Active — Not RecruitingPhase 3

Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer

France, Netherlands174 participantsStarted 2017-01-25

Plain-language summary

Investigator-initiated, international, multicentre, randomized, open-label, (neo)adjuvant phase III study in target population (stage III, HER2-negative, BRCA1-like breast cancer patients) comparing optimized standard-dose chemotherapy with intensified, alkylating chemotherapy with stem cell rescue.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women and men with stage III adenocarcinoma of the breast harboring signs of a breast cancer with features of homologous recombination deficiency (HRD) * Age of 18-65 years * The tumor must be HER2-negative * Treatment must start within 8 weeks after the last surgical resection * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Exclusion Criteria: * Previous radiation therapy * Previous chemotherapy * Any previous treatment with a PARP-inhibitor, including olaparib * Pre-existing neuropathy from any cause in excess of Grade 1 * Chronic concomitant use of known strong or moderate CYP3A inducers

What they're measuring

Overall survival in all patients

Timeframe: assessed up to 120 months

Trial details

NCT IDNCT02810743

SponsorThe Netherlands Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-18

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