Preoperative Cisplatin in Early Stage Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Cisplatin

• Registration Number: NCT00148694
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-08
• Primary Completion: 2006-05
• Study Completion: 2010-05
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention single arm	Cisplatin	Cisplatin 75mg/m2 q21 days x 4 pre-surgery

Primary Outcome Measures

Name	Time	Method
To determine the clinical response after preoperative therapy with cisplatin in ER-, PR-, HER-2 negative early breast cancer patients

Secondary Outcome Measures

Name	Time	Method
To determine the pathologic complete response after preoperative therapy with cisplatin in this patient population

Trial Locations

Locations (3)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States