- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01674842
Cisplatin + RT for Triple Negative Breast Cancer
A Phase I Dose-Escalation Study of Cisplatin and Radiation Therapy for Patients With Triple Negative Breast Cancer
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
Milford, Massachusetts, United States, 01757
- Dana-Farber at Milford
-
Weymouth, Massachusetts, United States, 02190
- Dana Farber at South Shore Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cisplatin + Radiation Therapy
Cisplatin concurrently with radiation therapy
|
Once daily, Monday - Friday for six weeks
Intravenously, once weekly for six weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of Cisplatin w/ Radiation
Time Frame: 2 years
|
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.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local recurrence at 5 years
Time Frame: 5 years
|
To assess local recurrence at 5-years in participants receiving cisplatin concurrently with radiation, as compared with historic controls receiving radiation without concurrent chemotherapy.
|
5 years
|
Long term toxicity
Time Frame: 2 years
|
To assess long-term toxicity in participants receiving cisplatin concurrently with radiation
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer R Bellon, MD, Dana-Farber Cancer Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-283
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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