drugset / Trial / NCT02561832
A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety and Efficacy of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label study to assess the safety, tolerability and efficacy of olaparib in combination with carboplatin. There are two parts in this study: Part A, a dose escalation in patients with advanced Human Epidermal Growth Factor 2 (HER-2) negative breast cancer and Part B, a dose expansion in the neoadjuvant treatment of HER-2 negative breast cancer patients with germline Breast Cancer Susceptibility Gene (BRCA)1/2 mutations.
Timeline
- Start
- 2015-11-06
- Primary completion
- 2016-09-30
- Completion
- 2017-02-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Subject | Olaparib | Small molecule | 50 mg | Oral |
| Subject | Olaparib | Small molecule | 300 mg | Oral |
| Background | Cyclophosphamide | Other / unclassified | — | — |