BENITIONSClinical Trial Intelligence

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

Phase 3 Active, not recruiting NCT02032823

ConditionBreast Cancer
PhasePhase 3
SponsorAstraZeneca
StatusActive, not recruiting
Enrollment1,837 participants
InterventionsOlaparib
Start dateApr 22, 2014
Completion dateMar 27, 2020
Results postedDec 8, 2021

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

Invasive Disease Free Survival (IDFS)

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

Olaparib106 Participants
Placebo178 Participants
p-value0.0000073
Hazard Ratio (HR)0.581 (95% CI 0.409–0.816)

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