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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

This study has been terminated.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00036621
First received: May 11, 2002
Last updated: February 27, 2010
Last verified: August 2007
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: BMS-275291
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036621

Locations
United States, Illinois
Local Institution
Chicago, Illinois, United States
United States, Indiana
Local Institution
Indianapolis, Indiana, United States
United States, Maryland
Local Institution
Baltimore, Maryland, United States
United States, New York
Local Institution
Bronx, New York, United States
United States, Ohio
Local Institution
Cincinnati, Ohio, United States
United States, Oregon
Local Institution
Portland, Oregon, United States
United States, Vermont
Local Institution
Burlington, Vermont, United States
United States, Washington
Local Institution
Vancouver, Washington, United States
United States, Wisconsin
Local Institution
Green Bay, Wisconsin, United States
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00036621     History of Changes
Other Study ID Numbers: CA161-006
Study First Received: May 11, 2002
Last Updated: February 27, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014