Breast Cancer
Conditions
Brief summary
This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years.
Interventions
DRUGTaselisib
Taselisib 4 mg was administered as two tablets of 2 mg each as per the schedule specified in the respective arm.
DRUGPlacebo
Placebo matching to taselisib was administered as per the schedule specified in the respective arm.
DRUGFulvestrant
Fulvestrant 500 mg was administered as two IM injections of 250 mg each as per the schedule specified in the respective arms.
Sponsors
Hoffmann-La Roche
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
No
Inclusion criteria
* Postmenopausal women with histologically or cytologically confirmed locally advanced or metastatic estrogen receptor (ER) positive breast cancer * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Participants for whom endocrine therapy (example \[e.g.\], fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study * Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer * Radiologic/objective evidence of breast cancer recurrence or progression while on or within 12 months of the end of adjuvant treatment with an aromatase inhibitor (AI), or progression while on or within 1 month of the end of prior AI treatment for locally advanced or metastatic breast cancer * Measurable disease via Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) or non-measurable, evaluable disease with at least one evaluable bone lesion via RECIST v1.1 * Consent to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (preferred) or a minimum of 20 (25 preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue for oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutation testing * A valid cobas PIK3CA mutation result by central testing is required * Adequate hematologic and end-organ function within 28 days prior to treatment initiation
Exclusion criteria
* Human epidermal growth factor receptor 2 (HER2)-positive disease by local laboratory testing (immunohistochemistry 3 positive \[IHC 3+\] staining or in situ hybridization positive) * Prior treatment with fulvestrant * Prior treatment with a phosphatidylinositol 3-kinase (PI3K) inhibitor, mammalian target of rapamycin (mTOR) inhibitor (e.g. everolimus), or protein kinase B (AKT) inhibitor * Prior anti-cancer therapy within 2 weeks prior to Day 1 of Cycle 1 * Prior radiation therapy within 2 weeks prior to Day 1 of Cycle 1 * All acute treatment-related toxicity must have resolved to Grade less than or equal to (\</=) 1 or be deemed stable by the Investigator * Prior treatment with greater than (\>) 1 cytotoxic chemotherapy regimen for metastatic breast cancer * Concurrent hormone replacement therapy * Known untreated or active central nervous system (CNS) metastases * Type 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medications * History of inflammatory bowel disease or active bowel inflammation * Clinically significant cardiac or pulmonary dysfunction * Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with human immunodeficiency virus (HIV), hepatitis B or C virus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) at Primary Analysis | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) | PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. |
| PFS as Assessed by Investigator Using RECIST v1.1 at Final Analysis | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years) | PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) at Primary Analysis | From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) | OS was defined as the time from the date of randomization to the date of death due to any cause. |
| OS at Final Analysis | From randomization up to death from any cause (up to approximately 6.2 years) | OS was defined as the time from the date of randomization to the date of death due to any cause. |
| Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Primary Analysis | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) | Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (\>/=) 24 weeks since randomization. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. |
| Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Final Analysis | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years) | Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (\>/=) 24 weeks since randomization. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. |
| Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Primary Analysis | Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) | Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. |
| Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Final Analysis | Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years) | Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. |
| PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1 at Primary Analysis | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) | PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. |
| Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1 at Primary Analysis | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) | PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). |
| Percentage of Participants With Adverse Events at Primary Analysis | From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years. | An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. |
| Percentage of Participants With Adverse Events at Final Analysis | From randomization up to approximately 6.2 years | An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. |
| Maximum Observed Plasma Concentration (Cmax) of Taselisib | 1 to 4 hours (hrs) post-dose on Cycle (C) 1, Day (D) 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1 (each cycle=28 days) | — |
| Minimum Observed Plasma Concentration (Cmin) of Taselisib | 1 to 4 hrs post-dose on Cycle 1, Day 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1; 0 to 3 hrs pre-dose on Cycle 6, Day 1 (each cycle=28 days) | — |
| Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Baseline, C2D1 up to C7D1 (each cycle=28 days) | The EORTC QLQ-C30 consists of 30 questions that comprise aspects of participant's functioning assessment (physical, emotional, role, cognitive, and social); symptom scales (fatigue; nausea, vomiting, and pain; the global health/quality of life \[QoL\]); and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties), within a recall period of the past week. Most questions used a 4-point scale (1=Not at all to 4=Very much; two questions used a 7-point scale (1=Very poor to 7=Excellent). Scores were averaged and transformed to a 0-100 scale; a higher score for Global Qol/functional scales=better level of functioning; a higher score for symptom scale=greater degree of symptoms. |
| Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Baseline, C2D1 up to C7D1 (each cycle=28 days) | EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores were averaged and transformed to a 0-100 scale. Higher scores for the functional scales indicated a higher/better level of functioning/healthy functioning. Higher scores for the symptom scales indicated worse symptoms. |
| PFS as Assessed by BICR Using RECIST v1.1 at Final Analysis | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years) | PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. |
| Percentage of Participants With Objective Response (PR Plus CR), as Assessed Using RECIST v.1.1 at Final Analysis | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years) | PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). |
Countries
Australia, Austria, Bosnia and Herzegovina, Bulgaria, Canada, China, Colombia, Czechia, Finland, France, Germany, Greece, Italy, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russia, Serbia, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United States
Participant flow
Recruitment details
This study was conducted at 155 centers in 28 countries.
Pre-assignment details
The study enrolled postmenopausal women with estrogen receptor-positive and human epidermal receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who had disease recurrence or progression during or after aromatase inhibitor therapy. Randomization was stratified by three factors: 1) visceral versus non-visceral disease, 2) sensitivity versus non-sensitivity to most recent endocrine therapy, and 3) geographical region.
Participants by arm
| Arm | Count |
|---|---|
| Placebo+Fulvestrant Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor. | 214 |
| Taselisib+Fulvestrant Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor. | 417 |
| Total | 631 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 100 | 197 |
| Overall Study | Lost to Follow-up | 4 | 15 |
| Overall Study | Reason Not Specified | 85 | 165 |
| Overall Study | Study Terminated by Sponsor | 1 | 3 |
| Overall Study | Withdrawal by Participant | 24 | 37 |
Baseline characteristics
| Characteristic | Taselisib+Fulvestrant | Total | Placebo+Fulvestrant |
|---|---|---|---|
| Age, Continuous | 60.1 years STANDARD_DEVIATION 9.9 | 60.3 years STANDARD_DEVIATION 9.9 | 60.7 years STANDARD_DEVIATION 10 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 24 Participants | 37 Participants | 13 Participants |
| Race/Ethnicity, Customized Asian | 72 Participants | 110 Participants | 38 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 48 Participants | 74 Participants | 26 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 3 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 334 Participants | 500 Participants | 166 Participants |
| Race/Ethnicity, Customized Not Stated | 15 Participants | 30 Participants | 15 Participants |
| Race/Ethnicity, Customized Unknown | 20 Participants | 27 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 285 Participants | 432 Participants | 147 Participants |
| Sex: Female, Male Female | 417 Participants | 631 Participants | 214 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 | 100 / 214 | 197 / 417 |
| other Total, other adverse events | 183 / 213 | 396 / 416 |
| serious Total, serious adverse events | 23 / 213 | 154 / 416 |
Outcome results
Primary
PFS as Assessed by Investigator Using RECIST v1.1 at Final Analysis
PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Time frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)
Population: Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo+Fulvestrant | PFS as Assessed by Investigator Using RECIST v1.1 at Final Analysis | 5.55 months |
| Taselisib+Fulvestrant | PFS as Assessed by Investigator Using RECIST v1.1 at Final Analysis | 8.05 months |
p-value: 0.000895% CI: [0.58, 0.87]Log Rank
Primary
Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) at Primary Analysis
PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Time frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Population: Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo+Fulvestrant | Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) at Primary Analysis | 5.39 months |
| Taselisib+Fulvestrant | Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) at Primary Analysis | 7.43 months |
p-value: 0.003795% CI: [0.56, 0.89]Log Rank
Secondary
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score
The EORTC QLQ-C30 consists of 30 questions that comprise aspects of participant's functioning assessment (physical, emotional, role, cognitive, and social); symptom scales (fatigue; nausea, vomiting, and pain; the global health/quality of life \[QoL\]); and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties), within a recall period of the past week. Most questions used a 4-point scale (1=Not at all to 4=Very much; two questions used a 7-point scale (1=Very poor to 7=Excellent). Scores were averaged and transformed to a 0-100 scale; a higher score for Global Qol/functional scales=better level of functioning; a higher score for symptom scale=greater degree of symptoms.
Time frame: Baseline, C2D1 up to C7D1 (each cycle=28 days)
Population: Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment. Data are reported for evaluable participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Cognitive Functioning: Baseline | 85.3 score on a scale | Standard Deviation 18.1 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Financial Difficulties: Change at C5D1 | -0.4 score on a scale | Standard Deviation 28 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Diarrhoea: Change at C7D1 | 1.1 score on a scale | Standard Deviation 20.7 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Financial Difficulties: Change at C6D1 | 5.6 score on a scale | Standard Deviation 30.1 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Constipation: Baseline | 15.8 score on a scale | Standard Deviation 23.9 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Financial Difficulties: Change at C7D1 | -0.6 score on a scale | Standard Deviation 26.1 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Dyspnoea: Baseline | 15.0 score on a scale | Standard Deviation 23 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Global Health Status/ QoL: Baseline | 65.2 score on a scale | Standard Deviation 18.4 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Appetite Loss: Change at C5D1 | -0.4 score on a scale | Standard Deviation 26.6 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Global Health Status/ QoL: Change at C2D1 | -0.1 score on a scale | Standard Deviation 16.7 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Dyspnoea: Change at C2D1 | 4.1 score on a scale | Standard Deviation 23.5 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Global Health Status/ QoL: Change at C3D1 | -1.0 score on a scale | Standard Deviation 18.5 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Constipation: Change at C2D1 | 0.0 score on a scale | Standard Deviation 24 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Global Health Status/ QoL: Change at C4D1 | -1.5 score on a scale | Standard Deviation 18.6 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Dyspnoea: Change at C3D1 | 2.8 score on a scale | Standard Deviation 20.3 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Global Health Status/ QoL: Change at C5D1 | 0.3 score on a scale | Standard Deviation 19.9 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Cognitive Functioning: Change at C2D1 | 0.7 score on a scale | Standard Deviation 16.5 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Global Health Status/ QoL: Change at C6D1 | -1.6 score on a scale | Standard Deviation 18.6 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Dyspnoea: Change at C4D1 | 0.7 score on a scale | Standard Deviation 23.2 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Global Health Status/ QoL: Change at C7D1 | -1.1 score on a scale | Standard Deviation 18.9 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Constipation: Change at C3D1 | -2.3 score on a scale | Standard Deviation 25 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Insomnia: Baseline | 26.0 score on a scale | Standard Deviation 27.6 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Dyspnoea: Change at C5D1 | 2.6 score on a scale | Standard Deviation 26.5 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Insomnia: Change at C2D1 | -0.9 score on a scale | Standard Deviation 24.4 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Appetite Loss: Change at C2D1 | -0.2 score on a scale | Standard Deviation 25.7 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Insomnia: Change at C3D1 | -3.4 score on a scale | Standard Deviation 30.1 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Dyspnoea: Change at C6D1 | 3.0 score on a scale | Standard Deviation 26.6 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Insomnia: Change at C4D1 | -4.0 score on a scale | Standard Deviation 28.9 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Constipation: Change at C4D1 | -2.7 score on a scale | Standard Deviation 24.6 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Insomnia: Change at C5D1 | -0.4 score on a scale | Standard Deviation 29.1 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Dyspnoea: Change at C7D1 | 1.7 score on a scale | Standard Deviation 24.5 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Insomnia: Change at C6D1 | -2.0 score on a scale | Standard Deviation 30.3 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Cognitive Functioning: Change at C3D1 | 0.9 score on a scale | Standard Deviation 17.9 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Insomnia: Change at C7D1 | -4.1 score on a scale | Standard Deviation 28.2 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Emotional Functioning: Baseline | 73.1 score on a scale | Standard Deviation 22.1 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Nausea/Vomiting: Baseline | 5.9 score on a scale | Standard Deviation 13.4 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Constipation: Change at C5D1 | -1.3 score on a scale | Standard Deviation 22.7 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Nausea/Vomiting: Change at C2D1 | 0.1 score on a scale | Standard Deviation 11.9 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Emotional Functioning: Change at C2D1 | 4.0 score on a scale | Standard Deviation 17.9 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Nausea/Vomiting: Change at C3D1 | 0.7 score on a scale | Standard Deviation 15.2 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Appetite Loss: Change at C6D1 | -0.5 score on a scale | Standard Deviation 22.3 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Nausea/Vomiting: Change at C4D1 | 0.3 score on a scale | Standard Deviation 17.9 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Emotional Functioning: Change at C3D1 | 4.5 score on a scale | Standard Deviation 19.1 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Nausea/Vomiting: Change at C5D1 | -1.1 score on a scale | Standard Deviation 18.3 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Constipation: Change at C6D1 | -3.0 score on a scale | Standard Deviation 27.3 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Nausea/Vomiting: Change at C6D1 | 1.5 score on a scale | Standard Deviation 18 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Emotional Functioning: Change at C4D1 | 4.5 score on a scale | Standard Deviation 18.5 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Nausea/Vomiting: Change at C7D1 | 2.6 score on a scale | Standard Deviation 15.5 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Cognitive Functioning: Change at C4D1 | 1.8 score on a scale | Standard Deviation 18.9 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Pain: Baseline | 28.0 score on a scale | Standard Deviation 25.4 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Emotional Functioning: Change at C5D1 | 5.2 score on a scale | Standard Deviation 20.1 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Pain: Change at C2D1 | -0.2 score on a scale | Standard Deviation 24 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Constipation: Change at C7D1 | -4.6 score on a scale | Standard Deviation 24.5 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Pain: Change at C3D1 | -3.7 score on a scale | Standard Deviation 23.3 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Emotional Functioning: Change at C6D1 | 2.1 score on a scale | Standard Deviation 20.5 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Pain: Change at C4D1 | -3.2 score on a scale | Standard Deviation 24.7 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Appetite Loss: Change at C4D1 | -1.7 score on a scale | Standard Deviation 26.1 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Pain: Change at C5D1 | -3.3 score on a scale | Standard Deviation 24.2 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Emotional Functioning: Change at C7D1 | 5.3 score on a scale | Standard Deviation 20.7 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Pain: Change at C6D1 | -1.0 score on a scale | Standard Deviation 23 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Diarrhoea: Baseline | 6.3 score on a scale | Standard Deviation 15.1 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Pain: Change at C7D1 | 0.3 score on a scale | Standard Deviation 23.5 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Fatigue: Baseline | 30.8 score on a scale | Standard Deviation 22.5 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Physical Functioning: Baseline | 76.7 score on a scale | Standard Deviation 19.9 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Cognitive Functioning: Change at C5D1 | -1.5 score on a scale | Standard Deviation 17.7 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Physical Functioning: Change at C2D1 | -1.1 score on a scale | Standard Deviation 13.4 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Fatigue: Change at C2D1 | 2.0 score on a scale | Standard Deviation 19.2 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Physical Functioning: Change at C3D1 | 2.0 score on a scale | Standard Deviation 14.1 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Diarrhoea: Change at C2D1 | -0.5 score on a scale | Standard Deviation 17.9 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Physical Functioning: Change at C4D1 | 1.5 score on a scale | Standard Deviation 16.1 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Fatigue: Change at C3D1 | -1.5 score on a scale | Standard Deviation 19.5 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Physical Functioning: Change at C5D1 | 2.0 score on a scale | Standard Deviation 17.7 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Appetite Loss: Change at C7D1 | -5.7 score on a scale | Standard Deviation 28.7 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Physical Functioning: Change at C6D1 | 0.9 score on a scale | Standard Deviation 18.4 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Fatigue: Change at C4D1 | -0.2 score on a scale | Standard Deviation 19.1 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Physical Functioning: Change at C7D1 | 1.6 score on a scale | Standard Deviation 16.2 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Diarrhoea: Change at C3D1 | -0.9 score on a scale | Standard Deviation 16.6 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Role Functioning: Baseline | 79.1 score on a scale | Standard Deviation 24.6 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Fatigue: Change at C5D1 | -0.1 score on a scale | Standard Deviation 20.8 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Role Functioning: Change at C2D1 | -2.0 score on a scale | Standard Deviation 19.3 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Cognitive Functioning: Change at C6D1 | -0.5 score on a scale | Standard Deviation 18.5 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Role Functioning: Change at C3D1 | -0.4 score on a scale | Standard Deviation 23.4 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Fatigue: Change at C6D1 | 3.3 score on a scale | Standard Deviation 20 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Role Functioning: Change at C4D1 | 0.3 score on a scale | Standard Deviation 23 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Diarrhoea: Change at C4D1 | -2.7 score on a scale | Standard Deviation 21 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Role Functioning: Change at C5D1 | 1.8 score on a scale | Standard Deviation 22.5 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Fatigue: Change at C7D1 | 1.0 score on a scale | Standard Deviation 20 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Role Functioning: Change at C6D1 | -1.3 score on a scale | Standard Deviation 23.8 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Appetite Loss: Change at C3D1 | -4.3 score on a scale | Standard Deviation 27.2 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Role Functioning: Change at C7D1 | -0.3 score on a scale | Standard Deviation 22.6 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Financial Difficulties: Baseline | 18.5 score on a scale | Standard Deviation 25.8 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Social Functioning: Baseline | 83.2 score on a scale | Standard Deviation 21.8 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Diarrhoea: Change at C5D1 | -2.6 