NCT00036621终止2 期
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 个研究点 分布在 1 个国家开始时间: 2002年5月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 试验地点
- 9
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
研究点 (9)
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