Preoperative Cisplatin in Early Stage Breast Cancer

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00148694
First received: September 7, 2005
Last updated: August 7, 2012
Last verified: August 2012
  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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 [ Time Frame: TBD ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the pathologic complete response after preoperative therapy with cisplatin in this patient population [ Time Frame: TBD ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148694

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
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
Study First Received: September 7, 2005
Last Updated: August 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 22, 2014