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NCT02000622 · FLOW

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Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations. · Source last updated 2026-02-13

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

groups
  1. id
    FG000
    title
    Olaparib 300 mg bd
  2. id
    FG001
    title
    Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        7
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        159
      2. group Id
        FG001
        num Subjects
        73
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawn due to site closure
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        205
      2. group Id
        FG001
        num Subjects
        97
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        17
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        169
      2. group Id
        FG001
        num Subjects
        80
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Screening occurred in 2 parts. Part 1: patients with unknown BRCA status were tested by Myriad. Part 1 screening failures were mostly due to no BRCA1/2 mutation detected. Part 2: patients with a known germline BRCA mutation were screened. 302 patients were randomized.
recruitment Details
The first patient was enrolled on 27 March 2014 and the last patient on 30 October 2015. Patients were randomized at 125 centres across 19 countries in North America, South America, Europe and Asia.
Complete source fields
groups
  1. id
    FG000
    title
    Olaparib 300 mg bd
  2. id
    FG001
    title
    Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        7
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        159
      2. group Id
        FG001
        num Subjects
        73
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawn due to site closure
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        205
      2. group Id
        FG001
        num Subjects
        97
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        17
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        169
      2. group Id
        FG001
        num Subjects
        80
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Screening occurred in 2 parts. Part 1: patients with unknown BRCA status were tested by Myriad. Part 1 screening failures were mostly due to no BRCA1/2 mutation detected. Part 2: patients with a known germline BRCA mutation were screened. 302 patients were randomized.
recruitment Details
The first patient was enrolled on 27 March 2014 and the last patient on 30 October 2015. Patients were randomized at 125 centres across 19 countries in North America, South America, Europe and Asia.

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

Preserved source evidence · Not medical advice