score on a scale | Standard Deviation 19.4 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Social Functioning: Change at C2D1 | -0.8 score on a scale | Standard Deviation 19.9 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Financial Difficulties: Change at C2D1 | -1.1 score on a scale | Standard Deviation 20.4 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Social Functioning: Change at C3D1 | 1.3 score on a scale | Standard Deviation 21.9 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Cognitive Functioning: Change at C7D1 | -2.3 score on a scale | Standard Deviation 18.1 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Social Functioning: Change at C4D1 | 1.8 score on a scale | Standard Deviation 18.2 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Financial Difficulties: Change at C3D1 | -0.9 score on a scale | Standard Deviation 24.9 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Social Functioning: Change at C5D1 | 0.9 score on a scale | Standard Deviation 19.4 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Diarrhoea: Change at C6D1 | -2.0 score on a scale | Standard Deviation 17.4 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Social Functioning: Change at C6D1 | -0.8 score on a scale | Standard Deviation 20.1 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Financial Difficulties: Change at C4D1 | 0.7 score on a scale | Standard Deviation 25.1 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Social Functioning: Change at C7D1 | 0.6 score on a scale | Standard Deviation 21.2 |
| Placebo+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Appetite Loss: Baseline | 15.9 score on a scale | Standard Deviation 25.9 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Social Functioning: Change at C7D1 | 0.1 score on a scale | Standard Deviation 19.7 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Appetite Loss: Baseline | 15.3 score on a scale | Standard Deviation 23.3 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Appetite Loss: Change at C2D1 | 6.2 score on a scale | Standard Deviation 26.2 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Appetite Loss: Change at C3D1 | 8.7 score on a scale | Standard Deviation 28.1 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Appetite Loss: Change at C4D1 | 8.4 score on a scale | Standard Deviation 28.1 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Appetite Loss: Change at C5D1 | 6.0 score on a scale | Standard Deviation 27.2 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Appetite Loss: Change at C6D1 | 6.6 score on a scale | Standard Deviation 27.2 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Appetite Loss: Change at C7D1 | 4.6 score on a scale | Standard Deviation 26.5 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Cognitive Functioning: Baseline | 85.9 score on a scale | Standard Deviation 18.7 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Cognitive Functioning: Change at C2D1 | -1.1 score on a scale | Standard Deviation 16.8 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Cognitive Functioning: Change at C3D1 | -2.9 score on a scale | Standard Deviation 19.1 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Cognitive Functioning: Change at C4D1 | -1.7 score on a scale | Standard Deviation 18.4 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Cognitive Functioning: Change at C5D1 | -3.2 score on a scale | Standard Deviation 17.7 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Cognitive Functioning: Change at C6D1 | -2.8 score on a scale | Standard Deviation 17.6 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Cognitive Functioning: Change at C7D1 | -0.8 score on a scale | Standard Deviation 18.8 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Constipation: Baseline | 14.5 score on a scale | Standard Deviation 23.7 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Constipation: Change at C2D1 | -6.0 score on a scale | Standard Deviation 21.1 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Constipation: Change at C3D1 | -4.9 score on a scale | Standard Deviation 20.8 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Constipation: Change at C4D1 | -5.5 score on a scale | Standard Deviation 22 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Constipation: Change at C5D1 | -4.0 score on a scale | Standard Deviation 21 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Constipation: Change at C6D1 | -3.5 score on a scale | Standard Deviation 21.8 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Constipation: Change at C7D1 | -6.9 score on a scale | Standard Deviation 22.5 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Diarrhoea: Baseline | 5.0 score on a scale | Standard Deviation 14.4 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Diarrhoea: Change at C2D1 | 10.2 score on a scale | Standard Deviation 22.4 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Diarrhoea: Change at C3D1 | 13.7 score on a scale | Standard Deviation 26.3 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Diarrhoea: Change at C4D1 | 13.1 score on a scale | Standard Deviation 28.9 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Diarrhoea: Change at C5D1 | 11.1 score on a scale | Standard Deviation 27.7 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Diarrhoea: Change at C6D1 | 14.0 score on a scale | Standard Deviation 29.1 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Diarrhoea: Change at C7D1 | 15.6 score on a scale | Standard Deviation 30.9 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Dyspnoea: Baseline | 15.4 score on a scale | Standard Deviation 22.2 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Dyspnoea: Change at C2D1 | -2.1 score on a scale | Standard Deviation 19.5 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Dyspnoea: Change at C3D1 | 0.0 score on a scale | Standard Deviation 20.9 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Dyspnoea: Change at C4D1 | 0.0 score on a scale | Standard Deviation 23.3 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Dyspnoea: Change at C5D1 | 1.6 score on a scale | Standard Deviation 23.2 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Dyspnoea: Change at C6D1 | 0.2 score on a scale | Standard Deviation 23.4 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Dyspnoea: Change at C7D1 | -2.1 score on a scale | Standard Deviation 21.2 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Emotional Functioning: Baseline | 71.9 score on a scale | Standard Deviation 22.1 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Emotional Functioning: Change at C2D1 | 5.1 score on a scale | Standard Deviation 18.5 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Emotional Functioning: Change at C3D1 | 2.3 score on a scale | Standard Deviation 21.6 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Emotional Functioning: Change at C4D1 | 2.6 score on a scale | Standard Deviation 19.7 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Emotional Functioning: Change at C5D1 | -0.4 score on a scale | Standard Deviation 21.8 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Emotional Functioning: Change at C6D1 | 2.4 score on a scale | Standard Deviation 21.6 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Emotional Functioning: Change at C7D1 | 2.8 score on a scale | Standard Deviation 19.7 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Fatigue: Baseline | 30.8 score on a scale | Standard Deviation 22 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Fatigue: Change at C2D1 | -0.5 score on a scale | Standard Deviation 18.8 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Fatigue: Change at C3D1 | 1.8 score on a scale | Standard Deviation 21.5 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Fatigue: Change at C4D1 | 2.4 score on a scale | Standard Deviation 21.9 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Fatigue: Change at C5D1 | 2.8 score on a scale | Standard Deviation 20.4 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Fatigue: Change at C6D1 | 2.4 score on a scale | Standard Deviation 20.5 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Fatigue: Change at C7D1 | 1.8 score on a scale | Standard Deviation 20.5 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Financial Difficulties: Baseline | 19.2 score on a scale | Standard Deviation 27.1 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Financial Difficulties: Change at C2D1 | -2.8 score on a scale | Standard Deviation 21.4 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Financial Difficulties: Change at C3D1 | -1.6 score on a scale | Standard Deviation 24.4 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Financial Difficulties: Change at C4D1 | -0.3 score on a scale | Standard Deviation 23.7 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Financial Difficulties: Change at C5D1 | 0.3 score on a scale | Standard Deviation 24.9 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Financial Difficulties: Change at C6D1 | 0.4 score on a scale | Standard Deviation 23.6 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Financial Difficulties: Change at C7D1 | 2.1 score on a scale | Standard Deviation 23.1 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Global Health Status/ QoL: Baseline | 67.4 score on a scale | Standard Deviation 20.3 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Global Health Status/ QoL: Change at C2D1 | 1.0 score on a scale | Standard Deviation 19.9 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Global Health Status/ QoL: Change at C3D1 | -1.5 score on a scale | Standard Deviation 20.9 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Global Health Status/ QoL: Change at C4D1 | -1.6 score on a scale | Standard Deviation 20.3 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Global Health Status/ QoL: Change at C5D1 | -2.8 score on a scale | Standard Deviation 20.3 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Global Health Status/ QoL: Change at C6D1 | -3.4 score on a scale | Standard Deviation 19.5 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Global Health Status/ QoL: Change at C7D1 | -1.0 score on a scale | Standard Deviation 18.9 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Insomnia: Baseline | 26.5 score on a scale | Standard Deviation 27.7 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Insomnia: Change at C2D1 | -3.8 score on a scale | Standard Deviation 23.7 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Insomnia: Change at C3D1 | -4.1 score on a scale | Standard Deviation 26.4 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Insomnia: Change at C4D1 | -1.0 score on a scale | Standard Deviation 26.8 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Insomnia: Change at C5D1 | -3.9 score on a scale | Standard Deviation 25.6 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Insomnia: Change at C6D1 | -2.4 score on a scale | Standard Deviation 28.2 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Insomnia: Change at C7D1 | -1.8 score on a scale | Standard Deviation 27.2 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Nausea/Vomiting: Baseline | 6.7 score on a scale | Standard Deviation 13.7 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Nausea/Vomiting: Change at C2D1 | 1.6 score on a scale | Standard Deviation 18.1 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Nausea/Vomiting: Change at C3D1 | 2.2 score on a scale | Standard Deviation 17.6 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Nausea/Vomiting: Change at C4D1 | 2.3 score on a scale | Standard Deviation 18.6 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Nausea/Vomiting: Change at C5D1 | 0.5 score on a scale | Standard Deviation 15.4 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Nausea/Vomiting: Change at C6D1 | -0.6 score on a scale | Standard Deviation 15.9 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Nausea/Vomiting: Change at C7D1 | 2.2 score on a scale | Standard Deviation 18.8 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Pain: Baseline | 27.1 score on a scale | Standard Deviation 24.9 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Pain: Change at C2D1 | -5.0 score on a scale | Standard Deviation 20.8 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Pain: Change at C3D1 | -3.5 score on a scale | Standard Deviation 22.6 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Pain: Change at C4D1 | -1.7 score on a scale | Standard Deviation 24.2 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Pain: Change at C5D1 | -4.3 score on a scale | Standard Deviation 22.9 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Pain: Change at C6D1 | -2.2 score on a scale | Standard Deviation 22.5 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Pain: Change at C7D1 | -4.4 score on a scale | Standard Deviation 19.8 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Physical Functioning: Baseline | 78.4 score on a scale | Standard Deviation 18.8 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Physical Functioning: Change at C2D1 | 1.6 score on a scale | Standard Deviation 12.7 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Physical Functioning: Change at C3D1 | 0.8 score on a scale | Standard Deviation 15.7 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Physical Functioning: Change at C4D1 | 0.3 score on a scale | Standard Deviation 15.7 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Physical Functioning: Change at C5D1 | 1.0 score on a scale | Standard Deviation 13.5 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Physical Functioning: Change at C6D1 | 1.1 score on a scale | Standard Deviation 14.9 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Physical Functioning: Change at C7D1 | 0.6 score on a scale | Standard Deviation 14.2 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Role Functioning: Baseline | 78.7 score on a scale | Standard Deviation 24 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Role Functioning: Change at C2D1 | 1.7 score on a scale | Standard Deviation 21.5 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Role Functioning: Change at C3D1 | -1.0 score on a scale | Standard Deviation 23.9 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Role Functioning: Change at C4D1 | 0.4 score on a scale | Standard Deviation 24.2 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Role Functioning: Change at C5D1 | -1.6 score on a scale | Standard Deviation 21.6 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Role Functioning: Change at C6D1 | -1.6 score on a scale | Standard Deviation 23.4 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Role Functioning: Change at C7D1 | 0.0 score on a scale | Standard Deviation 22.9 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Social Functioning: Baseline | 81.2 score on a scale | Standard Deviation 23.1 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Social Functioning: Change at C2D1 | 2.7 score on a scale | Standard Deviation 20 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Social Functioning: Change at C3D1 | -0.8 score on a scale | Standard Deviation 23.2 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Social Functioning: Change at C4D1 | -0.5 score on a scale | Standard Deviation 21.3 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Social Functioning: Change at C5D1 | -1.0 score on a scale | Standard Deviation 23.3 |
| Taselisib+Fulvestrant | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | Social Functioning: Change at C6D1 | -1.6 score on a scale | Standard Deviation 23.4 |
Secondary
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores were averaged and transformed to a 0-100 scale. Higher scores for the functional scales indicated a higher/better level of functioning/healthy functioning. Higher scores for the symptom scales indicated worse symptoms.
Time frame: Baseline, C2D1 up to C7D1 (each cycle=28 days)
Population: Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment. Data are reported for evaluable participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Systematic Therapy SEs: Change at C4D1 | 1.5 score on a scale | Standard Deviation 13.2 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Enjoyment: Change at C5D1 | -4.8 score on a scale | Standard Deviation 23 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Enjoyment: Change at C6D1 | -6.7 score on a scale | Standard Deviation 14.9 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Enjoyment: Change at C7D1 | -13.3 score on a scale | Standard Deviation 29.8 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Functioning: Baseline | 89.6 score on a scale | Standard Deviation 17.9 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Functioning: Change at C2D1 | 1.6 score on a scale | Standard Deviation 11 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Functioning: Change at C3D1 | 1.4 score on a scale | Standard Deviation 10.6 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Functioning: Change at C4D1 | 1.9 score on a scale | Standard Deviation 15.4 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Functioning: Change at C5D1 | -0.8 score on a scale | Standard Deviation 20.6 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Functioning: Change at C6D1 | 2.4 score on a scale | Standard Deviation 18.8 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Functioning: Change at C7D1 | 2.7 score on a scale | Standard Deviation 18.1 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Systematic Therapy SEs: Baseline | 15.7 score on a scale | Standard Deviation 14.2 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Systematic Therapy SEs: Change at C2D1 | 0.2 score on a scale | Standard Deviation 11.4 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Systematic Therapy SEs: Change at C3D1 | 1.2 score on a scale | Standard Deviation 14.4 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Enjoyment: Change at C4D1 | -8.3 score on a scale | Standard Deviation 15.4 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Systematic Therapy SEs: Change at C5D1 | 2.4 score on a scale | Standard Deviation 13.8 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Systematic Therapy SEs: Change at C6D1 | 2.9 score on a scale | Standard Deviation 15.2 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Systematic Therapy SEs: Change at C7D1 | 3.5 score on a scale | Standard Deviation 16.7 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Upset by Hair Loss: Baseline | 23.2 score on a scale | Standard Deviation 28.2 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Upset by Hair Loss: Change at C2D1 | -11.9 score on a scale | Standard Deviation 28.1 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Upset by Hair Loss: Change at C3D1 | -7.7 score on a scale | Standard Deviation 30.9 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Upset by Hair Loss: Change at C4D1 | 2.6 score on a scale | Standard Deviation 16.5 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Upset by Hair Loss: Change at C5D1 | 0.0 score on a scale | Standard Deviation 25.2 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Upset by Hair Loss: Change at C6D1 | 11.1 score on a scale | Standard Deviation 27.2 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Upset by Hair Loss: Change at C7D1 | 4.2 score on a scale | Standard Deviation 11.8 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Arm Symptoms: Baseline | 15.5 score on a scale | Standard Deviation 18.8 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Arm Symptoms: Change at C2D1 | 0.1 score on a scale | Standard Deviation 17.4 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Arm Symptoms: Change at C3D1 | -0.7 score on a scale | Standard Deviation 19.5 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Arm Symptoms: Change at C4D1 | -1.4 score on a scale | Standard Deviation 21.9 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Arm Symptoms: Change at C5D1 | 0.8 score on a scale | Standard Deviation 17 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Arm Symptoms: Change at C6D1 | 1.1 score on a scale | Standard Deviation 20.8 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Arm Symptoms: Change at C7D1 | -1.2 score on a scale | Standard Deviation 19.7 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Body Image: Baseline | 82.0 score on a scale | Standard Deviation 21.7 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Body Image: Change at C2D1 | 1.8 score on a scale | Standard Deviation 14.9 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Body Image: Change at C3D1 | 1.6 score on a scale | Standard Deviation 18 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Body Image: Change at C4D1 | 1.1 score on a scale | Standard Deviation 17.8 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Body Image: Change at C5D1 | 0.2 score on a scale | Standard Deviation 19.5 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Body Image: Change at C6D1 | 1.1 score on a scale | Standard Deviation 21 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Body Image: Change at C7D1 | 5.6 score on a scale | Standard Deviation 18.8 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Breast Symptoms: Baseline | 8.7 score on a scale | Standard Deviation 14.6 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Breast Symptoms: Change at C2D1 | 0.0 score on a scale | Standard Deviation 13.7 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Breast Symptoms: Change at C3D1 | -0.8 score on a scale | Standard Deviation 13.3 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Breast Symptoms: Change at C4D1 | 0.1 score on a scale | Standard Deviation 14.2 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Breast Symptoms: Change at C5D1 | -0.9 score on a scale | Standard Deviation 14.5 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Breast Symptoms: Change at C6D1 | 1.7 score on a scale | Standard Deviation 16 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Breast Symptoms: Change at C7D1 | 0.3 score on a scale | Standard Deviation 12.6 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Future Perspective: Baseline | 47.4 score on a scale | Standard Deviation 31.5 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Future Perspective: Change at C2D1 | 3.4 score on a scale | Standard Deviation 30.1 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Future Perspective: Change at C3D1 | 5.1 score on a scale | Standard Deviation 29.5 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Future Perspective: Change at C4D1 | 6.0 score on a scale | Standard Deviation 30.7 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Future Perspective: Change at C5D1 | 6.0 score on a scale | Standard Deviation 30.3 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Future Perspective: Change at C6D1 | 6.9 score on a scale | Standard Deviation 28.8 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Future Perspective: Change at C7D1 | 12.9 score on a scale | Standard Deviation 29.4 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Enjoyment: Baseline | 51.9 score on a scale | Standard Deviation 26.7 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Enjoyment: Change at C2D1 | 5.9 score on a scale | Standard Deviation 21.2 |
