Breast Cancer
Conditions
Brief summary
This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and placebo in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2 (HER2) untreated, Stage I-III operable breast cancer. Participants will be randomized into one of the two treatment arms with a 1:1 randomization ratio. Letrozole at 2.5 milligrams (mg) will be dosed once daily plus either Taselisib at 4 mg (two 2-mg tablets) or placebo on a 5 days-on/ 2 days-off schedule for a total of 16 weeks.
Interventions
DRUGLetrozole
Letrozole tablets will be administered orally at 2.5 mg QD for 16 weeks.
OTHERPlacebo
Placebo tablets matched to taselisib formulation will be administered orally daily on 5 days-on/2 days-off schedule for up to 16 weeks.
DRUGTaselisib
Taselisib will be administered orally at 4 mg (two 2 mg tablets) daily.
Sponsors
SOLTI Breast Cancer Research Group
Breast International Group
Austrian Breast and Colorectal Cancer Group
Genentech, Inc.
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
* Female participants * Postmenopausal status * Histologically confirmed invasive breast carcinoma, with all of the following characteristics: (i) Primary tumor greater than or equal to (\>/=) 2 centimeters (cm) in largest diameter (cT1-3) by MRI; (ii) Stage I to operable Stage III breast cancer; (iii) Documented absence of distant metastases (M0) * Estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer * Breast cancer eligible for primary surgery * Tumor tissue from formalin-fixed paraffin-embedded cores (FFPE) core biopsy of breast primary tumor that is confirmed as evaluable for phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutation status by central histopathology laboratory * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Fasting glucose less than or equal to (\</=) 125 milligrams per deciliter (mg/dL) * Adequate hematological, renal, and hepatic function * Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol, in the investigator's judgment
Exclusion criteria
* Any prior treatment for primary invasive breast cancer * Participants with cT4 or cN3 stage breast tumors * Bilateral invasive, multicentric, or metastatic breast cancer * Participants who have undergone excisional biopsy of primary tumor and/or axillary lymph nodes or sentinel lymph node biopsy * Type 1 or 2 diabetes requiring antihyperglycemic medication * Inability or unwillingness to swallow pills * Malabsorption syndrome or other condition that would interfere with enteric absorption * History of prior or currently active small or large intestine inflammation (such as Crohn's disease or ulcerative colitis). Any predisposition for gastrointestinal (GI) toxicity requires prior approval from the Medical Monitor. * Congenital long QT syndrome or QT interval corrected using Fridericia's formula (QTcF) \>470 milliseconds (msec) * Diffusing capacity of the lungs for carbon monoxide (DLCO) \<60% of the predicted values * Clinically significant (i.e., active) cardiovascular disease, uncontrolled hypertension, unstable angina, history of myocardial infarction, cardiac failure class II-IV * Any contraindication to MRI examination * Active infection requiring intravenous antibiotics * Participants requiring any daily supplemental oxygen * Clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis * Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or renders the participants at high risk from treatment complications * Significant traumatic injury within 3 weeks prior to initiation of study treatment * Major surgical procedure within 4 weeks prior to initiation of study treatment * Inability to comply with study and follow-up procedures * History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Objective Response (OR) by Centrally Assessed Breast Magnetic Resonance Imaging (MRI) Via Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1 | From Baseline to 16 weeks | Objective response rate (ORR) was defined as proportion of participants achieving complete response (CR) or partial response (PR). As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Percentage of Participants With Total Pathologic Complete Response (Total pCR), Defined as Having pCR in Both Breast and Axilla, Using American Joint Committee on Cancer (AJCC) Staging System | From Baseline to 16 weeks | Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes ( i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition). |
| Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in Phosphatidylinositol-4,5-Bisphosphate 3-Kinase, Catalytic Subunit Alpha (PIK3CA) Mutant (MT) Participants | From Baseline to 16 weeks | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Percentage of Participants With Total pCR , Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA MT Participants | From Baseline to 16 weeks | Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA MT Participants | From Baseline to 16 weeks | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA WT Participants | From Baseline to 16 weeks | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA MT Participants | From Baseline to 16 weeks | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA WT Participants | From Baseline to 16 weeks | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Central Assessments of Changes in Ki67 Levels | From Baseline to Week 3 and Surgery (Weeks 17-18); and Week 3 to Surgery (Weeks 17-18) | Ki67 is a prognostic marker and is used to evaluate the proliferative activity of breast cancer. |
| Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in PIK3CA Wildtype (WT) Participants | From Baseline to 16 weeks | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Percent Change From Baseline to Surgery in Enhancing Tumor Volume as Measured by Breast MRI | From Baseline to Surgery (Weeks 17-18) | — |
| Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Weeks 1, 5, 9, 13, 16, 4-week Post-Surgery | EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. The first 28 questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting \[N/V\], constipation, and pain) and a single item (financial difficulties). The last 2 questions represented the participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement. Here, Post surgery= PS. |
| Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Weeks 1, 5, 9, 13, 16, 4-week Post-Surgery | EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and four symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores were averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL. Here, Post surgery= PS. |
| Percentage of Participants With Adverse Events | Baseline up to 22 weeks | An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Preoperative Endocrine Prognostic Index (PEPI ) Score | Week 16 | To obtain the PEPI score, risk points for relapse-free survival (RFS) and breast cancer-specific survival (BCSS) are assigned depending on the hazard ratio (HR) from the multivariable analysis. The total PEPI score assigned to each participant is the sum of the risk points derived from the primary tumor (pT) stage, regional lymph nodes (pN) stage, Ki67 level, and estrogen receptor status of the surgical specimen. A HR in the range of 1 to 2 receives one risk point; a HR in the 2 to 2.5 range, two risk points; a HR greater than 2.5, three risk points. The total risk point score for each participant is the sum of all the risk points accumulated from the four factors in the model, ranges from 0 (best possible outcome) to 12 (worst possible outcome). |
| Percentage of Participants With Total pCR Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA WT Participants | From Baseline to 16 weeks | Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition). |
| Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA MT Participants | From Baseline to 16 weeks | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA WT Participants | From Baseline to 16 weeks | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
Countries
Australia, Austria, Belgium, Brazil, Chile, Czechia, El Salvador, France, Germany, Guatemala, Hungary, Italy, Mexico, Panama, Peru, Poland, Portugal, South Korea, Spain, Switzerland, United Kingdom, United States
Participant flow
Recruitment details
The study recruited post-menopausal participants with breast cancer in 22 countries from November 2014 to March 2017.
