Cisplatin + RT for Triple Negative Breast Cancer
NCT01674842 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2021-08-25
Summary
This is a Phase I dose escalation study of cisplatin and concurrent radiation in patients with ER negative, PR negative and HER2 negative breast cancer who have undergone breast-conserving surgery or mastectomy.
Primary objective: To assess the safety, tolerability, and maximum tolerated dose (MTD) of cisplatin when given concurrently with radiation therapy for participants with Stage II or III breast cancer who have undergone breast conserving surgery or mastectomy
Conditions
Interventions
- RADIATION
-
Radiation Therapy
Once daily, Monday - Friday for six weeks
- DRUG
-
Intravenously, once weekly for six weeks
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Jennifer R Bellon, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-10-31
- Primary Completion
- 2018-08-31
- Completion
- 2021-06-08
Countries
- United States
Study Locations
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