| Placebo+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Enjoyment: Change at C3D1 | 4.8 score on a scale | Standard Deviation 22.1 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Future Perspective: Change at C7D1 | 7.0 score on a scale | Standard Deviation 30.2 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Enjoyment: Change at C4D1 | 4.2 score on a scale | Standard Deviation 24.7 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Arm Symptoms: Change at C4D1 | -5.8 score on a scale | Standard Deviation 15.8 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Enjoyment: Change at C5D1 | 2.6 score on a scale | Standard Deviation 29.7 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Breast Symptoms: Change at C4D1 | -3.0 score on a scale | Standard Deviation 11.8 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Enjoyment: Change at C6D1 | -5.9 score on a scale | Standard Deviation 24.3 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Arm Symptoms: Change at C5D1 | -6.6 score on a scale | Standard Deviation 15.7 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Enjoyment: Change at C7D1 | 9.5 score on a scale | Standard Deviation 20.4 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Future Perspective: Change at C4D1 | 7.0 score on a scale | Standard Deviation 29.2 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Functioning: Baseline | 89.9 score on a scale | Standard Deviation 17.3 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Arm Symptoms: Change at C6D1 | -5.0 score on a scale | Standard Deviation 18.5 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Functioning: Change at C2D1 | 1.5 score on a scale | Standard Deviation 14.2 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Breast Symptoms: Change at C5D1 | -2.0 score on a scale | Standard Deviation 11.7 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Functioning: Change at C3D1 | 1.8 score on a scale | Standard Deviation 15.6 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Arm Symptoms: Change at C7D1 | -6.0 score on a scale | Standard Deviation 15.2 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Functioning: Change at C4D1 | 1.6 score on a scale | Standard Deviation 13.9 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Enjoyment: Change at C2D1 | 0.0 score on a scale | Standard Deviation 18.1 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Functioning: Change at C5D1 | 2.6 score on a scale | Standard Deviation 15.1 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Body Image: Baseline | 80.8 score on a scale | Standard Deviation 22.5 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Functioning: Change at C6D1 | 2.7 score on a scale | Standard Deviation 15 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Breast Symptoms: Change at C6D1 | -2.0 score on a scale | Standard Deviation 12.9 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Functioning: Change at C7D1 | 2.3 score on a scale | Standard Deviation 15.7 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Body Image: Change at C2D1 | 1.5 score on a scale | Standard Deviation 16.5 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Systematic Therapy SEs: Baseline | 14.7 score on a scale | Standard Deviation 12 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Future Perspective: Change at C5D1 | 5.0 score on a scale | Standard Deviation 26.8 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Systematic Therapy SEs: Change at C2D1 | 2.5 score on a scale | Standard Deviation 11 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Body Image: Change at C3D1 | 1.1 score on a scale | Standard Deviation 20.6 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Systematic Therapy SEs: Change at C3D1 | 4.0 score on a scale | Standard Deviation 13.6 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Breast Symptoms: Change at C7D1 | -3.2 score on a scale | Standard Deviation 13.1 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Systematic Therapy SEs: Change at C4D1 | 4.0 score on a scale | Standard Deviation 13.3 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Body Image: Change at C4D1 | 1.8 score on a scale | Standard Deviation 20.6 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Systematic Therapy SEs: Change at C5D1 | 5.5 score on a scale | Standard Deviation 14.1 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Enjoyment: Baseline | 62.8 score on a scale | Standard Deviation 26.6 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Systematic Therapy SEs: Change at C6D1 | 5.7 score on a scale | Standard Deviation 15.6 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Body Image: Change at C5D1 | 0.0 score on a scale | Standard Deviation 17.5 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Systematic Therapy SEs: Change at C7D1 | 4.8 score on a scale | Standard Deviation 15 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Future Perspective: Baseline | 47.3 score on a scale | Standard Deviation 29.6 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Upset by Hair Loss: Baseline | 27.0 score on a scale | Standard Deviation 29.2 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Body Image: Change at C6D1 | 0.4 score on a scale | Standard Deviation 18.2 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Upset by Hair Loss: Change at C2D1 | -4.3 score on a scale | Standard Deviation 22.3 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Future Perspective: Change at C6D1 | 9.0 score on a scale | Standard Deviation 31.4 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Upset by Hair Loss: Change at C3D1 | 0.0 score on a scale | Standard Deviation 26.7 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Body Image: Change at C7D1 | -0.3 score on a scale | Standard Deviation 18.2 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Upset by Hair Loss: Change at C4D1 | 0.0 score on a scale | Standard Deviation 29.2 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Future Perspective: Change at C2D1 | 6.8 score on a scale | Standard Deviation 27.4 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Upset by Hair Loss: Change at C5D1 | 10.7 score on a scale | Standard Deviation 27.3 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Breast Symptoms: Baseline | 11.0 score on a scale | Standard Deviation 14.1 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Upset by Hair Loss: Change at C6D1 | 16.7 score on a scale | Standard Deviation 30.2 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Sexual Enjoyment: Change at C3D1 | 1.3 score on a scale | Standard Deviation 24 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Upset by Hair Loss: Change at C7D1 | 14.1 score on a scale | Standard Deviation 32.9 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Breast Symptoms: Change at C2D1 | -3.0 score on a scale | Standard Deviation 11.8 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Arm Symptoms: Baseline | 19.3 score on a scale | Standard Deviation 21.1 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Future Perspective: Change at C3D1 | 4.3 score on a scale | Standard Deviation 30.5 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Arm Symptoms: Change at C2D1 | -5.4 score on a scale | Standard Deviation 15.6 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Breast Symptoms: Change at C3D1 | -3.5 score on a scale | Standard Deviation 11.6 |
| Taselisib+Fulvestrant | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | Arm Symptoms: Change at C3D1 | -6.1 score on a scale | Standard Deviation 17.4 |
Secondary
Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Final Analysis
Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Time frame: Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)
Population: Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment. Data are reported for participants with responses.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo+Fulvestrant | Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Final Analysis | 7.39 months |
| Taselisib+Fulvestrant | Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Final Analysis | 8.97 months |
