Preoperative Cisplatin in Early Stage Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2010-05-31

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.

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention single arm

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

Group Type EXPERIMENTAL

Cisplatin

Intervention Type DRUG

Intravenously once every three weeks for a total of 12 weeks

Interventions

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Cisplatin

Intravenously once every three weeks for a total of 12 weeks

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No