A Randomized, Placebo-Controlled Trial of BMS-275291 Given Daily for 12 Months to Women With Stage 1c-IIIA Breast Cancer Receiving Adjuvant Chemotherapy and/or Hormonal Therapy

February 27, 2010 updated by: Bristol-Myers Squibb
This clinical trial will assess whether BMS-275291 can be administered safely in combination with standard adjuvant therapy for early breast cancer and whether plasma concentrations at trough exceed a target minimum.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

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
    • Illinois
      • Chicago, Illinois, United States
        • Local Institution
    • Indiana
      • Indianapolis, Indiana, United States
        • Local Institution
    • Maryland
      • Baltimore, Maryland, United States
        • Local Institution
    • New York
      • Bronx, New York, United States
        • Local Institution
    • Ohio
      • Cincinnati, Ohio, United States
        • Local Institution
    • Oregon
      • Portland, Oregon, United States
        • Local Institution
    • Vermont
      • Burlington, Vermont, United States
        • Local Institution
    • Washington
      • Vancouver, Washington, United States
        • Local Institution
    • Wisconsin
      • Green Bay, Wisconsin, United States
        • Local Institution

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:

  1. Histologically confirmed pathologic stage 1c-IIIA adenocarcinoma of the breast which has been completely resected.

  2. Systemic therapy is planned according to one of the following three regimens:

    • Tamoxifen (20mg) given orally once per day
    • Adriamycin (60 mg/m2 IV on Day 1) plus cyclophosphamide (600mg/m2 IV on Day 1), repeated every 21 days for four courses (to begin within 8 weeks after definitive surgery)
    • Adriamycin (60mg/m2 IV on Day 1) plus cyclophosphamide (600mg/m2 IV on Day 1), repeated every 21 days for four courses, followed by Taxol (175mg/m2 IV on Day 85) repeated every 21 days for four courses (to begin within 8 weeks after definitive surgery).
  3. ECOG performance status 0 or 1.

  4. Adequate organ function as evidenced by:

    • ANC > 1500/mm3
    • Platelets > 100,000/mm3
    • Serum Creatine < 1.5 ULN
    • Total bilirubin < 1.5 x ULN
    • AST < 2 x ULN
  5. Patients to receive adriamycin must have LVEF > 50% or acceptable function per the institutional practice as assessed by MUGA.
  6. Signed informed consent.
  7. Women age =/> 18 years
  8. Patients must have recovered from reversible adverse events of prior surgery and any radiation therapy.
  9. Women of childbearing potential must have a serum or urine pregnancy test within 72 hours prior to the start of study medication.

Exclusion Criteria:

  1. Patients in whom breast cancer is present at the margin or surgical resection are not eligible in this study. Patients suspicious for residual disease following resection are not eligible.
  2. Prior chemotherapy or immunotherapy for breast cancer.
  3. Documented metastatic breast cancer.
  4. Other malignancy (except carcinoma in situ of the cervix or surgically treated non-melanoma skin cancer) within 5 years of study entry.
  5. Pregnant or breastfeeding females.
  6. Women of child bearing potential not employing adequate contraception.
  7. History of autoimmune diseases such as systemic lupus, rheumatoid arthritis, scleroderma.
  8. Any serious underlying medical conditions which would impair the ability ot the patient to receive the planned treatment or which may interfere with the completion of this trial.
  9. Planned chemotherapy, hormonal therapy or biological therapy other than those described above. Patients should not be enrolled in any other clinical trials. Use of other investigational agents is not permitted.
  10. Any condition that does not permit compliance with the protocol.

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

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

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

Primary Completion (ACTUAL)

September 1, 2002

Study Registration Dates

First Submitted

May 11, 2002

First Submitted That Met QC Criteria

May 11, 2002

First Posted (ESTIMATE)

May 13, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

March 2, 2010

Last Update Submitted That Met QC Criteria

February 27, 2010

Last Verified

August 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA161-006

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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