p-value: 0.828695% CI: [0.51, 2.35]Log Rank
Secondary
Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Primary Analysis
Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Time frame: Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Population: Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment. Data are reported for participants with responses.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo+Fulvestrant | Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Primary Analysis | 7.23 months |
| Taselisib+Fulvestrant | Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Primary Analysis | 8.74 months |
p-value: 0.670895% CI: [0.23, 2.59]Log Rank
Secondary
Maximum Observed Plasma Concentration (Cmax) of Taselisib
Time frame: 1 to 4 hours (hrs) post-dose on Cycle (C) 1, Day (D) 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1 (each cycle=28 days)
Population: The Pharmacokinetic (PK) population included all participants who received at least one dose of taselisib and provided valid (adequately documented dose time and PK sample time) PK assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo+Fulvestrant | Maximum Observed Plasma Concentration (Cmax) of Taselisib | C2D1 | 66.6 ng/mL | Standard Deviation 35.2 |
| Placebo+Fulvestrant | Maximum Observed Plasma Concentration (Cmax) of Taselisib | C1D1 | 18.2 ng/mL | Standard Deviation 14.6 |
Secondary
Minimum Observed Plasma Concentration (Cmin) of Taselisib
Time frame: 1 to 4 hrs post-dose on Cycle 1, Day 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1; 0 to 3 hrs pre-dose on Cycle 6, Day 1 (each cycle=28 days)
Population: The PK population included all participants who received at least one dose of taselisib and provided valid (adequately documented dose time and PK sample time) PK assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo+Fulvestrant | Minimum Observed Plasma Concentration (Cmin) of Taselisib | C2D1 | 42.8 ng/mL | Standard Deviation 26.6 |
| Placebo+Fulvestrant | Minimum Observed Plasma Concentration (Cmin) of Taselisib | C6D1 | 35.3 ng/mL | Standard Deviation 31.5 |
Secondary
OS at Final Analysis
OS was defined as the time from the date of randomization to the date of death due to any cause.
Time frame: From randomization up to death from any cause (up to approximately 6.2 years)
Population: Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo+Fulvestrant | OS at Final Analysis | 27.93 months |
| Taselisib+Fulvestrant | OS at Final Analysis | 27.79 months |
p-value: 0.997495% CI: [0.75, 1.33]Log Rank
Secondary
Overall Survival (OS) at Primary Analysis
OS was defined as the time from the date of randomization to the date of death due to any cause.
Time frame: From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Population: Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo+Fulvestrant | Overall Survival (OS) at Primary Analysis | 23.56 months |
| Taselisib+Fulvestrant | Overall Survival (OS) at Primary Analysis | 26.81 months |
p-value: 0.415195% CI: [0.58, 1.25]Log Rank
Secondary
Percentage of Participants With Adverse Events at Final Analysis
An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
Time frame: From randomization up to approximately 6.2 years
Population: The safety-evaluable population included all randomized participants who received at least one dose of taselisib or placebo or fulvestrant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo+Fulvestrant | Percentage of Participants With Adverse Events at Final Analysis | 91.1 percentage of participants |
| Taselisib+Fulvestrant | Percentage of Participants With Adverse Events at Final Analysis | 97.1 percentage of participants |
Secondary
Percentage of Participants With Adverse Events at Primary Analysis
An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
Time frame: From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years.
Population: The safety-evaluable population included all randomized participants who received at least one dose of taselisib or placebo or fulvestrant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo+Fulvestrant | Percentage of Participants With Adverse Events at Primary Analysis | 89.7 percentage of participants |
| Taselisib+Fulvestrant | Percentage of Participants With Adverse Events at Primary Analysis | 95.4 percentage of participants |
Secondary
Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Final Analysis
Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (\>/=) 24 weeks since randomization. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Time frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)
Population: Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo+Fulvestrant | Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Final Analysis | 45.5 percentage of participants |
| Taselisib+Fulvestrant | Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Final Analysis | 59.5 percentage of participants |
95% CI: [1.2, 3]
Secondary
Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Primary Analysis
Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (\>/=) 24 weeks since randomization. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Time frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Population: Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo+Fulvestrant | Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Primary Analysis | 37.3 percentage of participants |
| Taselisib+Fulvestrant | Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Primary Analysis | 51.5 percentage of participants |
95% CI: [1.2, 2.9]
Secondary
Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1 at Primary Analysis
PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).
Time frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Population: Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo+Fulvestrant | Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1 at Primary Analysis | 11.9 percentage of participants |
| Taselisib+Fulvestrant | Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1 at Primary Analysis | 28.0 percentage of participants |
p-value: 0.000295% CI: [1.6, 5.4]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Objective Response (PR Plus CR), as Assessed Using RECIST v.1.1 at Final Analysis
PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).
Time frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)
Population: Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo+Fulvestrant | Percentage of Participants With Objective Response (PR Plus CR), as Assessed Using RECIST v.1.1 at Final Analysis | 13.4 percentage of participants |
| Taselisib+Fulvestrant | Percentage of Participants With Objective Response (PR Plus CR), as Assessed Using RECIST v.1.1 at Final Analysis | 31.1 percentage of participants |
p-value: <0.000195% CI: [1.7, 5.4]Cochran-Mantel-Haenszel
Secondary
PFS as Assessed by BICR Using RECIST v1.1 at Final Analysis
PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Time frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)
Population: Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo+Fulvestrant | PFS as Assessed by BICR Using RECIST v1.1 at Final Analysis | 5.55 months |
| Taselisib+Fulvestrant | PFS as Assessed by BICR Using RECIST v1.1 at Final Analysis | 9.20 months |
p-value: 0.009595% CI: [0.56, 0.92]Log Rank
Secondary
PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1 at Primary Analysis
PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Time frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Population: Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo+Fulvestrant | PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1 at Primary Analysis | 5.39 months |
| Taselisib+Fulvestrant | PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1 at Primary Analysis | 8.97 months |
p-value: 0.002395% CI: [0.51, 0.86]Log Rank