Description:
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
Title
- Brief Title: Cisplatin + RT for Triple Negative Breast Cancer
- Official Title: A Phase I Dose-Escalation Study of Cisplatin and Radiation Therapy for Patients With Triple Negative Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
12-283
- NCT ID:
NCT01674842
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Cisplatin | CDDP | Cisplatin + Radiation Therapy |
Purpose
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
Detailed Description
This is a phase I dose escalation study of cisplatin and radiation to determine the toxicity
of this combined treatment and establish an MTD.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Cisplatin + Radiation Therapy | Experimental | Cisplatin concurrently with radiation therapy | |
Eligibility Criteria
Inclusion Criteria:
- Primary tumor is triple negative breast cancer
- Breast-conserving surgery or mastectomy with surgical excision of all gross disease
with negative surgical margins
- Pathologic or clinical stage II or III disease
- At least 3 week interval from last chemotherapy administration/breast surgery to
radiation (no more than 8 weeks)
Exclusion Criteria:
- Pregnant or breastfeeding
- Prior radiation to breast or ipsilateral regional nodes
- Ongoing therapy with other investigational agents
- Hormonal therapy
- Significant co-morbidity
- Pathologic complete response following preoperative chemotherapy
- Biopsy proven metastatic disease
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Safety of Cisplatin w/ Radiation |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | To determine the maximum tolerated dose 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. |
Secondary Outcome Measures
| Measure: | Local recurrence at 5 years |
| Time Frame: | 5 years |
| Safety Issue: | |
| Description: | To assess local recurrence at 5-years in participants receiving cisplatin concurrently with radiation, as compared with historic controls receiving radiation without concurrent chemotherapy. |
| Measure: | Long term toxicity |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | To assess long-term toxicity in participants receiving cisplatin concurrently with radiation |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Dana-Farber Cancer Institute |
Trial Keywords
- Triple negative
- Stage II
- Stage III
Last Updated
August 25, 2021
