drugset / Trial / NCT02810743

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

NCT02810743

Phase 3 Active not recruiting 174 enrolled The Netherlands Cancer Institute
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-01-25
Primary completion
2024-07-18
Completion
2033-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule 5 unknown Intravenous
Comparator Carboplatin Small molecule 6 unknown Intravenous
Comparator Carboplatin Small molecule 400 mg/m2 Intravenous
Comparator Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Comparator Cyclophosphamide Other / unclassified 3000 mg/m2 Intravenous
Comparator Olaparib Small molecule 300 mg Oral
Comparator Paclitaxel Small molecule 80 mg/m2 Intravenous
Comparator Thiotepa Other / unclassified 250 mg/m2
Comparator 2-MERCAPTOETHANESULFONIC ACID Small molecule 500 mg
Comparator 2-MERCAPTOETHANESULFONIC ACID Small molecule 2000 mg
Comparator Capecitabine Small molecule 1000 mg/m2
Comparator Capecitabine Small molecule 1250 mg/m2
Comparator Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Comparator Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous

Indications