Active — Not RecruitingPhase 3

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

United States1,837 participantsStarted 2014-04-22

Plain-language summary

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

Who can participate

Age range18 Years – 130 Years

SexALL

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Inclusion criteria

✓. Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative (not eligible for anti-HER2 therapy)
✓. ER and/or PgR positive, HER2 negative

Exclusion criteria

✕. adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1 endometrial carcinoma
✕. other solid tumours and lymphomas (without bone marrow involvement) diagnosed ≥ 5 years prior to randomisation and treated with no evidence of disease recurrence and for whom no more than one line of chemotherapy was applied.

What they're measuring

Invasive Disease Free Survival (IDFS)

Timeframe: From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)

Trial details

NCT IDNCT02032823

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-03-27

Results submitted2021-09-24

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