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Preoperative Cisplatin in Early Stage Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00148694
First Posted: September 8, 2005
Last Update Posted: August 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
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 Intervention Phase
Breast Cancer Drug: Cisplatin Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Judy E. Garber, MD, Dana-Farber Cancer Institute:

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

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

Enrollment: 27
Study Start Date: July 2004
Study Completion Date: May 2010
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Publications:
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 Submitted: September 7, 2005
First Posted: September 8, 2005
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