Trial Outcomes & Findings for A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy (NCT NCT02340221)

Last Updated: 2022-07-12

Results Overview

PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

631 participants

Primary outcome timeframe

From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)

Results posted on

2022-07-12

Participant Flow

This study was conducted at 155 centers in 28 countries.

The study enrolled postmenopausal women with estrogen receptor-positive and human epidermal receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who had disease recurrence or progression during or after aromatase inhibitor therapy. Randomization was stratified by three factors: 1) visceral versus non-visceral disease, 2) sensitivity versus non-sensitivity to most recent endocrine therapy, and 3) geographical region.

Participant milestones

Participant milestones
Measure	Placebo+Fulvestrant Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Overall Study STARTED	214	417
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	214	417

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo+Fulvestrant Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Overall Study Death	100	197
Overall Study Withdrawal by Participant	24	37
Overall Study Lost to Follow-up	4	15
Overall Study Reason Not Specified	85	165
Overall Study Study Terminated by Sponsor	1	3

Baseline Characteristics

A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo+Fulvestrant n=214 Participants Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant n=417 Participants Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Total n=631 Participants Total of all reporting groups
Age, Continuous	60.7 years STANDARD_DEVIATION 10.0 • n=5 Participants	60.1 years STANDARD_DEVIATION 9.9 • n=7 Participants	60.3 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	214 Participants n=5 Participants	417 Participants n=7 Participants	631 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	166 Participants n=5 Participants	334 Participants n=7 Participants	500 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	26 Participants n=5 Participants	48 Participants n=7 Participants	74 Participants n=5 Participants
Race/Ethnicity, Customized Not Stated	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	14 Participants n=5 Participants	30 Participants n=7 Participants	44 Participants n=5 Participants
Race/Ethnicity, Customized White	147 Participants n=5 Participants	285 Participants n=7 Participants	432 Participants n=5 Participants
Race/Ethnicity, Customized Asian	38 Participants n=5 Participants	72 Participants n=7 Participants	110 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	13 Participants n=5 Participants	24 Participants n=7 Participants	37 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)

Population: Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.

Outcome measures

Outcome measures
Measure	Placebo+Fulvestrant n=176 Participants Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant n=340 Participants Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) at Primary Analysis	5.39 months Interval 3.68 to 7.29	7.43 months Interval 7.26 to 9.07

PRIMARY outcome

Timeframe: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)

Population: Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.

PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.

Outcome measures

Outcome measures
Measure	Placebo+Fulvestrant n=176 Participants Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant n=340 Participants Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
PFS as Assessed by Investigator Using RECIST v1.1 at Final Analysis	5.55 months Interval 3.75 to 7.33	8.05 months Interval 7.33 to 9.1

SECONDARY outcome

Timeframe: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)

Population: Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment.

PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).

Outcome measures

Outcome measures
Measure	Placebo+Fulvestrant n=134 Participants Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant n=264 Participants Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1 at Primary Analysis	11.9 percentage of participants Interval 7.1 to 18.3	28.0 percentage of participants Interval 22.7 to 33.8

SECONDARY outcome

Timeframe: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)

Population: Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment.

Outcome measures

Outcome measures
Measure	Placebo+Fulvestrant n=134 Participants Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant n=264 Participants Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Percentage of Participants With Objective Response (PR Plus CR), as Assessed Using RECIST v.1.1 at Final Analysis	13.4 percentage of participants Interval 8.2 to 20.2	31.1 percentage of participants Interval 25.5 to 36.8

SECONDARY outcome

Timeframe: From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)

Population: Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.

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

Outcome measures

Outcome measures
Measure	Placebo+Fulvestrant n=176 Participants Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant n=340 Participants Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Overall Survival (OS) at Primary Analysis	23.56 months Interval 18.0 to Upper limit of confidence interval was not estimable due to the low number of participants with events.	26.81 months Interval 21.29 to Upper limit of confidence interval was not estimable due to the low number of participants with events.

SECONDARY outcome

Timeframe: From randomization up to death from any cause (up to approximately 6.2 years)

Population: Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.

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

Outcome measures

Outcome measures
Measure	Placebo+Fulvestrant n=176 Participants Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant n=340 Participants Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
OS at Final Analysis	27.93 months Interval 24.38 to Upper limit of confidence interval was not estimable due to the low number of participants with events.	27.79 months Interval 24.25 to 33.35

SECONDARY outcome

Timeframe: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)

Population: Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment.

Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (\>/=) 24 weeks since randomization. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.

Outcome measures

Outcome measures
Measure	Placebo+Fulvestrant n=134 Participants Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant n=264 Participants Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Primary Analysis	37.3 percentage of participants Interval 29.1 to 45.7	51.5 percentage of participants Interval 45.3 to 57.7

SECONDARY outcome

Timeframe: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)

Population: Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment.

Outcome measures

Outcome measures
Measure	Placebo+Fulvestrant n=134 Participants Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant n=264 Participants Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Final Analysis	45.5 percentage of participants Interval 37.2 to 54.3	59.5 percentage of participants Interval 53.6 to 65.4

SECONDARY outcome

Timeframe: Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)

Population: Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment. Data are reported for participants with responses.

Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.

Outcome measures

Outcome measures
Measure	Placebo+Fulvestrant n=16 Participants Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant n=74 Participants Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Primary Analysis	7.23 months Interval 6.51 to Upper limit of confidence interval was not estimable due to the low number of participants with events.	8.74 months Interval 5.72 to 11.24

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Placebo+Fulvestrant n=18 Participants Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant n=82 Participants Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Final Analysis	7.39 months Interval 4.67 to 23.95	8.97 months Interval 7.36 to 12.91

SECONDARY outcome

Timeframe: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)

Population: Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.

PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.

Outcome measures

Outcome measures
Measure	Placebo+Fulvestrant n=176 Participants Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant n=340 Participants Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1 at Primary Analysis	5.39 months Interval 3.68 to 9.23	8.97 months Interval 7.39 to 9.49

SECONDARY outcome

Timeframe: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)

Population: Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.

Outcome measures

Outcome measures
Measure	Placebo+Fulvestrant n=176 Participants Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant n=340 Participants Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
PFS as Assessed by BICR Using RECIST v1.1 at Final Analysis	5.55 months Interval 3.68 to 9.3	9.20 months Interval 8.15 to 10.87

SECONDARY outcome

Timeframe: From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years.

Population: The safety-evaluable population included all randomized participants who received at least one dose of taselisib or placebo or fulvestrant.

An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.

Outcome measures

Outcome measures
Measure	Placebo+Fulvestrant n=213 Participants Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant n=416 Participants Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Percentage of Participants With Adverse Events at Primary Analysis	89.7 percentage of participants	95.4 percentage of participants

SECONDARY outcome

Timeframe: From randomization up to approximately 6.2 years

Population: The safety-evaluable population included all randomized participants who received at least one dose of taselisib or placebo or fulvestrant.

An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.

Outcome measures

Outcome measures
Measure	Placebo+Fulvestrant n=213 Participants Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant n=416 Participants Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Percentage of Participants With Adverse Events at Final Analysis	91.1 percentage of participants	97.1 percentage of participants

SECONDARY outcome

Timeframe: 1 to 4 hours (hrs) post-dose on Cycle (C) 1, Day (D) 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1 (each cycle=28 days)

Population: The Pharmacokinetic (PK) population included all participants who received at least one dose of taselisib and provided valid (adequately documented dose time and PK sample time) PK assessments.

Outcome measures

Outcome measures
Measure	Placebo+Fulvestrant n=417 Participants Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Maximum Observed Plasma Concentration (Cmax) of Taselisib C1D1	18.2 ng/mL Standard Deviation 14.6	—
Maximum Observed Plasma Concentration (Cmax) of Taselisib C2D1	66.6 ng/mL Standard Deviation 35.2	—

SECONDARY outcome

Timeframe: 1 to 4 hrs post-dose on Cycle 1, Day 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1; 0 to 3 hrs pre-dose on Cycle 6, Day 1 (each cycle=28 days)

Population: The PK population included all participants who received at least one dose of taselisib and provided valid (adequately documented dose time and PK sample time) PK assessments.

Outcome measures

Outcome measures
Measure	Placebo+Fulvestrant n=417 Participants Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Minimum Observed Plasma Concentration (Cmin) of Taselisib C2D1	42.8 ng/mL Standard Deviation 26.6	—
Minimum Observed Plasma Concentration (Cmin) of Taselisib C6D1	35.3 ng/mL Standard Deviation 31.5	—

SECONDARY outcome

Timeframe: Baseline, C2D1 up to C7D1 (each cycle=28 days)

Population: Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment. Data are reported for evaluable participants.

