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Clinical Trials in the Netherlands / 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 Netherlands 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 the Netherlands

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Checkpoint Inhibition and Chemoradiotherapy as Bladder Sparing Treatment in UC Active, not recruiting
DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy Recruiting
Feasibility of CBCT-Guided Online Adaptive Radiotherapy (FASCINATE) Recruiting

Other trials for the same condition

Breast Reconstruction and Radiotherapy Recruiting
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor. Active, not recruiting
Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients Recruiting
Supplemental Screening for Women With Extremely Dense Breast Tissue: the DENSE-2 Trial Recruiting
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) Active, not recruiting
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 the Netherlands