Participants by arm
| Arm | Count |
|---|---|
| Experimental: Taselisib + Letrozole Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks. | 166 |
| Placebo Comparator: Placebo + Letrozole Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks. | 168 |
| Total | 334 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 0 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Non-compliance | 1 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Progression of disease | 0 | 2 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Reason not specified | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Total | Placebo Comparator: Placebo + Letrozole | Experimental: Taselisib + Letrozole |
|---|---|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 8.6 | 64.7 years STANDARD_DEVIATION 8.7 | 64.6 years STANDARD_DEVIATION 8.5 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 22 Participants | 11 Participants | 11 Participants |
| Race/Ethnicity, Customized Asian | 12 Participants | 6 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 84 Participants | 48 Participants | 36 Participants |
| Race/Ethnicity, Customized Missing | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 223 Participants | 109 Participants | 114 Participants |
| Race/Ethnicity, Customized Not Reported | 23 Participants | 10 Participants | 13 Participants |
| Race/Ethnicity, Customized Other | 9 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown | 4 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 283 Participants | 140 Participants | 143 Participants |
| Sex: Female, Male Female | 334 Participants | 168 Participants | 166 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 | 1 / 167 | 0 / 167 |
| other Total, other adverse events | 130 / 167 | 126 / 167 |
| serious Total, serious adverse events | 20 / 167 | 4 / 167 |
Outcome results
Primary
Percentage of Participants With Objective Response (OR) by Centrally Assessed Breast Magnetic Resonance Imaging (MRI) Via Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1
Objective response rate (ORR) was defined as proportion of participants achieving complete response (CR) or partial response (PR). As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time frame: From Baseline to 16 weeks
Population: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Taselisib + Letrozole | Percentage of Participants With Objective Response (OR) by Centrally Assessed Breast Magnetic Resonance Imaging (MRI) Via Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1 | 50.0 percentage of participants |
| Placebo Comparator: Placebo + Letrozole | Percentage of Participants With Objective Response (OR) by Centrally Assessed Breast Magnetic Resonance Imaging (MRI) Via Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1 | 39.3 percentage of participants |
p-value: 0.04995% CI: [0.11, 21.32]Cochran-Mantel-Haenszel
Primary
Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in Phosphatidylinositol-4,5-Bisphosphate 3-Kinase, Catalytic Subunit Alpha (PIK3CA) Mutant (MT) Participants
ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time frame: From Baseline to 16 weeks
Population: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Taselisib + Letrozole | Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in Phosphatidylinositol-4,5-Bisphosphate 3-Kinase, Catalytic Subunit Alpha (PIK3CA) Mutant (MT) Participants | 56.2 percentage of participants |
| Placebo Comparator: Placebo + Letrozole | Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in Phosphatidylinositol-4,5-Bisphosphate 3-Kinase, Catalytic Subunit Alpha (PIK3CA) Mutant (MT) Participants | 38.0 percentage of participants |
p-value: 0.033295% CI: [2.57, 33.81]Cochran-Mantel-Haenszel
Primary
Percentage of Participants With Total Pathologic Complete Response (Total pCR), Defined as Having pCR in Both Breast and Axilla, Using American Joint Committee on Cancer (AJCC) Staging System
Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes ( i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition).
Time frame: From Baseline to 16 weeks
Population: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Taselisib + Letrozole | Percentage of Participants With Total Pathologic Complete Response (Total pCR), Defined as Having pCR in Both Breast and Axilla, Using American Joint Committee on Cancer (AJCC) Staging System | 1.8 percentage of participants |
| Placebo Comparator: Placebo + Letrozole | Percentage of Participants With Total Pathologic Complete Response (Total pCR), Defined as Having pCR in Both Breast and Axilla, Using American Joint Committee on Cancer (AJCC) Staging System | 0.6 percentage of participants |
p-value: 0.369895% CI: [-1.12, 3.55]Fisher Exact
Primary
Percentage of Participants With Total pCR , Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA MT Participants
Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition).
Time frame: From Baseline to 16 weeks
Population: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Taselisib + Letrozole | Percentage of Participants With Total pCR , Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA MT Participants | 1.4 percentage of participants |
| Placebo Comparator: Placebo + Letrozole | Percentage of Participants With Total pCR , Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA MT Participants | 0 percentage of participants |
p-value: 0.480395% CI: [-1.3, 4.04]Fisher Exact
Secondary
Central Assessments of Changes in Ki67 Levels
Ki67 is a prognostic marker and is used to evaluate the proliferative activity of breast cancer.