The EORTC QLQ-C30 consists of 30 questions that comprise aspects of participant's functioning assessment (physical, emotional, role, cognitive, and social); symptom scales (fatigue; nausea, vomiting, and pain; the global health/quality of life \[QoL\]); and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties), within a recall period of "the past week." Most questions used a 4-point scale (1=Not at all to 4=Very much; two questions used a 7-point scale (1=Very poor to 7=Excellent). Scores were averaged and transformed to a 0-100 scale; a higher score for Global Qol/functional scales=better level of functioning; a higher score for symptom scale=greater degree of symptoms.

Outcome measures

Outcome measures
Measure	Placebo+Fulvestrant n=176 Participants Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant n=340 Participants Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Fatigue: Change at C4D1	-0.2 score on a scale Standard Deviation 19.1	2.4 score on a scale Standard Deviation 21.9
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Financial Difficulties: Baseline	18.5 score on a scale Standard Deviation 25.8	19.2 score on a scale Standard Deviation 27.1
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Financial Difficulties: Change at C3D1	-0.9 score on a scale Standard Deviation 24.9	-1.6 score on a scale Standard Deviation 24.4
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Financial Difficulties: Change at C4D1	0.7 score on a scale Standard Deviation 25.1	-0.3 score on a scale Standard Deviation 23.7
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Insomnia: Change at C5D1	-0.4 score on a scale Standard Deviation 29.1	-3.9 score on a scale Standard Deviation 25.6
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Insomnia: Change at C6D1	-2.0 score on a scale Standard Deviation 30.3	-2.4 score on a scale Standard Deviation 28.2
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Insomnia: Change at C7D1	-4.1 score on a scale Standard Deviation 28.2	-1.8 score on a scale Standard Deviation 27.2
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Nausea/Vomiting: Baseline	5.9 score on a scale Standard Deviation 13.4	6.7 score on a scale Standard Deviation 13.7
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Nausea/Vomiting: Change at C2D1	0.1 score on a scale Standard Deviation 11.9	1.6 score on a scale Standard Deviation 18.1
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Nausea/Vomiting: Change at C3D1	0.7 score on a scale Standard Deviation 15.2	2.2 score on a scale Standard Deviation 17.6
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Pain: Change at C2D1	-0.2 score on a scale Standard Deviation 24.0	-5.0 score on a scale Standard Deviation 20.8
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Physical Functioning: Change at C5D1	2.0 score on a scale Standard Deviation 17.7	1.0 score on a scale Standard Deviation 13.5
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Global Health Status/ QoL: Change at C3D1	-1.0 score on a scale Standard Deviation 18.5	-1.5 score on a scale Standard Deviation 20.9
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Emotional Functioning: Change at C3D1	4.5 score on a scale Standard Deviation 19.1	2.3 score on a scale Standard Deviation 21.6
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Emotional Functioning: Change at C4D1	4.5 score on a scale Standard Deviation 18.5	2.6 score on a scale Standard Deviation 19.7
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Emotional Functioning: Change at C5D1	5.2 score on a scale Standard Deviation 20.1	-0.4 score on a scale Standard Deviation 21.8
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Emotional Functioning: Change at C6D1	2.1 score on a scale Standard Deviation 20.5	2.4 score on a scale Standard Deviation 21.6
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Emotional Functioning: Change at C7D1	5.3 score on a scale Standard Deviation 20.7	2.8 score on a scale Standard Deviation 19.7
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Fatigue: Baseline	30.8 score on a scale Standard Deviation 22.5	30.8 score on a scale Standard Deviation 22.0
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Fatigue: Change at C2D1	2.0 score on a scale Standard Deviation 19.2	-0.5 score on a scale Standard Deviation 18.8
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Fatigue: Change at C3D1	-1.5 score on a scale Standard Deviation 19.5	1.8 score on a scale Standard Deviation 21.5
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Fatigue: Change at C5D1	-0.1 score on a scale Standard Deviation 20.8	2.8 score on a scale Standard Deviation 20.4
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Fatigue: Change at C6D1	3.3 score on a scale Standard Deviation 20.0	2.4 score on a scale Standard Deviation 20.5
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Fatigue: Change at C7D1	1.0 score on a scale Standard Deviation 20.0	1.8 score on a scale Standard Deviation 20.5
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Financial Difficulties: Change at C2D1	-1.1 score on a scale Standard Deviation 20.4	-2.8 score on a scale Standard Deviation 21.4
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Financial Difficulties: Change at C5D1	-0.4 score on a scale Standard Deviation 28.0	0.3 score on a scale Standard Deviation 24.9
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Financial Difficulties: Change at C6D1	5.6 score on a scale Standard Deviation 30.1	0.4 score on a scale Standard Deviation 23.6
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Financial Difficulties: Change at C7D1	-0.6 score on a scale Standard Deviation 26.1	2.1 score on a scale Standard Deviation 23.1
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Global Health Status/ QoL: Baseline	65.2 score on a scale Standard Deviation 18.4	67.4 score on a scale Standard Deviation 20.3
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Global Health Status/ QoL: Change at C2D1	-0.1 score on a scale Standard Deviation 16.7	1.0 score on a scale Standard Deviation 19.9
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Global Health Status/ QoL: Change at C4D1	-1.5 score on a scale Standard Deviation 18.6	-1.6 score on a scale Standard Deviation 20.3
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Global Health Status/ QoL: Change at C5D1	0.3 score on a scale Standard Deviation 19.9	-2.8 score on a scale Standard Deviation 20.3
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Global Health Status/ QoL: Change at C6D1	-1.6 score on a scale Standard Deviation 18.6	-3.4 score on a scale Standard Deviation 19.5
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Global Health Status/ QoL: Change at C7D1	-1.1 score on a scale Standard Deviation 18.9	-1.0 score on a scale Standard Deviation 18.9
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Insomnia: Baseline	26.0 score on a scale Standard Deviation 27.6	26.5 score on a scale Standard Deviation 27.7
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Insomnia: Change at C2D1	-0.9 score on a scale Standard Deviation 24.4	-3.8 score on a scale Standard Deviation 23.7
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Insomnia: Change at C3D1	-3.4 score on a scale Standard Deviation 30.1	-4.1 score on a scale Standard Deviation 26.4
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Insomnia: Change at C4D1	-4.0 score on a scale Standard Deviation 28.9	-1.0 score on a scale Standard Deviation 26.8
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Nausea/Vomiting: Change at C4D1	0.3 score on a scale Standard Deviation 17.9	2.3 score on a scale Standard Deviation 18.6
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Nausea/Vomiting: Change at C5D1	-1.1 score on a scale Standard Deviation 18.3	0.5 score on a scale Standard Deviation 15.4
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Nausea/Vomiting: Change at C6D1	1.5 score on a scale Standard Deviation 18.0	-0.6 score on a scale Standard Deviation 15.9
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Appetite Loss: Baseline	15.9 score on a scale Standard Deviation 25.9	15.3 score on a scale Standard Deviation 23.3
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Appetite Loss: Change at C2D1	-0.2 score on a scale Standard Deviation 25.7	6.2 score on a scale Standard Deviation 26.2
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Appetite Loss: Change at C3D1	-4.3 score on a scale Standard Deviation 27.2	8.7 score on a scale Standard Deviation 28.1
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Appetite Loss: Change at C4D1	-1.7 score on a scale Standard Deviation 26.1	8.4 score on a scale Standard Deviation 28.1
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Appetite Loss: Change at C5D1	-0.4 score on a scale Standard Deviation 26.6	6.0 score on a scale Standard Deviation 27.2
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Appetite Loss: Change at C6D1	-0.5 score on a scale Standard Deviation 22.3	6.6 score on a scale Standard Deviation 27.2
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Appetite Loss: Change at C7D1	-5.7 score on a scale Standard Deviation 28.7	4.6 score on a scale Standard Deviation 26.5
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Cognitive Functioning: Baseline	85.3 score on a scale Standard Deviation 18.1	85.9 score on a scale Standard Deviation 18.7
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Cognitive Functioning: Change at C2D1	0.7 score on a scale Standard Deviation 16.5	-1.1 score on a scale Standard Deviation 16.8
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Cognitive Functioning: Change at C3D1	0.9 score on a scale Standard Deviation 17.9	-2.9 score on a scale Standard Deviation 19.1
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Cognitive Functioning: Change at C4D1	1.8 score on a scale Standard Deviation 18.9	-1.7 score on a scale Standard Deviation 18.4
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Cognitive Functioning: Change at C5D1	-1.5 score on a scale Standard Deviation 17.7	-3.2 score on a scale Standard Deviation 17.7
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Cognitive Functioning: Change at C6D1	-0.5 score on a scale Standard Deviation 18.5	-2.8 score on a scale Standard Deviation 17.6
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Cognitive Functioning: Change at C7D1	-2.3 score on a scale Standard Deviation 18.1	-0.8 score on a scale Standard Deviation 18.8
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Constipation: Baseline	15.8 score on a scale Standard Deviation 23.9	14.5 score on a scale Standard Deviation 23.7
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Constipation: Change at C2D1	0.0 score on a scale Standard Deviation 24.0	-6.0 score on a scale Standard Deviation 21.1
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Constipation: Change at C3D1	-2.3 score on a scale Standard Deviation 25.0	-4.9 score on a scale Standard Deviation 20.8
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Constipation: Change at C4D1	-2.7 score on a scale Standard Deviation 24.6	-5.5 score on a scale Standard Deviation 22.0
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Constipation: Change at C5D1	-1.3 score on a scale Standard Deviation 22.7	-4.0 score on a scale Standard Deviation 21.0
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Constipation: Change at C6D1	-3.0 score on a scale Standard Deviation 27.3	-3.5 score on a scale Standard Deviation 21.8
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Constipation: Change at C7D1	-4.6 score on a scale Standard Deviation 24.5	-6.9 score on a scale Standard Deviation 22.5
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Diarrhoea: Baseline	6.3 score on a scale Standard Deviation 15.1	5.0 score on a scale Standard Deviation 14.4
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Diarrhoea: Change at C2D1	-0.5 score on a scale Standard Deviation 17.9	10.2 score on a scale Standard Deviation 22.4
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Diarrhoea: Change at C3D1	-0.9 score on a scale Standard Deviation 16.6	13.7 score on a scale Standard Deviation 26.3
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Diarrhoea: Change at C4D1	-2.7 score on a scale Standard Deviation 21.0	13.1 score on a scale Standard Deviation 28.9
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Diarrhoea: Change at C5D1	-2.6 score on a scale Standard Deviation 19.4	11.1 score on a scale Standard Deviation 27.7
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Diarrhoea: Change at C6D1	-2.0 score on a scale Standard Deviation 17.4	14.0 score on a scale Standard Deviation 29.1
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Diarrhoea: Change at C7D1	1.1 score on a scale Standard Deviation 20.7	15.6 score on a scale Standard Deviation 30.9
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Dyspnoea: Baseline	15.0 score on a scale Standard Deviation 23.0	15.4 score on a scale Standard Deviation 22.2
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Dyspnoea: Change at C2D1	4.1 score on a scale Standard Deviation 23.5	-2.1 score on a scale Standard Deviation 19.5
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Dyspnoea: Change at C3D1	2.8 score on a scale Standard Deviation 20.3	0.0 score on a scale Standard Deviation 20.9
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Dyspnoea: Change at C4D1	0.7 score on a scale Standard Deviation 23.2	0.0 score on a scale Standard Deviation 23.3
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Dyspnoea: Change at C5D1	2.6 score on a scale Standard Deviation 26.5	1.6 score on a scale Standard Deviation 23.2
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Dyspnoea: Change at C6D1	3.0 score on a scale Standard Deviation 26.6	0.2 score on a scale Standard Deviation 23.4
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Dyspnoea: Change at C7D1	1.7 score on a scale Standard Deviation 24.5	-2.1 score on a scale Standard Deviation 21.2
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Emotional Functioning: Baseline	73.1 score on a scale Standard Deviation 22.1	71.9 score on a scale Standard Deviation 22.1
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Emotional Functioning: Change at C2D1	4.0 score on a scale Standard Deviation 17.9	5.1 score on a scale Standard Deviation 18.5
