A Study of Rucaparib Administered With Radiation in Patients With Triple Negative Breast Cancer With an Incomplete Response Following Chemotherapy
NCT03542175 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2025-12-08
Summary
The purpose of this study is to test the safety of a study drug called Rucaparib, administered in combination with the type of radiation therapy that is usually given to women with your form of breast cancer.
Conditions
Interventions
- DRUG
-
Rucaparib
one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
- RADIATION
-
Radiotherapy
50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
Sponsors & Collaborators
-
Clovis Oncology, Inc.
collaborator INDUSTRY -
National Cancer Institute (NCI)
collaborator NIH -
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Atif Khan, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-23
- Primary Completion
- 2024-07-25
- Completion
- 2025-09-10
- FDA Drug
- Yes
Countries
- United States
Study Locations
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