Time frame: From Baseline to Week 3 and Surgery (Weeks 17-18); and Week 3 to Surgery (Weeks 17-18)
Population: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: Taselisib + Letrozole | Central Assessments of Changes in Ki67 Levels | From Baseline to Week 3 | -83.81 percentage |
| Experimental: Taselisib + Letrozole | Central Assessments of Changes in Ki67 Levels | From Baseline to Surgery | -75.58 percentage |
| Placebo Comparator: Placebo + Letrozole | Central Assessments of Changes in Ki67 Levels | From Baseline to Week 3 | -80.44 percentage |
| Placebo Comparator: Placebo + Letrozole | Central Assessments of Changes in Ki67 Levels | From Baseline to Surgery | -80.51 percentage |
Comparison: Statistical analysis for changes in Ki67 levels from Baseline to Week 3.p-value: 0.11795% CI: [0.65, 1.05]Regression, Linear
Comparison: Statistical analysis for changes in Ki67 levels from Baseline to Surgery.p-value: 0.10595% CI: [0.95, 1.65]Regression, Linear
Secondary
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. The first 28 questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting \[N/V\], constipation, and pain) and a single item (financial difficulties). The last 2 questions represented the participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement. Here, Post surgery= PS.
Time frame: Weeks 1, 5, 9, 13, 16, 4-week Post-Surgery
Population: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Fatigue: Change at Week 16 | 6.8 score on a scale | Standard Deviation 17.5 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Appetite Loss: Change at PS Visit | 5.0 score on a scale | Standard Deviation 24.9 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Financial difficulties: Change at Week 5 | -2.6 score on a scale | Standard Deviation 14.6 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Constipation: Change at PS Visit | 4.8 score on a scale | Standard Deviation 23.2 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Financial difficulties: Change at Week 9 | -2.6 score on a scale | Standard Deviation 17.9 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Global health status / QoL: Change at Week 16 | -2.2 score on a scale | Standard Deviation 18.4 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Financial difficulties: Change at Week 13 | -1.1 score on a scale | Standard Deviation 17.9 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Diarrhoea: Baseline | 5.9 score on a scale | Standard Deviation 14.9 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Financial difficulties: Change at Week 16 | -1.1 score on a scale | Standard Deviation 15.9 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Cognitive functioning: Baseline | 90.8 score on a scale | Standard Deviation 15.8 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Financial difficulties: Change at PS Visit | 1.9 score on a scale | Standard Deviation 20 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Diarrhoea: Change at Week 5 | 6.7 score on a scale | Standard Deviation 21.7 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Global health status / QoL: Baseline | 75.3 score on a scale | Standard Deviation 19.7 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Appetite Loss: Baseline | 6.2 score on a scale | Standard Deviation 16.4 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Global health status / QoL: Change at Week 5 | 1.5 score on a scale | Standard Deviation 15.2 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Diarrhoea: Change at Week 9 | 6.4 score on a scale | Standard Deviation 24.3 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Global health status / QoL: Change at Week 9 | -1.1 score on a scale | Standard Deviation 15.9 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Cognitive functioning: Change at Week 5 | 0.4 score on a scale | Standard Deviation 12.8 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Global health status / QoL: Change at Week 13 | -2.4 score on a scale | Standard Deviation 19.5 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Diarrhoea: Change at Week 13 | 7.9 score on a scale | Standard Deviation 22.3 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Financial difficulties: Baseline | 9.0 score on a scale | Standard Deviation 20.9 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Global health status / QoL: Change at PS Visit | -5.9 score on a scale | Standard Deviation 19.7 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Diarrhoea: Change at Week 16 | 8.4 score on a scale | Standard Deviation 23.1 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Insomnia: Baseline | 23.0 score on a scale | Standard Deviation 27.1 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Cognitive functioning: Change at Week 9 | -1.1 score on a scale | Standard Deviation 14.4 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Insomnia: Change at Week 5 | -2.4 score on a scale | Standard Deviation 24.1 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Diarrhoea: Change at PS Visit | 0.2 score on a scale | Standard Deviation 17.7 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Insomnia: Change at Week 9 | -1.8 score on a scale | Standard Deviation 24.9 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Insomnia: Change at Week 13 | -1.1 score on a scale | Standard Deviation 27.7 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Appetite Loss: Change at Week 5 | 3.0 score on a scale | Standard Deviation 18.4 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Insomnia: Change at Week 16 | -0.7 score on a scale | Standard Deviation 26.1 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Dyspnoea: Baseline | 7.4 score on a scale | Standard Deviation 15.8 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Insomnia: Change at PS Visit | -1.4 score on a scale | Standard Deviation 26.8 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Cognitive functioning: Change at Week 13 | -3.4 score on a scale | Standard Deviation 15.8 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Nausea and vomiting: Baseline | 1.9 score on a scale | Standard Deviation 7.5 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Dyspnoea: Change at Week 5 | -0.2 score on a scale | Standard Deviation 14 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Nausea and vomiting: Change at Week 5 | 3.7 score on a scale | Standard Deviation 11.3 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Physical functioning: Change at Week 5 | 0.5 score on a scale | Standard Deviation 9.6 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Nausea and vomiting: Change at Week 9 | 3.4 score on a scale | Standard Deviation 10.9 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Dyspnoea: Change at Week 9 | 2.0 score on a scale | Standard Deviation 17.4 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Nausea and vomiting: Change at Week 13 | 3.7 score on a scale | Standard Deviation 12.9 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Cognitive functioning: Change at Week 16 | -4.2 score on a scale | Standard Deviation 15.2 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Nausea and vomiting: Change at Week 16 | 2.5 score on a scale | Standard Deviation 14 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Dyspnoea: Change at Week 13 | 3.5 score on a scale | Standard