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Preoperative Cisplatin in Early Stage Breast Cancer

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ClinicalTrials.gov Identifier: NCT00148694
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : August 31, 2016
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Brigham and Women's Hospital
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Judy E. Garber, MD, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Cisplatin Phase 2

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  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Cisplatin in Early Stage ER-, PR-, HER-2 Negative Breast Cancer
Study Start Date : July 2004
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Cisplatin
U.S. FDA Resources

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



Primary Outcome Measures :
  1. To determine the clinical response after preoperative therapy with cisplatin in ER-, PR-, HER-2 negative early breast cancer patients

Secondary Outcome Measures :
  1. To determine the pathologic complete response after preoperative therapy with cisplatin in this patient population


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00148694


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Brigham and Women's Hospital
Breast Cancer Research Foundation
Investigators
Principal Investigator: Judy E. Garber, MD Dana-Farber Cancer Institute

Publications of Results:
Responsible Party: Judy E. Garber, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00148694     History of Changes
Other Study ID Numbers: 04-183
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Judy E. Garber, MD, Dana-Farber Cancer Institute:
Cisplatin
Early Stage Breast Cancer
ER Negative Breast Cancer
PR Negative Breast Cancer
HER-2 Negative Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cisplatin
Antineoplastic Agents