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NCT02437318 · OUTCOME

All Collected Deaths

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
Participants
Interval / dispersion
Not reported
Time frame
Pre-treatment: Up to 35 days. On-treatment: Up to approx. 6.5 years. Post-treatment survival follow-up: Up to approx. 6.5 years

What was measured

Pre-treatment deaths were collected from randomization to the day before first dose of study medication. On-treatment deaths were collected from start of treatment to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected from day 31 after last dose of study treatment to end of study.

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

Groups in this outcome

Alpelisib + Fulvestrant

Subjects with advanced breast cancer with or without a PIK3CA mutation 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)

Placebo + Fulvestrant

Subjects with advanced breast cancer with or without a PIK3CA mutation 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
Alpelisib + Fulvestrant284
Placebo + Fulvestrant288

Reported measurements

Pre-treatment

Analysis denominator · Participants

GroupSource count
Alpelisib + Fulvestrant284
Placebo + Fulvestrant288
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alpelisib + Fulvestrant0Not reportedNot reportedNot reportedNot reported
Placebo + Fulvestrant0Not reportedNot reportedNot reportedNot reported
On-treatment

Analysis denominator · Participants

GroupSource count
Alpelisib + Fulvestrant284
Placebo + Fulvestrant287
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alpelisib + Fulvestrant9Not reportedNot reportedNot reportedNot reported
Placebo + Fulvestrant12Not reportedNot reportedNot reportedNot reported
Post-treatment survival follow-up

Analysis denominator · Participants

GroupSource count
Alpelisib + Fulvestrant275
Placebo + Fulvestrant275
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alpelisib + Fulvestrant151Not reportedNot reportedNot reportedNot reported
Placebo + Fulvestrant156Not reportedNot reportedNot reportedNot reported
All deaths

Analysis denominator · Participants

GroupSource count
Alpelisib + Fulvestrant284
Placebo + Fulvestrant288
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alpelisib + Fulvestrant160Not reportedNot reportedNot reportedNot reported
Placebo + Fulvestrant168Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        284
      2. group Id
        OG001
        value
        288
      units
      Participants
    title
    Pre-treatment
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        12
    denoms
    1. counts
      1. group Id
        OG000
        value
        284
      2. group Id
        OG001
        value
        287
      units
      Participants
    title
    On-treatment
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        151
      2. group Id
        OG001
        value
        156
    denoms
    1. counts
      1. group Id
        OG000
        value
        275
      2. group Id
        OG001
        value
        275
      units
      Participants
    title
    Post-treatment survival follow-up
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        160
      2. group Id
        OG001
        value
        168
    denoms
    1. counts
      1. group Id
        OG000
        value
        284
      2. group Id
        OG001
        value
        288
      units
      Participants
    title
    All deaths
denoms
  1. counts
    1. group Id
      OG000
      value
      284
    2. group Id
      OG001
      value
      288
    units
    Participants
description
Pre-treatment deaths were collected from randomization to the day before first dose of study medication. On-treatment deaths were collected from start of treatment to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected from day 31 after last dose of study treatment to end of study.
groups
  1. description
    Subjects with advanced breast cancer with or without a PIK3CA mutation 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
    Alpelisib + Fulvestrant
  2. description
    Subjects with advanced breast cancer with or without a PIK3CA mutation 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
    Placebo + Fulvestrant
param Type
NUMBER
population Description
All subjects who were randomized to study treatment.
reporting Status
POSTED
time Frame
Pre-treatment: Up to 35 days. On-treatment: Up to approx. 6.5 years. Post-treatment survival follow-up: Up to approx. 6.5 years
title
All Collected Deaths
type
POST_HOC
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice