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

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00036621

Run by

Bristol-Myers Squibb

Last updated by the study team

2010-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed pathologic stage 1c-IIIA adenocarcinoma of the breast which has been completely resected.
• 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).
• ECOG performance status 0 or 1.
• 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
• Patients to receive adriamycin must have LVEF > 50% or acceptable function per the institutional practice as assessed by MUGA.
• Signed informed consent.
• Women age =/> 18 years
• Patients must have recovered from reversible adverse events of prior surgery and any radiation therapy.
• Women of childbearing potential must have a serum or urine pregnancy test within 72 hours prior to the start of study medication.

You may not qualify if…

• 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.
• Prior chemotherapy or immunotherapy for breast cancer.
• Documented metastatic breast cancer.
• Other malignancy (except carcinoma in situ of the cervix or surgically treated non-melanoma skin cancer) within 5 years of study entry.
• Pregnant or breastfeeding females.
• Women of child bearing potential not employing adequate contraception.
• History of autoimmune diseases such as systemic lupus, rheumatoid arthritis, scleroderma.
• 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.
• 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.
• Any condition that does not permit compliance with the protocol.

Where it is running

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

Full record on ClinicalTrials.gov

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