Preoperative Cisplatin in Early Stage Breast Cancer

August 29, 2016 updated by: Judy E. Garber, MD, Dana-Farber Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention single arm
Cisplatin 75mg/m2 q21 days x 4 pre-surgery
Drug: Cisplatin
Intravenously once every three weeks for a total of 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
To determine the pathologic complete response after preoperative therapy with cisplatin in this patient population

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Breast Cancer Research Foundation

Investigators

  • Principal Investigator: Judy E. Garber, MD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

August 31, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-183

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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