Clinical Trial: NCT02810743
Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | The Netherlands Cancer Institute |
| Information Provided By: | The Netherlands Cancer Institute |
| Last Update Posted: | 2026-06-01 |
Study Overview
Brief 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.
Official Title
Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer Patients With Personalized Therapy (SUBITO) - an International Randomized Phase III Trial
Conditions
Breast Cancer
Intervention / Treatment
- Drug: ddAC-CP-Olaparib
- Drug: ddAC-mini CTC
Other Study ID Numbers
- M16BRC
Start Date (Actual)
2017-01-25
Primary Completion Date (Actual)
2024-07-18
Study Completion Date (Estimated)
2033-12-01
Enrollment (Estimated)
174
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | The Netherlands Cancer Institute |
| Information Provided By: | The Netherlands Cancer Institute |
| Last Update Posted: | 2026-06-01 |
Study Overview
Brief 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.
Official Title
Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer Patients With Personalized Therapy (SUBITO) - an International Randomized Phase III Trial
Conditions
Breast Cancer
Intervention / Treatment
- Drug: ddAC-CP-Olaparib
- Drug: ddAC-mini CTC
Other Study ID Numbers
- M16BRC
Start Date (Actual)
2017-01-25
Primary Completion Date (Actual)
2024-07-18
Study Completion Date (Estimated)
2033-12-01
Enrollment (Estimated)
174
Study Type
Interventional
Phase
Phase 3