Clinical trial NCT00036621 (phase 2, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: bms-275291
SMILES: CNC(=O)[C@@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](S)CCN1C(=O)N(C)C(C)(C)C1=O)C(C)(C)C
Eligibility 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.