Cisplatin + RT for Triple Negative Breast Cancer

Study Overview
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Brief Summary
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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
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This is a phase I dose escalation study of cisplatin and radiation to determine the toxicity of this combined treatment and establish an MTD.

Official Title
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A Phase I Dose-Escalation Study of Cisplatin and Radiation Therapy for Patients With Triple Negative Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Radiation Therapy
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cisplatin + Radiation Therapy<br>Cisplatin concurrently with radiation therapy | Radiation: Radiation Therapy<br>* Once daily, Monday - Friday for six weeks<br>Drug: Cisplatin<br>* Intravenously, once weekly for six weeks<br>* Other names: CDDP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Cisplatin w/ Radiation | 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 | 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 | To assess long-term toxicity in participants receiving cisplatin concurrently with radiation | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Triple negative, Stage II, Stage III