Deviation 21.1 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Nausea and vomiting: Change at PS Visit | 2.1 score on a scale | Standard Deviation 14.8 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Appetite Loss: Change at Week 9 | 5.3 score on a scale | Standard Deviation 21.4 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Pain: Baseline | 13.1 score on a scale | Standard Deviation 20.4 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Dyspnoea: Change at Week 16 | 3.4 score on a scale | Standard Deviation 20.2 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Pain: Change at Week 5 | -0.6 score on a scale | Standard Deviation 18.8 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Cognitive functioning: Change at PS Visit | -3.1 score on a scale | Standard Deviation 18.9 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Pain: Change at Week 9 | -1.8 score on a scale | Standard Deviation 16.5 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Dyspnoea: Change at PS Visit | 3.1 score on a scale | Standard Deviation 24.8 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Pain: Change at Week 13 | -1.4 score on a scale | Standard Deviation 18.4 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Physical functioning: Change at PS Visit | -5.2 score on a scale | Standard Deviation 16 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Pain: Change at Week 16 | -0.9 score on a scale | Standard Deviation 19.1 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Emotional functioning: Baseline | 77.0 score on a scale | Standard Deviation 20.4 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Pain: Change at PS Visit | 11.1 score on a scale | Standard Deviation 26 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Constipation: Baseline | 6.8 score on a scale | Standard Deviation 15.9 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Physical functioning: Baseline | 89.6 score on a scale | Standard Deviation 13.7 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Emotional functioning: Change at Week 5 | 4.2 score on a scale | Standard Deviation 15.2 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Appetite Loss: Change at Week 13 | 5.5 score on a scale | Standard Deviation 23.8 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Physical functioning: Change at Week 9 | 0.2 score on a scale | Standard Deviation 10.1 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Emotional functioning: Change at Week 9 | 3.8 score on a scale | Standard Deviation 14.7 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Physical functioning: Change at Week 13 | -0.3 score on a scale | Standard Deviation 12.4 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Constipation: Change at Week 5 | 0.0 score on a scale | Standard Deviation 16.1 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Physical functioning: Change at Week 16 | -0.5 score on a scale | Standard Deviation 10.9 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Emotional functioning: Change at Week 13 | 2.5 score on a scale | Standard Deviation 15.2 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Fatigue: Change at PS Visit | 12.3 score on a scale | Standard Deviation 19.5 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Role functioning:Change at Week 5 | 1.3 score on a scale | Standard Deviation 14.3 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Emotional functioning: Change at Week 16 | 1.0 score on a scale | Standard Deviation 17 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Role functioning:Change at Week 9 | -0.2 score on a scale | Standard Deviation 12.8 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Constipation: Change at Week 9 | 0.2 score on a scale | Standard Deviation 17 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Role functioning:Change at Week 13 | -2.3 score on a scale | Standard Deviation 17.4 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Emotional functioning: Change at PS Visit | -0.8 score on a scale | Standard Deviation 19 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Role functioning:Change at Week 16 | -4.6 score on a scale | Standard Deviation 16.3 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Fatigue: Baseline | 14.8 score on a scale | Standard Deviation 18.7 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Role functioning:Change at PS Visit | -15.1 score on a scale | Standard Deviation 24.7 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Appetite Loss: Change at Week 16 | 6.8 score on a scale | Standard Deviation 24.1 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Social functioning: Baseline | 91.2 score on a scale | Standard Deviation 17.6 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Fatigue: Change at Week 5 | 4.7 score on a scale | Standard Deviation 13.9 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Social functioning: Change at Week 5 | 3.1 score on a scale | Standard Deviation 12.8 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Constipation: Change at Week 13 | -0.4 score on a scale | Standard Deviation 18.5 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Social functioning: Change at Week 9 | 2.0 score on a scale | Standard Deviation 13.4 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Fatigue: Change at Week 9 | 5.0 score on a scale | Standard Deviation 15.9 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Social functioning: Change at Week 13 | 0.0 score on a scale | Standard Deviation 13.7 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Role functioning: Baseline | 90.7 score on a scale | Standard Deviation 20.1 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Social functioning: Change at Week 16 | -0.5 score on a scale | Standard Deviation 13.7 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Fatigue: Change at Week 13 | 7.9 score on a scale | Standard Deviation 18.1 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Social functioning: Change at PS Visit | -6.4 score on a scale | Standard Deviation 20.3 |
| Experimental: Taselisib + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Constipation: Change at Week 16 | -1.1 score on a scale | Standard Deviation 17.2 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Social functioning: Change at PS Visit | -10.1 score on a scale | Standard Deviation 24.2 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Financial difficulties: Baseline | 10.0 score on a scale | Standard Deviation 20.4 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Insomnia: Change at Week 9 | -0.6 score on a scale | Standard Deviation 26.9 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Physical functioning: Change at PS Visit | -7.5 score on a scale | Standard Deviation 15.7 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Emotional functioning: Change at PS Visit | -3.6 score on a scale | Standard Deviation 20.9 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Appetite Loss: Baseline | 5.9 score on a scale | Standard Deviation 14.2 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Appetite Loss: Change at Week 5 | 1.9 score on a scale | Standard Deviation 18.8 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Appetite Loss: Change at Week 9 | 3.0 score on a scale | Standard Deviation 17.8 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Appetite