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Clinical Trials in France / NCT02810743
Active, not recruiting Phase 3

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

NCT02810743 · tracked via the Priya Life Science France tracker
Sponsor
The Netherlands Cancer Institute
Phase
Phase 3
Started
2017-01-25
Last updated
2026-06-01

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

ddAC-CP-OlaparibddAC-mini CTC

ddAC-CP-Olaparib: ddAC-CP-Olaparib

ddAC-mini CTC: ddAC - mini CTC

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Overall survival in all patients — assessed up to 120 months
    time from randomization to death from any cause in all patients

Trial sites (11)

FacilityCityRegionStatus
Institut Paoli Calmettes Marseille France
Hopital Tenon, University Marie-Curie Paris France
Medical spectrum Twente Enschede Overijssel
Antoni van Leeuwenhoek Amsterdam Netherlands
AZVU Amsterdam Netherlands
University Medical Center Groningen Groningen Netherlands
LUMC Leiden Netherlands
Maastricht University Medical Center Maastricht Netherlands
Radboud UMC Nijmegen Netherlands
Erasmus Medical Center Cancer Institute Rotterdam Netherlands
University Medical Center Utrecht Utrecht Netherlands

More The Netherlands Cancer Institute trials in France

Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Active, not recruiting

Other trials for the same condition

DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer Active, not recruiting
Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Breast Cancer Active, not recruiting
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Recruiting
Development of Clinical and Biological Database Recruiting
I/II Phase Study Evaluating M1774 in Combination With Fulvestrant in HR+ and HER2- Advanced Breast Cancers Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02810743 on ClinicalTrials.gov ↗ ← All trials in France