drugset / Trial / NCT03286842
To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients.
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This open-label, multi-centre phase IIIb study will assess the effectiveness, benefits and potential harms in the use of olaparib monotherapy treatment for patients with HER2-ve metastatic breast cancer associated with germline or somatic breast cancer susceptibility gene (gBRCA1/2 or sBRCA1/2) mutations.
Timeline
- Start
- 2018-01-17
- Primary completion
- 2021-10-08
- Completion
- 2021-10-08
Publications
- Balmana J, Fasching PA, Couch FJ, Delaloge S, Labidi-Galy I, O'Shaughnessy J, Park YH, Eisen AF, You B, Bourgeois H, Goncalves A, Kemp Z, Swampillai A, Jankowski T, Sohn JH, Poddubskaya E, Mukhametshina G, Aksoy S, Timcheva CV, Park-Simon TW, Anton-Torres A, John E, Baria K, Gibson I, Gelmon KA; LUCY investigators. Clinical effectiveness and safety of olaparib in BRCA-mutated, HER2-negative metastatic breast cancer in a real-world setting: final analysis of LUCY. Breast Cancer Res Treat. 2024 Apr;204(2):237-248. doi: 10.1007/s10549-023-07165-x. Epub 2023 Dec 19.
- Gelmon KA, Fasching PA, Couch FJ, Balmana J, Delaloge S, Labidi-Galy I, Bennett J, McCutcheon S, Walker G, O'Shaughnessy J; Collaborating Investigators. Clinical effectiveness of olaparib monotherapy in germline BRCA-mutated, HER2-negative metastatic breast cancer in a real-world setting: phase IIIb LUCY interim analysis. Eur J Cancer. 2021 Jul;152:68-77. doi: 10.1016/j.ejca.2021.03.029. Epub 2021 Jun 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olaparib | Small molecule | 300 mg | Oral |