Loss: Change at Week 13 | 2.1 score on a scale | Standard Deviation 16.3 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Appetite Loss: Change at Week 16 | 0.9 score on a scale | Standard Deviation 16.3 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Appetite Loss: Change at PS Visit | 5.0 score on a scale | Standard Deviation 23.3 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Cognitive functioning: Baseline | 90.9 score on a scale | Standard Deviation 16.6 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Cognitive functioning: Change at Week 5 | -2.5 score on a scale | Standard Deviation 12.3 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Cognitive functioning: Change at Week 9 | -4.2 score on a scale | Standard Deviation 14.7 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Cognitive functioning: Change at Week 13 | -5.1 score on a scale | Standard Deviation 15.7 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Cognitive functioning: Change at Week 16 | -4.1 score on a scale | Standard Deviation 17.5 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Cognitive functioning: Change at PS Visit | -5.4 score on a scale | Standard Deviation 16.8 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Constipation: Baseline | 8.3 score on a scale | Standard Deviation 18.2 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Constipation: Change at Week 5 | 3.1 score on a scale | Standard Deviation 22.1 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Constipation: Change at Week 9 | 0.2 score on a scale | Standard Deviation 18.6 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Constipation: Change at Week 13 | -0.6 score on a scale | Standard Deviation 19.5 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Constipation: Change at Week 16 | 1.6 score on a scale | Standard Deviation 20.3 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Constipation: Change at PS Visit | 1.1 score on a scale | Standard Deviation 16.9 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Diarrhoea: Baseline | 4.3 score on a scale | Standard Deviation 11.8 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Diarrhoea: Change at Week 5 | -0.2 score on a scale | Standard Deviation 13.4 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Diarrhoea: Change at Week 9 | 0.8 score on a scale | Standard Deviation 15.1 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Diarrhoea: Change at Week 13 | -0.4 score on a scale | Standard Deviation 14.7 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Diarrhoea: Change at Week 16 | 0.2 score on a scale | Standard Deviation 16.4 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Diarrhoea: Change at PS Visit | -0.9 score on a scale | Standard Deviation 15.7 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Dyspnoea: Baseline | 8.5 score on a scale | Standard Deviation 17.5 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Dyspnoea: Change at Week 5 | 0.6 score on a scale | Standard Deviation 18.1 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Dyspnoea: Change at Week 9 | 1.9 score on a scale | Standard Deviation 19.9 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Dyspnoea: Change at Week 13 | 1.7 score on a scale | Standard Deviation 22.3 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Dyspnoea: Change at Week 16 | 2.6 score on a scale | Standard Deviation 22.6 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Dyspnoea: Change at PS Visit | 2.1 score on a scale | Standard Deviation 21.5 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Emotional functioning: Baseline | 78.2 score on a scale | Standard Deviation 19.9 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Emotional functioning: Change at Week 5 | 2.4 score on a scale | Standard Deviation 17 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Emotional functioning: Change at Week 9 | 1.3 score on a scale | Standard Deviation 20.7 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Emotional functioning: Change at Week 13 | -1.4 score on a scale | Standard Deviation 18.6 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Emotional functioning: Change at Week 16 | -3.5 score on a scale | Standard Deviation 20.2 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Fatigue: Baseline | 15.6 score on a scale | Standard Deviation 18.5 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Fatigue: Change at Week 5 | 4.9 score on a scale | Standard Deviation 17.9 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Fatigue: Change at Week 9 | 7.5 score on a scale | Standard Deviation 20.3 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Fatigue: Change at Week 13 | 8.8 score on a scale | Standard Deviation 21.4 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Fatigue: Change at PS Visit | 12.4 score on a scale | Standard Deviation 22.6 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Financial difficulties: Change at Week 5 | -0.4 score on a scale | Standard Deviation 20.2 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Financial difficulties: Change at Week 9 | 0.7 score on a scale | Standard Deviation 20.4 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Financial difficulties: Change at Week 13 | 0.0 score on a scale | Standard Deviation 19.9 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Financial difficulties: Change at Week 16 | 2.1 score on a scale | Standard Deviation 24.4 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Financial difficulties: Change at PS Visit | 3.8 score on a scale | Standard Deviation 23.6 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Global health status / QoL: Baseline | 74.6 score on a scale | Standard Deviation 21.2 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Global health status / QoL: Change at Week 5 | -1.1 score on a scale | Standard Deviation 18.5 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Global health status / QoL: Change at Week 9 | -3.2 score on a scale | Standard Deviation 22.7 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Global health status / QoL: Change at Week 13 | -3.7 score on a scale | Standard Deviation 20.7 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Global health status / QoL: Change at Week 16 | -2.9 score on a scale | Standard Deviation 22.6 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Global health status / QoL: Change at PS Visit | -7.0 score on a scale | Standard Deviation 22.2 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Insomnia: Baseline | 22.4 score on a scale | Standard Deviation 28.1 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Insomnia: Change at Week 5 | -0.4 score on a scale | Standard Deviation 27.6 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Insomnia: Change at Week 13 | 2.1 score on a scale | Standard Deviation 29.5 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Insomnia: Change at Week 16 | -2.2 score on a scale | Standard Deviation 27.6 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Insomnia: Change at PS Visit | 3.2 score on a scale | Standard Deviation 34.4 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Nausea and vomiting: Baseline | 1.6 score on a scale | Standard Deviation 6.2 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Nausea and vomiting: Change