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Nausea/Vomiting: Change at C7D1	2.6 score on a scale Standard Deviation 15.5	2.2 score on a scale Standard Deviation 18.8
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Pain: Baseline	28.0 score on a scale Standard Deviation 25.4	27.1 score on a scale Standard Deviation 24.9
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Pain: Change at C3D1	-3.7 score on a scale Standard Deviation 23.3	-3.5 score on a scale Standard Deviation 22.6
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Pain: Change at C4D1	-3.2 score on a scale Standard Deviation 24.7	-1.7 score on a scale Standard Deviation 24.2
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Pain: Change at C5D1	-3.3 score on a scale Standard Deviation 24.2	-4.3 score on a scale Standard Deviation 22.9
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Pain: Change at C6D1	-1.0 score on a scale Standard Deviation 23.0	-2.2 score on a scale Standard Deviation 22.5
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Pain: Change at C7D1	0.3 score on a scale Standard Deviation 23.5	-4.4 score on a scale Standard Deviation 19.8
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Physical Functioning: Baseline	76.7 score on a scale Standard Deviation 19.9	78.4 score on a scale Standard Deviation 18.8
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Physical Functioning: Change at C2D1	-1.1 score on a scale Standard Deviation 13.4	1.6 score on a scale Standard Deviation 12.7
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Physical Functioning: Change at C3D1	2.0 score on a scale Standard Deviation 14.1	0.8 score on a scale Standard Deviation 15.7
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Physical Functioning: Change at C4D1	1.5 score on a scale Standard Deviation 16.1	0.3 score on a scale Standard Deviation 15.7
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Physical Functioning: Change at C6D1	0.9 score on a scale Standard Deviation 18.4	1.1 score on a scale Standard Deviation 14.9
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Physical Functioning: Change at C7D1	1.6 score on a scale Standard Deviation 16.2	0.6 score on a scale Standard Deviation 14.2
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Role Functioning: Baseline	79.1 score on a scale Standard Deviation 24.6	78.7 score on a scale Standard Deviation 24.0
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Role Functioning: Change at C2D1	-2.0 score on a scale Standard Deviation 19.3	1.7 score on a scale Standard Deviation 21.5
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Role Functioning: Change at C3D1	-0.4 score on a scale Standard Deviation 23.4	-1.0 score on a scale Standard Deviation 23.9
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Role Functioning: Change at C4D1	0.3 score on a scale Standard Deviation 23.0	0.4 score on a scale Standard Deviation 24.2
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Role Functioning: Change at C5D1	1.8 score on a scale Standard Deviation 22.5	-1.6 score on a scale Standard Deviation 21.6
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Role Functioning: Change at C6D1	-1.3 score on a scale Standard Deviation 23.8	-1.6 score on a scale Standard Deviation 23.4
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Role Functioning: Change at C7D1	-0.3 score on a scale Standard Deviation 22.6	0.0 score on a scale Standard Deviation 22.9
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Social Functioning: Baseline	83.2 score on a scale Standard Deviation 21.8	81.2 score on a scale Standard Deviation 23.1
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Social Functioning: Change at C2D1	-0.8 score on a scale Standard Deviation 19.9	2.7 score on a scale Standard Deviation 20.0
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Social Functioning: Change at C3D1	1.3 score on a scale Standard Deviation 21.9	-0.8 score on a scale Standard Deviation 23.2
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Social Functioning: Change at C4D1	1.8 score on a scale Standard Deviation 18.2	-0.5 score on a scale Standard Deviation 21.3
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Social Functioning: Change at C5D1	0.9 score on a scale Standard Deviation 19.4	-1.0 score on a scale Standard Deviation 23.3
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Social Functioning: Change at C6D1	-0.8 score on a scale Standard Deviation 20.1	-1.6 score on a scale Standard Deviation 23.4
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score Social Functioning: Change at C7D1	0.6 score on a scale Standard Deviation 21.2	0.1 score on a scale Standard Deviation 19.7

