Preoperative Cisplatin in Early Stage Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to find out what effects the preoperative therapy cisplatin will have on patients with early stage estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), or HER-2 negative breast cancer.

Detailed Description
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Before starting treatment patients will undergo placement of a clip into the tumor bed so the surgeon can locate the site of the tumor at the time of surgery. Patients will receive cisplatin intravenously once every three weeks for a total of 4 cycles or 12 weeks of treatment. After completion of cisplatin, patients will undergo surgery to remove any tumor that remains and to assess the tissue to see if tumor cells remain in the breast. Patients may receive a second breast MRI and biopsy 7-14 days after treatment begins to see whether we can identify tumors that will ultimately respond to cisplatin with a rapid evaluation. Patients will receive study treatment for approximately 12 weeks unless unacceptable toxicity occurs. After surgery patients will receive standard adjuvant therapy based on discussion with their physician. Follow-up progress will occur for several years.

Official Title
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A Phase II Trial of Cisplatin in Early Stage ER-, PR-, HER-2 Negative Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All tumors must be ER-, PR- and HER-2 negative. Age > 18 years ECOG performance status of less than or equal to 1 Absolute neutrophil count (ANC) > 1,500/mm3 Hemoglobin > 9mm/dl Platelets > 100,000/mm3 Creatinine < 1.5mg/dl Glucose < 200mg/dl Bilirubin < 1.5 x upper limit of normal (ULN) SGOT < 3.0 x ULN Exclusion Criteria: Prior chemotherapy treatment Pregnant or breast-feeding women History of serious illness, medical or psychiatric condition requiring medical management Uncontrolled infection Renal dysfunction Active or severe cardiovascular or pulmonary disease Peripheral neuropathy of any etiology that exceeds grade 1 Prior history of malignancy Uncontrolled diabetes

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: Intervention single arm<br>Cisplatin 75mg/m2 q21 days x 4 pre-surgery | Drug: Cisplatin<br>* Intravenously once every three weeks for a total of 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the clinical response after preoperative therapy with cisplatin in ER-, PR-, HER-2 negative early breast cancer patients |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the pathologic complete response after preoperative therapy with cisplatin in this patient population |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cisplatin, Early Stage Breast Cancer, ER Negative Breast Cancer, PR Negative Breast Cancer, HER-2 Negative Breast Cancer