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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

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. Identifier: NCT00036621
Recruitment Status : Terminated
First Posted : May 13, 2002
Last Update Posted : March 2, 2010
Information provided by:
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: BMS-275291 Phase 2

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Actual Primary Completion Date : September 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT00036621

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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

Layout table for additonal information Identifier: NCT00036621    
Other Study ID Numbers: CA161-006
First Posted: May 13, 2002    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: August 2007
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases