Effect of Chemotherapy and Radiation Prior to Surgery for Triple Negative Breast Cancer

• Status: Terminated
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine whether Cisplatin when given with radiation therapy prior to surgery is effective in improving response to treatment in breast cancer patients. Tumor, blood and bone marrow samples will be collected in this study and will also help researchers determine if cisplatin is able to change tumor DNA so it cannot multiply itself and create more tumor cells, and cause the tumor cells to die.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• Patients must be >= 18 years of age

• Patients must be newly diagnosed with primary invasive ductal breast adenocarcinoma.

• Tumor classified as clinically stage T2, T3 or T4 with any N (NX, N1, N2, or N3).

• Tumor does not express the following biomarkers: estrogen receptor, progesterone receptor, Her2/neu

• Adequate organ function defined as:

• Serum Creatinine <= 1.5 x upper limit of institutional normal.

• ALT, AST, ALK Phos <= 1.5 x upper limit of institutional normal.

• Bilirubin <= 1.5 x upper limit of institutional normal.

• Normal left ventricular function (LVEF > 50%) by MUGA or ECHO.

Exclusion Criteria:

• No evidence of distant metastasis present by CT, Bone scan, or physical exam. If the bone scan or CT scans demonstrate indeterminate lesions, the nature of these lesions should be further clarified by additional testing such as PET or MRI.

• No prior malignancies with the exception of curatively treated basal or squamous carcinoma of the skin or history of previous malignancies, treated with at least greater than 5 years disease free survival.

• Women of child bearing potential may not be currently pregnant or breastfeeding at time of registration and must agree to use adequate contraception.

• Karnofsky Performance Status of <= 70.

• Patients with known history neural deficiencies (e.g. peripheral neuropathy).

• Patients with a known hearing impairment (hearing loss or severe tinnitus).

• Male patients