at Week 5 | 1.9 score on a scale | Standard Deviation 9.9 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Nausea and vomiting: Change at Week 9 | 1.7 score on a scale | Standard Deviation 10.3 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Nausea and vomiting: Change at Week 13 | 0.7 score on a scale | Standard Deviation 8.5 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Nausea and vomiting: Change at Week 16 | 0.6 score on a scale | Standard Deviation 8 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Nausea and vomiting: Change at PS Visit | 1.0 score on a scale | Standard Deviation 8.6 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Pain: Baseline | 12.3 score on a scale | Standard Deviation 19.6 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Pain: Change at Week 5 | 2.6 score on a scale | Standard Deviation 17.5 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Pain: Change at Week 9 | 3.8 score on a scale | Standard Deviation 22.9 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Pain: Change at Week 13 | 4.7 score on a scale | Standard Deviation 23.4 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Pain: Change at Week 16 | 1.8 score on a scale | Standard Deviation 22 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Pain: Change at PS Visit | 13.8 score on a scale | Standard Deviation 26.6 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Physical functioning: Baseline | 90.8 score on a scale | Standard Deviation 13.4 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Physical functioning: Change at Week 5 | -1.2 score on a scale | Standard Deviation 11.5 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Physical functioning: Change at Week 9 | -2.0 score on a scale | Standard Deviation 13.1 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Physical functioning: Change at Week 13 | -1.9 score on a scale | Standard Deviation 14 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Physical functioning: Change at Week 16 | -3.4 score on a scale | Standard Deviation 15.1 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Role functioning: Baseline | 93.1 score on a scale | Standard Deviation 16.5 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Role functioning:Change at Week 5 | -2.5 score on a scale | Standard Deviation 17.1 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Role functioning:Change at Week 9 | -4.9 score on a scale | Standard Deviation 18.9 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Role functioning:Change at Week 13 | -5.6 score on a scale | Standard Deviation 19.8 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Role functioning:Change at Week 16 | -4.4 score on a scale | Standard Deviation 18.9 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Role functioning:Change at PS Visit | -20.1 score on a scale | Standard Deviation 28.1 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Social functioning: Baseline | 94.9 score on a scale | Standard Deviation 14.3 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Social functioning: Change at Week 5 | -2.0 score on a scale | Standard Deviation 15.7 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Social functioning: Change at Week 9 | -4.0 score on a scale | Standard Deviation 18.1 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Social functioning: Change at Week 13 | -4.0 score on a scale | Standard Deviation 19 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Social functioning: Change at Week 16 | -3.1 score on a scale | Standard Deviation 19.3 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | Fatigue: Change at Week 16 | 8.0 score on a scale | Standard Deviation 20.4 |
Secondary
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and four symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores were averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL. Here, Post surgery= PS.
Time frame: Weeks 1, 5, 9, 13, 16, 4-week Post-Surgery
Population: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Systematic therapy side effects: Change at Week 16 | 7.5 score on a scale | Standard Deviation 12.9 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Breast symptoms: Change at PS Visit | 6.6 score on a scale | Standard Deviation 17.9 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Upset by hair loss: Change at Week 13 | 16.7 score on a scale | Standard Deviation 36 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Future perspective: Baseline | 57.7 score on a scale | Standard Deviation 31 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Body image: Baseline | 91.8 score on a scale | Standard Deviation 15.7 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Future perspective: Change at Week 5 | 6.5 score on a scale | Standard Deviation 26.7 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual enjoyment: Change at Week 9 | 8.3 score on a scale | Standard Deviation 23.6 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Future perspective: Change at Week 13 | 7.7 score on a scale | Standard Deviation 28.4 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Body image: Change at Week 5 | 2.8 score on a scale | Standard Deviation 8.8 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Future perspective: Change at Week 16 | 10.2 score on a scale | Standard Deviation 26.1 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Breast symptoms: Change at Week 13 | 5.8 score on a scale | Standard Deviation 16 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual enjoyment: Change at Week 13 | 6.1 score on a scale | Standard Deviation 19.5 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual functioning: Change at Week 5 | 1.2 score on a scale | Standard Deviation 13.6 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual enjoyment: Change at Week 16 | 9.8 score on a scale | Standard Deviation 19.3 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Body image: Change at Week 9 | 1.2 score on a scale | Standard Deviation 9.8 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual enjoyment: Change at PS Visit | 14.3 score on a scale | Standard Deviation 27 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Future perspective: Change at Week 9 | 10.2 score on a scale | Standard Deviation 25 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual functioning: Baseline | 81.2 score on a scale | Standard Deviation 23.4 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Body image: Change at Week 13 | 1.2 score on a scale | Standard Deviation 11.6 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual functioning: Change at Week 9 | 1.3 score on a scale | Standard Deviation 14.5 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Body image: Change at Week 16 | 0.1 score on a scale | Standard Deviation 10.8 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual functioning: Change at Week 16 | 4.8 score on a scale | Standard Deviation 15.9 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual functioning: Change at Week 13 | 4.1 score on a scale | Standard Deviation 16.1 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual functioning: Change at PS Visit | 9.6 score on a scale | Standard Deviation 19.2 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Systematic therapy side effects: Change at Week 5 | 4.3 score on a