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NCT02437318 · OUTCOME

Overall Response Rate (ORR) 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

ORR was defined as the percentage of patients with best overall response of complete response (CR) or partial response (PR) based on local investigator's 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.

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 + Fulvestrant26.6Not reported20.134.0Not reported
PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant13.4Not reported8.719.4Not reported
PIK3CA Non-mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant20.9Not reported13.929.4Not reported
PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant12.9Not reported7.420.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.1
        upper Limit
        34.0
        value
        26.6
      2. group Id
        OG001
        lower Limit
        8.7
        upper Limit
        19.4
        value
        13.4
      3. group Id
        OG002
        lower Limit
        13.9
        upper Limit
        29.4
        value
        20.9
      4. group Id
        OG003
        lower Limit
        7.4
        upper Limit
        20.4
        value
        12.9
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
ORR was defined as the percentage of patients with best overall response of complete response (CR) or partial response (PR) based on local investigator's 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.
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
Overall Response Rate (ORR) Per Investigator Assessment
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice