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

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.