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NCT02032823 · OUTCOME

Number of Participants With Contralateral Invasive and Non-invasive Breast Cancer, New Primary Ovarian Cancer, New Primary Fallopian Tube Cancer and New Primary Peritoneal Cancer

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)

What was measured

Number of patients with contralateral invasive breast cancer, contralateral non-invasive breast cancer, new primary ovarian cancer, new primary fallopian tube cancer and new primary peritoneal cancer. Analysis of contralateral breast cancers exclude patients with a bilateral mastectomy prior to randomisation. Analysis of new primary ovarian cancers excludes male patients and patients with a bilateral oophorectomy prior to randomisation. Analysis of new primary fallopian tube cancer excludes male patients and patients with a bilateral salpingectomy prior to randomisation. Analysis of new primary peritoneal cancers excludes male patients.

Analysis population: Full Analysis Set (FAS)

Groups in this outcome

Olaparib

Olaparib tablets 300mg taken orally twice daily.

Placebo

Placebo tablets taken orally twice daily.

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

Analysis denominator · Participants

GroupSource count
Olaparib921
Placebo915

Reported measurements

Contralateral invasive breast cancer

Analysis denominator · Participants

GroupSource count
Olaparib582
Placebo594
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib31Not reportedNot reportedNot reportedNot reported
Placebo40Not reportedNot reportedNot reportedNot reported
Contralateral non-invasive breast cancer

Analysis denominator · Participants

GroupSource count
Olaparib582
Placebo594
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib3Not reportedNot reportedNot reportedNot reported
Placebo4Not reportedNot reportedNot reportedNot reported
New primary ovarian cancer

Analysis denominator · Participants

GroupSource count
Olaparib734
Placebo745
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib3Not reportedNot reportedNot reportedNot reported
Placebo9Not reportedNot reportedNot reportedNot reported
New primary fallopian tube cancer

Analysis denominator · Participants

GroupSource count
Olaparib755
Placebo756
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib1Not reportedNot reportedNot reportedNot reported
Placebo4Not reportedNot reportedNot reportedNot reported
New primary peritoneal cancer

Analysis denominator · Participants

GroupSource count
Olaparib919
Placebo911
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib0Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        31
      2. group Id
        OG001
        value
        40
    denoms
    1. counts
      1. group Id
        OG000
        value
        582
      2. group Id
        OG001
        value
        594
      units
      Participants
    title
    Contralateral invasive breast cancer
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        582
      2. group Id
        OG001
        value
        594
      units
      Participants
    title
    Contralateral non-invasive breast cancer
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        9
    denoms
    1. counts
      1. group Id
        OG000
        value
        734
      2. group Id
        OG001
        value
        745
      units
      Participants
    title
    New primary ovarian cancer
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        755
      2. group Id
        OG001
        value
        756
      units
      Participants
    title
    New primary fallopian tube cancer
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        919
      2. group Id
        OG001
        value
        911
      units
      Participants
    title
    New primary peritoneal cancer
denoms
  1. counts
    1. group Id
      OG000
      value
      921
    2. group Id
      OG001
      value
      915
    units
    Participants
description
Number of patients with contralateral invasive breast cancer, contralateral non-invasive breast cancer, new primary ovarian cancer, new primary fallopian tube cancer and new primary peritoneal cancer. Analysis of contralateral breast cancers exclude patients with a bilateral mastectomy prior to randomisation. Analysis of new primary ovarian cancers excludes male patients and patients with a bilateral oophorectomy prior to randomisation. Analysis of new primary fallopian tube cancer excludes male patients and patients with a bilateral salpingectomy prior to randomisation. Analysis of new primary peritoneal cancers excludes male patients.
groups
  1. description
    Olaparib tablets 300mg taken orally twice daily.
    id
    OG000
    title
    Olaparib
  2. description
    Placebo tablets taken orally twice daily.
    id
    OG001
    title
    Placebo
param Type
COUNT_OF_PARTICIPANTS
population Description
Full Analysis Set (FAS)
reporting Status
POSTED
time Frame
From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
title
Number of Participants With Contralateral Invasive and Non-invasive Breast Cancer, New Primary Ovarian Cancer, New Primary Fallopian Tube Cancer and New Primary Peritoneal Cancer
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice