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NCT02437318 · OUTCOME

Clinical Benefit Rate (CBR) Per Investigator Assessment

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment. · Source last updated 2025-02-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 56.4 months

What was measured

Clinical benefit rate was defined as the percentage of patients with a best overall response of CR or PR or stable disease (SD) or Non-CR/Non-PD lasting more than 24 weeks based on local investigator assessment according to RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.

Analysis population: All subjects who were randomized to study treatment.

Groups in this outcome

PIK3CA Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant

Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)

PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant

Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)

PIK3CA Non-mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant

Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)

PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant

Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
PIK3CA Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant169
PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant172
PIK3CA Non-mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant115
PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant116

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
PIK3CA Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant61.5Not reported53.868.9Not reported
PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant44.8Not reported37.252.5Not reported
PIK3CA Non-mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant53.9Not reported44.463.2Not reported
PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant49.1Not reported39.758.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        53.8
        upper Limit
        68.9
        value
        61.5
      2. group Id
        OG001
        lower Limit
        37.2
        upper Limit
        52.5
        value
        44.8
      3. group Id
        OG002
        lower Limit
        44.4
        upper Limit
        63.2
        value
        53.9
      4. group Id
        OG003
        lower Limit
        39.7
        upper Limit
        58.6
        value
        49.1
denoms
  1. counts
    1. group Id
      OG000
      value
      169
    2. group Id
      OG001
      value
      172
    3. group Id
      OG002
      value
      115
    4. group Id
      OG003
      value
      116
    units
    Participants
description
Clinical benefit rate was defined as the percentage of patients with a best overall response of CR or PR or stable disease (SD) or Non-CR/Non-PD lasting more than 24 weeks based on local investigator assessment according to RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
dispersion Type
95% Confidence Interval
groups
  1. description
    Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
    id
    OG000
    title
    PIK3CA Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant
  2. description
    Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
    id
    OG001
    title
    PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant
  3. description
    Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
    id
    OG002
    title
    PIK3CA Non-mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant
  4. description
    Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
    id
    OG003
    title
    PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant
param Type
NUMBER
population Description
All subjects who were randomized to study treatment.
reporting Status
POSTED
time Frame
Up to 56.4 months
title
Clinical Benefit Rate (CBR) Per Investigator Assessment
type
SECONDARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice