NCT00036621TerminatedPhase 2
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
Bristol-Myers Squibb9 sites in 1 countryStarted: May 13, 2002Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Locations
- 9
Study Overview
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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.
Exclusion Criteria
- •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.
Investigators
Study Sites (9)
Loading locations...
Similar Trials
Terminated
Phase 1
Combination Study of BMS-754807 and Erbitux® in Subjects With Advanced or Metastatic Solid TumorsHead and Neck CancerNeoplasm MetastasisColorectal CancerNCT00908024Bristol-Myers Squibb54
Terminated
Phase 2
Study of BMS-587101 in Patients With Moderate to Severe PsoriasisPsoriasis, Moderate to SevereNCT00162253Bristol-Myers Squibb120
Completed
Phase 2
A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung CancerNon-Small Cell Lung CancerNCT05005273Bristol-Myers Squibb1
Completed
Phase 2
A Study of BMS-582949 in Patients With Moderate to Severe Plaque PsoriasisPsoriasisNCT00399906Bristol-Myers Squibb99
Completed
Phase 1
Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast CancerBreast CancerNCT00788333Bristol-Myers Squibb40