.3 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Social Functioning Cycle 4	49.0 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Social Functioning Cycle 4	34.7 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Social Functioning Cycle 5	17.1 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Social Functioning Cycle 5	48.6 Percentage of Participants
Ipatasertib and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Social Functioning Cycle 5	34.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Social Functioning Cycle 2	49.1 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Appetite Loss: Cycle 2	18.9 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Emotional Functioning Cycle 2	35.8 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Appetite Loss: Cycle 2	66.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Physical Functioning Cycle 4	17.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Appetite Loss: Cycle 2	15.1 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Emotional Functioning Cycle 2	50.9 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Appetite Loss: Cycle 3	27.9 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Role Functioning Cycle 3	27.9 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Appetite Loss: Cycle 3	53.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Emotional Functioning Cycle 2	13.2 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Appetite Loss: Cycle 3	18.6 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Physical Functioning Cycle 4	57.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Appetite Loss: Cycle 4	30.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Emotional Functioning Cycle 3	37.2 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Appetite Loss: Cycle 4	57.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Social Functioning Cycle 5	13.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Appetite Loss: Cycle 4	12.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Emotional Functioning Cycle 3	41.9 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Appetite Loss: Cycle 5	26.7 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Physical Functioning Cycle 4	25.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Appetite Loss: Cycle 5	53.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Emotional Functioning Cycle 3	20.9 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Appetite Loss: Cycle 5	20.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Role Functioning Cycle 3	46.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Diarrhea: Cycle 2	7.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Emotional Functioning Cycle 4	30.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Diarrhea: Cycle 2	79.2 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Physical Functioning Cycle 5	16.7 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Diarrhea: Cycle 2	13.2 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Emotional Functioning Cycle 4	45.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Diarrhea: Cycle 3	9.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Social Functioning Cycle 2	28.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Diarrhea: Cycle 3	69.8 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Emotional Functioning Cycle 4	25.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Diarrhea: Cycle 3	20.9 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Physical Functioning Cycle 5	46.7 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Diarrhea: Cycle 4	10.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Emotional Functioning Cycle 5	36.7 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Diarrhea: Cycle 4	77.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Role Functioning Cycle 3	25.6 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Diarrhea: Cycle 4	12.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Emotional Functioning Cycle 5	36.7 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Diarrhea: Cycle 5	10.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Physical Functioning Cycle 5	36.7 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Diarrhea: Cycle 5	76.7 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Emotional Functioning Cycle 5	26.7 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Diarrhea: Cycle 5	13.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Social Functioning Cycle 4	47.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Fatigue: Cycle 2	34.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Financial Difficulties Cycle 2	13.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Fatigue: Cycle 2	30.2 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Global Health Status/QoL Cycle 2	26.4 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Fatigue: Cycle 2	35.8 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Financial Difficulties Cycle 2	73.1 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Fatigue: Cycle 3	34.9 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Role Functioning Cycle 4	25.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Fatigue: Cycle 3	30.2 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Financial Difficulties Cycle 2	13.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Fatigue: Cycle 3	34.9 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Global Health Status/QoL Cycle 2	58.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Fatigue: Cycle 4	28.2 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Financial Difficulties Cycle 3	18.6 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Fatigue: Cycle 4	28.2 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Social Functioning Cycle 3	16.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Fatigue: Cycle 4	43.6 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Financial Difficulties Cycle 3	72.1 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Fatigue: Cycle 5	30.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Global Health Status/QoL Cycle 2	15.1 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Fatigue: Cycle 5	43.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Financial Difficulties Cycle 3	9.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Fatigue: Cycle 5	26.7 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Role Functioning Cycle 4	37.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Nausea/Vomiting Cycle 2	11.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Financial Difficulties Cycle 4	17.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Nausea/Vomiting Cycle 2	64.2 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Global Health Status/QoL Cycle 3	25.6 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Nausea/Vomiting Cycle 2	24.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Financial Difficulties Cycle 4	70.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Nausea/Vomiting Cycle 3	9.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Social Functioning Cycle 5	50.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Nausea/Vomiting Cycle 3	62.8 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Financial Difficulties Cycle 4	12.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Nausea/Vomiting Cycle 3	27.9 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Global Health Status/QoL Cycle 3	60.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Nausea/Vomiting Cycle 4	7.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Financial Difficulties Cycle 5	20.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Nausea/Vomiting Cycle 4	67.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Role Functioning Cycle 4	37.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Nausea/Vomiting Cycle 4	25.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Financial Difficulties Cycle 5	63.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Nausea/Vomiting Cycle 5	16.7 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Global Health Status/QoL Cycle 3	14.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Nausea/Vomiting Cycle 5	60.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Financial Difficulties Cycle 5	16.7 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Nausea/Vomiting Cycle 5	23.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Social Functioning Cycle 3	53.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Cognitive Functioning Cycle 2	17.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Pain Cycle 2	35.8 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Cognitive Function Cycle 2	60.4 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Global Health Status/QoL Cycle 4	25.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Cognitive Function Cycle 2	22.6 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Pain Cycle 2	45.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Cognitive Functioning Cycle 3	16.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Role Functioning Cycle 5	16.7 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Cognitive Functioning Cycle 3	53.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Pain Cycle 2	18.9 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Cognitive Functioning Cycle 3	30.2 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Global Health Status/QoL Cycle 4	42.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Cognitive Functioning Cycle 4	22.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Pain Cycle 3	39.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Cognitive Functioning Cycle 4	52.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Social Functioning Cycle 4	42.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Cognitive Functioning Cycle 4	25.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Pain Cycle 3	39.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Cognitive Functioning Cycle 5	20.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Global Health Status/QoL Cycle 4	32.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Cognitive Functioning Cycle 5	46.7 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Pain Cycle	20.9 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Cognitive Functioning Cycle 5	33.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Role Functioning Cycle 5	40.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Constipation Cycle 2	17.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Pain Cycle 4	37.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Constipation Cycle 2	64.2 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Global Health Status/QoL Cycle 5	20.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Constipation Cycle 2	18.9 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Pain Cycle 4	35.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Constipation Cycle 3	9.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Social Functioning Cycle 3	30.2 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Constipation Cycle 3	71.4 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Pain Cycle 4	27.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Constipation Cycle 3	19.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Global Health Status/QoL Cycle 5	46.7 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Constipation Cycle 4	15.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Pain Cycle 5	33.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Constipation Cycle 4	60.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Role Functioning Cycle 5	43.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Constipation Cycle 4	25.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Pain Cycle 5	40.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Constipation Cycle 5	13.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Global Health Status/QoL Cycle 5	33.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Constipation Cycle 5	73.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Pain Cycle 5	26.7 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Constipation Cycle 5	13.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Social Functioning Cycle 5	36.7 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Dyspnea Cycle 2	15.4 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Physical Functioning Cycle 2	13.2 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Dyspnea Cycle 2	69.2 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Role Functioning Cycle 2	24.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Dyspnea Cycle 2	15.4 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Physical Functioning Cycle 2	75.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Dyspnea Cycle 3	14.6 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Social Functioning Cycle 2	22.6 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Dyspnea Cycle 3	68.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Physical Functioning Cycle 2	11.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Dyspnea Cycle 3	17.1 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Role Functioning Cycle 2	45.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Dyspnea Cycle 4	12.8 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Physical Functioning Cycle 3	16.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Dyspnea Cycle 4	61.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Social Functioning Cycle 4	10.0 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Dyspnea Cycle 4	25.6 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Physical Functioning Cycle 3	60.5 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Improved Dyspnea Cycle 5	14.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Role Functioning Cycle 2	30.2 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Maintained Dyspnea Cycle 5	60.7 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Physical Functioning Cycle 3	23.3 Percentage of Participants
Placebo and Paclitaxel	PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30	Worsened Dyspnea Cycle 5	25.0 Percentage of Participants

Secondary

Safety: Percentage of Participants With Adverse Events

An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Time frame: Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)

Population: The Safety population included all treated participants with participants allocated to the treatment arm associated with the regimen that they actually received.

Arm	Measure	Value (NUMBER)
Ipatasertib and Paclitaxel	Safety: Percentage of Participants With Adverse Events	100.0 Percentage of Participants
Placebo and Paclitaxel	Safety: Percentage of Participants With Adverse Events	96.8 Percentage of Participants

Secondary

Time to Disease Progression

Time to disease progression was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1.

Time frame: Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)

Population: ITT population included all randomized participants allocated to the treatment arm to which they were randomized.

Arm	Measure	Value (MEDIAN)	Dispersion
Ipatasertib and Paclitaxel	Time to Disease Progression	6.18 Months	90% Confidence Interval 4.57
Placebo and Paclitaxel	Time to Disease Progression	4.96 Months	90% Confidence Interval 3.61

Secondary

Time to Disease Progression in Participants With PIK3CA/AKT1/PTEN-altered Tumors

Time to disease progression was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1.

Time frame: Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)

Arm	Measure	Value (MEDIAN)	Dispersion
Ipatasertib and Paclitaxel	Time to Disease Progression in Participants With PIK3CA/AKT1/PTEN-altered Tumors	9.03 Months	90% Confidence Interval 4.57
Placebo and Paclitaxel	Time to Disease Progression in Participants With PIK3CA/AKT1/PTEN-altered Tumors	4.93 Months	90% Confidence Interval 3.58

Secondary

Time to Disease Progression in Participants With PTEN-Low Tumors

Time to disease progression was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1.

Time frame: Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)

Population: ITT population included all randomized participants allocated to the treatment arm to which they were randomized. Participants with PTEN low tumors were evaluated for this endpoint.

Arm	Measure	Value (MEDIAN)	Dispersion
Ipatasertib and Paclitaxel	Time to Disease Progression in Participants With PTEN-Low Tumors	6.18 Months	90% Confidence Interval 3.65
Placebo and Paclitaxel	Time to Disease Progression in Participants With PTEN-Low Tumors	3.94 Months	90% Confidence Interval 2.53

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026

A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

PFS in Participants With Phosphatase and Tensin Homolog (PTEN)-Low Tumors

Progression Free Survival (PFS)

Duration of Response

Duration of Response in Participants With PIK3CA/AKT1/PTEN-altered Tumors

Duration of Response in Participants With PTEN-Low Tumors

Objective Response Rate (ORR)

ORR in Participants With PIK3CA/AKT1/PTEN-altered Tumors

ORR in Participants With PTEN-Low Tumors

OS in Participants With PIK3CA/AKT1/PTEN-altered Tumors

OS in Participants With PTEN-Low Tumors

Overall Survival (OS)

Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score

PFS in Participants With Phosphatidylinositol-4,5-bisphosphate 3-kinase Catalytic Subunit Alpha (PIK3CA)/ Protein Kinase B (AKT1)/ PTEN-altered Tumors

Pharmacokinetic Endpoint: Apparent Clearance Following Oral Dosing (CL/F) of Ipatasertib

Pharmacokinetic Endpoint: Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 24 Hours (AUC0-24h) of Ipatasertib

PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30

Safety: Percentage of Participants With Adverse Events

Time to Disease Progression

Time to Disease Progression in Participants With PIK3CA/AKT1/PTEN-altered Tumors

Time to Disease Progression in Participants With PTEN-Low Tumors