SECONDARY outcome

Timeframe: Baseline, C2D1 up to C7D1 (each cycle=28 days)

Population: Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment. Data are reported for evaluable participants.

EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores were averaged and transformed to a 0-100 scale. Higher scores for the functional scales indicated a higher/better level of functioning/healthy functioning. Higher scores for the symptom scales indicated worse symptoms.

Outcome measures

Outcome measures
Measure	Placebo+Fulvestrant n=176 Participants Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.	Taselisib+Fulvestrant n=340 Participants Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Body Image: Change at C3D1	1.6 score on a scale Standard Deviation 18.0	1.1 score on a scale Standard Deviation 20.6
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Body Image: Change at C4D1	1.1 score on a scale Standard Deviation 17.8	1.8 score on a scale Standard Deviation 20.6
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Body Image: Change at C6D1	1.1 score on a scale Standard Deviation 21.0	0.4 score on a scale Standard Deviation 18.2
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Breast Symptoms: Change at C6D1	1.7 score on a scale Standard Deviation 16.0	-2.0 score on a scale Standard Deviation 12.9
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Future Perspective: Change at C2D1	3.4 score on a scale Standard Deviation 30.1	6.8 score on a scale Standard Deviation 27.4
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Future Perspective: Change at C5D1	6.0 score on a scale Standard Deviation 30.3	5.0 score on a scale Standard Deviation 26.8
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Arm Symptoms: Baseline	15.5 score on a scale Standard Deviation 18.8	19.3 score on a scale Standard Deviation 21.1
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Arm Symptoms: Change at C2D1	0.1 score on a scale Standard Deviation 17.4	-5.4 score on a scale Standard Deviation 15.6
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Arm Symptoms: Change at C3D1	-0.7 score on a scale Standard Deviation 19.5	-6.1 score on a scale Standard Deviation 17.4
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Arm Symptoms: Change at C4D1	-1.4 score on a scale Standard Deviation 21.9	-5.8 score on a scale Standard Deviation 15.8
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Arm Symptoms: Change at C5D1	0.8 score on a scale Standard Deviation 17.0	-6.6 score on a scale Standard Deviation 15.7
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Arm Symptoms: Change at C6D1	1.1 score on a scale Standard Deviation 20.8	-5.0 score on a scale Standard Deviation 18.5
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Arm Symptoms: Change at C7D1	-1.2 score on a scale Standard Deviation 19.7	-6.0 score on a scale Standard Deviation 15.2
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Body Image: Baseline	82.0 score on a scale Standard Deviation 21.7	80.8 score on a scale Standard Deviation 22.5
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Body Image: Change at C2D1	1.8 score on a scale Standard Deviation 14.9	1.5 score on a scale Standard Deviation 16.5
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Body Image: Change at C5D1	0.2 score on a scale Standard Deviation 19.5	0.0 score on a scale Standard Deviation 17.5
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Body Image: Change at C7D1	5.6 score on a scale Standard Deviation 18.8	-0.3 score on a scale Standard Deviation 18.2
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Breast Symptoms: Baseline	8.7 score on a scale Standard Deviation 14.6	11.0 score on a scale Standard Deviation 14.1
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Breast Symptoms: Change at C2D1	0.0 score on a scale Standard Deviation 13.7	-3.0 score on a scale Standard Deviation 11.8
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Breast Symptoms: Change at C3D1	-0.8 score on a scale Standard Deviation 13.3	-3.5 score on a scale Standard Deviation 11.6
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Breast Symptoms: Change at C4D1	0.1 score on a scale Standard Deviation 14.2	-3.0 score on a scale Standard Deviation 11.8
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Breast Symptoms: Change at C5D1	-0.9 score on a scale Standard Deviation 14.5	-2.0 score on a scale Standard Deviation 11.7
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Breast Symptoms: Change at C7D1	0.3 score on a scale Standard Deviation 12.6	-3.2 score on a scale Standard Deviation 13.1
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Future Perspective: Baseline	47.4 score on a scale Standard Deviation 31.5	47.3 score on a scale Standard Deviation 29.6
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Future Perspective: Change at C3D1	5.1 score on a scale Standard Deviation 29.5	4.3 score on a scale Standard Deviation 30.5
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Future Perspective: Change at C4D1	6.0 score on a scale Standard Deviation 30.7	7.0 score on a scale Standard Deviation 29.2
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Future Perspective: Change at C6D1	6.9 score on a scale Standard Deviation 28.8	9.0 score on a scale Standard Deviation 31.4
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Future Perspective: Change at C7D1	12.9 score on a scale Standard Deviation 29.4	7.0 score on a scale Standard Deviation 30.2
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Sexual Enjoyment: Baseline	51.9 score on a scale Standard Deviation 26.7	62.8 score on a scale Standard Deviation 26.6
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Sexual Enjoyment: Change at C2D1	5.9 score on a scale Standard Deviation 21.2	0.0 score on a scale Standard Deviation 18.1
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Sexual Enjoyment: Change at C3D1	4.8 score on a scale Standard Deviation 22.1	1.3 score on a scale Standard Deviation 24.0
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Sexual Enjoyment: Change at C4D1	-8.3 score on a scale Standard Deviation 15.4	4.2 score on a scale Standard Deviation 24.7
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Sexual Enjoyment: Change at C5D1	-4.8 score on a scale Standard Deviation 23.0	2.6 score on a scale Standard Deviation 29.7
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Sexual Enjoyment: Change at C6D1	-6.7 score on a scale Standard Deviation 14.9	-5.9 score on a scale Standard Deviation 24.3
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Sexual Enjoyment: Change at C7D1	-13.3 score on a scale Standard Deviation 29.8	9.5 score on a scale Standard Deviation 20.4
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Sexual Functioning: Baseline	89.6 score on a scale Standard Deviation 17.9	89.9 score on a scale Standard Deviation 17.3
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Sexual Functioning: Change at C2D1	1.6 score on a scale Standard Deviation 11.0	1.5 score on a scale Standard Deviation 14.2
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Sexual Functioning: Change at C3D1	1.4 score on a scale Standard Deviation 10.6	1.8 score on a scale Standard Deviation 15.6
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Sexual Functioning: Change at C4D1	1.9 score on a scale Standard Deviation 15.4	1.6 score on a scale Standard Deviation 13.9
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Sexual Functioning: Change at C5D1	-0.8 score on a scale Standard Deviation 20.6	2.6 score on a scale Standard Deviation 15.1
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Sexual Functioning: Change at C6D1	2.4 score on a scale Standard Deviation 18.8	2.7 score on a scale Standard Deviation 15.0
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Sexual Functioning: Change at C7D1	2.7 score on a scale Standard Deviation 18.1	2.3 score on a scale Standard Deviation 15.7
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Systematic Therapy SEs: Baseline	15.7 score on a scale Standard Deviation 14.2	14.7 score on a scale Standard Deviation 12.0
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Systematic Therapy SEs: Change at C2D1	0.2 score on a scale Standard Deviation 11.4	2.5 score on a scale Standard Deviation 11.0
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Systematic Therapy SEs: Change at C3D1	1.2 score on a scale Standard Deviation 14.4	4.0 score on a scale Standard Deviation 13.6
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Systematic Therapy SEs: Change at C4D1	1.5 score on a scale Standard Deviation 13.2	4.0 score on a scale Standard Deviation 13.3
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Systematic Therapy SEs: Change at C5D1	2.4 score on a scale Standard Deviation 13.8	5.5 score on a scale Standard Deviation 14.1
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Systematic Therapy SEs: Change at C6D1	2.9 score on a scale Standard Deviation 15.2	5.7 score on a scale Standard Deviation 15.6
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Systematic Therapy SEs: Change at C7D1	3.5 score on a scale Standard Deviation 16.7	4.8 score on a scale Standard Deviation 15.0
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Upset by Hair Loss: Baseline	23.2 score on a scale Standard Deviation 28.2	27.0 score on a scale Standard Deviation 29.2
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Upset by Hair Loss: Change at C2D1	-11.9 score on a scale Standard Deviation 28.1	-4.3 score on a scale Standard Deviation 22.3
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Upset by Hair Loss: Change at C3D1	-7.7 score on a scale Standard Deviation 30.9	0.0 score on a scale Standard Deviation 26.7
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Upset by Hair Loss: Change at C4D1	2.6 score on a scale Standard Deviation 16.5	0.0 score on a scale Standard Deviation 29.2
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Upset by Hair Loss: Change at C5D1	0.0 score on a scale Standard Deviation 25.2	10.7 score on a scale Standard Deviation 27.3
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Upset by Hair Loss: Change at C6D1	11.1 score on a scale Standard Deviation 27.2	16.7 score on a scale Standard Deviation 30.2
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score Upset by Hair Loss: Change at C7D1	4.2 score on a scale Standard Deviation 11.8	14.1 score on a scale Standard Deviation 32.9

Adverse Events

Placebo+Fulvestrant

Serious events: 23 serious events

Other events: 183 other events

Deaths: 100 deaths

Taselisib+Fulvestrant

Serious events: 154 serious events

Other events: 396 other events

Deaths: 197 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER