Participant flow

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer · Source last updated 2026-07-14

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

groups

1. description

   Olaparib tablets 300mg taken orally twice daily.

   id

   FG000

   title

   Olaparib

2. description

   Placebo tablets taken orally twice daily.

   id

   FG001

   title

   Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         107

      2. group Id

         FG001

         num Subjects

         143

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         36

      2. group Id

         FG001

         num Subjects

         36

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         78

      2. group Id

         FG001

         num Subjects

         64

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         697

      2. group Id

         FG001

         num Subjects

         666

      type

      Ongoing study at the data cut-off (DCO3: 05Jun2024)

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         6

      type

      Other (e.g investigators decision, protocol deviation, randomised by mistake)

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         921

      2. group Id

         FG001

         num Subjects

         915

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         921

      2. group Id

         FG001

         num Subjects

         915

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Patients with unknown germline BRCA (gBRCA) mutation status prior to randomisation underwent Screening Part 1 to ascertain gBRCA mutation status during, or prior to, neoadjuvant/adjuvant chemotherapy. All patients with known gBRCA mutation status (including those found through Screening Part 1) underwent Screening Part 2.

recruitment Details

The first patient was enrolled on 22 April 2014. Patients were randomised from 554 centres in 23 countries worldwide.

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

Preserved source evidence · Not medical advice