Preoperative Cisplatin in Early Stage Breast Cancer

Dana-Farber Cancer Institute

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00148694

04-183

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Intervention single arm

Experimental group

Description:

Cisplatin 75mg/m2 q21 days x 4 pre-surgery

Treatment:

Drug: Cisplatin