scale | Standard Deviation 10 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Systematic therapy side effects: Change at Week 9 | 6.7 score on a scale | Standard Deviation 10.8 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Body image: Change at PS Visit | -6.5 score on a scale | Standard Deviation 22.3 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Systematic therapy side effects: Change at Week 13 | 7.3 score on a scale | Standard Deviation 11 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual enjoyment: Baseline | 41.7 score on a scale | Standard Deviation 22.3 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Systematic therapy side effects:Change at PS Visit | 7.0 score on a scale | Standard Deviation 12 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Breast symptoms: Baseline | 5.3 score on a scale | Standard Deviation 9.8 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Upset by hair loss: Baseline | 24.6 score on a scale | Standard Deviation 26.9 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Systematic therapy side effects: Baseline | 8.7 score on a scale | Standard Deviation 10.8 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Upset by hair loss: Change at Week 5 | 11.1 score on a scale | Standard Deviation 32.8 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Breast symptoms: Change at Week 5 | 2.3 score on a scale | Standard Deviation 14.6 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Upset by hair loss: Change at Week 9 | 9.1 score on a scale | Standard Deviation 44.9 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Breast symptoms: Change at Week 16 | 7.9 score on a scale | Standard Deviation 18.6 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Breast symptoms: Change at Week 9 | 4.5 score on a scale | Standard Deviation 15.1 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Upset by hair loss: Change at Week 16 | 21.2 score on a scale | Standard Deviation 34.2 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual enjoyment: Change at Week 5 | 3.3 score on a scale | Standard Deviation 18.2 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Upset by hair loss: Change at PS Visit | 30.8 score on a scale | Standard Deviation 37.2 |
| Experimental: Taselisib + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Future perspective: Change at PS Visit | 6.5 score on a scale | Standard Deviation 29.7 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual enjoyment: Change at Week 9 | 10.6 score on a scale | Standard Deviation 23.9 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Future perspective: Change at Week 5 | 9.3 score on a scale | Standard Deviation 28.1 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Future perspective: Change at Week 16 | 5.1 score on a scale | Standard Deviation 29.2 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Future perspective: Change at PS Visit | 3.4 score on a scale | Standard Deviation 34.8 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual enjoyment: Baseline | 47.1 score on a scale | Standard Deviation 28.9 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual enjoyment: Change at Week 5 | 11.1 score on a scale | Standard Deviation 23.4 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual functioning: Change at Week 5 | 1.0 score on a scale | Standard Deviation 15 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual functioning: Change at PS Visit | 4.1 score on a scale | Standard Deviation 21.8 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Systematic therapy side effects: Baseline | 9.5 score on a scale | Standard Deviation 11.5 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Systematic therapy side effects: Change at Week 5 | 3.9 score on a scale | Standard Deviation 10.5 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Systematic therapy side effects: Change at Week 13 | 6.2 score on a scale | Standard Deviation 13.1 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Body image: Baseline | 94.0 score on a scale | Standard Deviation 14.6 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Body image: Change at Week 5 | 0.6 score on a scale | Standard Deviation 11.4 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Body image: Change at Week 9 | -0.2 score on a scale | Standard Deviation 10.3 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Body image: Change at Week 13 | -1.6 score on a scale | Standard Deviation 13.8 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Body image: Change at Week 16 | -1.2 score on a scale | Standard Deviation 12.8 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Body image: Change at PS Visit | -8.3 score on a scale | Standard Deviation 19.2 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Breast symptoms: Baseline | 6.9 score on a scale | Standard Deviation 12.7 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Breast symptoms: Change at Week 5 | 1.0 score on a scale | Standard Deviation 13 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Breast symptoms: Change at Week 9 | 1.8 score on a scale | Standard Deviation 11.7 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Breast symptoms: Change at Week 13 | 2.3 score on a scale | Standard Deviation 13.3 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Breast symptoms: Change at Week 16 | 3.9 score on a scale | Standard Deviation 14.9 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Breast symptoms: Change at PS Visit | 4.3 score on a scale | Standard Deviation 14.2 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Future perspective: Baseline | 58.7 score on a scale | Standard Deviation 29.9 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Future perspective: Change at Week 9 | 9.7 score on a scale | Standard Deviation 26.6 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Future perspective: Change at Week 13 | 4.4 score on a scale | Standard Deviation 29.1 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual enjoyment: Change at Week 13 | 1.6 score on a scale | Standard Deviation 22.3 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual enjoyment: Change at Week 16 | 7.6 score on a scale | Standard Deviation 22.8 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual enjoyment: Change at PS Visit | 2.2 score on a scale | Standard Deviation 23.5 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual functioning: Baseline | 85.1 score on a scale | Standard Deviation 20.2 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual functioning: Change at Week 9 | 0.3 score on a scale | Standard Deviation 16.5 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual functioning: Change at Week 13 | 1.6 score on a scale | Standard Deviation 17.7 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Sexual functioning: Change at Week 16 | 1.1 score on a scale | Standard Deviation 18.1 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Systematic therapy side effects: Change at Week 9 | 5.9 score on a scale | Standard Deviation 12.1 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Systematic therapy side effects: Change at Week 16 | 7.1 score on a scale | Standard Deviation 12.6 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Systematic therapy side effects:Change at PS Visit | 5.9 score on a scale | Standard Deviation 12.1 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Upset by hair loss: Baseline | 35.2 score on a scale | Standard Deviation 31.3 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Upset by hair loss: Change at Week 5 | -3.3 score on a scale | Standard Deviation 18.9 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Upset by hair loss: Change at Week 9 | -9.1 score on a scale | Standard Deviation 26.2 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Upset by hair loss: Change at Week 13 | -3.0 score on a scale | Standard Deviation 34.8 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Upset by hair loss: Change at Week 16 | -7.1 score on a scale | Standard Deviation 23.3 |
| Placebo Comparator: Placebo + Letrozole | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | Upset by hair loss: Change at PS Visit | -2.6 score on a scale | Standard Deviation 34.6 |
Secondary
Percentage of Participants With Adverse Events
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Baseline up to 22 weeks
Population: The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Taselisib + Letrozole | Percentage of Participants With Adverse Events | 91.0 percentage of participants |
| Placebo Comparator: Placebo + Letrozole | Percentage of Participants With Adverse Events | 83.2 percentage of participants |
Secondary
Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA MT Participants
ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time frame: From Baseline to 16 weeks
Population: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Taselisib + Letrozole | Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA MT Participants | 61.6 percentage of participants |
| Placebo Comparator: Placebo + Letrozole | Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA MT Participants | 40.5 percentage of participants |
p-value: 0.011595% CI: [5.59, 36.68]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA WT Participants
ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time frame: From Baseline to 16 weeks
Population: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Taselisib + Letrozole | Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA WT Participants | 54.3 percentage of participants |
| Placebo Comparator: Placebo + Letrozole | Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA WT Participants | 51.7 percentage of participants |
p-value: 0.792895% CI: [-11.88, 17.2]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in PIK3CA Wildtype (WT) Participants
ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time frame: From Baseline to 16 weeks
Population: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Taselisib + Letrozole | Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in PIK3CA Wildtype (WT) Participants | 45.7 percentage of participants |
| Placebo Comparator: Placebo + Letrozole | Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in PIK3CA Wildtype (WT) Participants | 40.4 percentage of participants |
p-value: 0.501795% CI: [-9.2, 19.61]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA MT Participants
ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time frame: From Baseline to 16 weeks
Population: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Taselisib + Letrozole | Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA MT Participants | 74.0 percentage of participants |
| Placebo Comparator: Placebo + Letrozole | Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA MT Participants | 63.3 percentage of participants |
p-value: 0.155495% CI: [-3.96, 25.32]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA WT Participants
ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time frame: From Baseline to 16 weeks
Population: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Taselisib + Letrozole | Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA WT Participants | 62.0 percentage of participants |
| Placebo Comparator: Placebo + Letrozole | Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA WT Participants | 59.6 percentage of participants |
p-value: 0.78795% CI: [-11.82, 16.63]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA MT Participants
ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time frame: From Baseline to 16 weeks
Population: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Taselisib + Letrozole | Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA MT Participants | 41.1 percentage of participants |
| Placebo Comparator: Placebo + Letrozole | Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA MT Participants | 31.6 percentage of participants |
p-value: 0.265995% CI: [-5.8, 24.7]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA WT Participants
ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time frame: From Baseline to 16 weeks
Population: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Taselisib + Letrozole | Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA WT Participants | 40.2 percentage of participants |
| Placebo Comparator: Placebo + Letrozole | Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA WT Participants | 32.6 percentage of participants |
p-value: 0.329995% CI: [-6.34, 21.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Total pCR Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA WT Participants
Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition).
Time frame: From Baseline to 16 weeks
Population: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Taselisib + Letrozole | Percentage of Participants With Total pCR Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA WT Participants | 2.2 percentage of participants |
| Placebo Comparator: Placebo + Letrozole | Percentage of Participants With Total pCR Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA WT Participants | 1.1 percentage of participants |
p-value: 195% CI: [-2.65, 4.75]Fisher Exact
Secondary
Percent Change From Baseline to Surgery in Enhancing Tumor Volume as Measured by Breast MRI
Time frame: From Baseline to Surgery (Weeks 17-18)
Population: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Taselisib + Letrozole | Percent Change From Baseline to Surgery in Enhancing Tumor Volume as Measured by Breast MRI | -70.60 percent change |
| Placebo Comparator: Placebo + Letrozole | Percent Change From Baseline to Surgery in Enhancing Tumor Volume as Measured by Breast MRI | -57.28 percent change |
p-value: 0.00295% CI: [-21.67, -4.96]Regression, Linear
Secondary
Preoperative Endocrine Prognostic Index (PEPI ) Score
To obtain the PEPI score, risk points for relapse-free survival (RFS) and breast cancer-specific survival (BCSS) are assigned depending on the hazard ratio (HR) from the multivariable analysis. The total PEPI score assigned to each participant is the sum of the risk points derived from the primary tumor (pT) stage, regional lymph nodes (pN) stage, Ki67 level, and estrogen receptor status of the surgical specimen. A HR in the range of 1 to 2 receives one risk point; a HR in the 2 to 2.5 range, two risk points; a HR greater than 2.5, three risk points. The total risk point score for each participant is the sum of all the risk points accumulated from the four factors in the model, ranges from 0 (best possible outcome) to 12 (worst possible outcome).
Time frame: Week 16
Population: Data were not collected for this outcome measure.