PER-061-06已完成未知
PROGRAM FOR THE EVALUATION OF CLINICAL TESTS IN CANCER (PACCT-1): STUDY ASSIGNING INDIVIDUAL OPTIONS FOR TREATMENT. THE TAILORX ASSAY
EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),0 个研究点目标入组 274 人开始时间: 2007年1月9日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 274
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •1. Patients with operable histologically confirmed adenocarcinoma of the breast who have completed primary surgical treatment and meet the following criteria: a) ER and/or progesterone receptor (PR)-positive. b) Negative axillary nodes. c) Tumor size 1.1-5.0 cm. d) The tumor must be human epidermal growth factor receptor 2 (Her2)/neu negative by either fluorescent in-situ hybridization (FISH) or immunohistochemistry.
- •2. The patient and physician must be agreeable to initiate standard chemotherapy and hormonal therapy as adjuvant therapy.
- •3. A tissue specimen from the primary breast cancer has been located and is ready to be shipped to the appropriate laboratory after consent is obtained and within 3 days following pre-registration.
- •4. Leukocyte count >= 3500/mm3.
- •5. Platelets >= 100,000/mm3.
- •6. Serum creatinine =< 1.5 mg/dL.
- •7. Serum aspartate transaminase (AST) that is =< 3-fold the upper institutional limits of normal.
- •8. Patients must be disease-free of prior invasive malignancies for >= 5 years.
- •9. Prior treatment: A) Mandatory prior surgery criteria: Patient must pre-register within 84 days from the final surgical procedure required to adequately treat the primary tumor AND All tumors should be removed by either a mastectomy or local excision plus an acceptable axillary procedure; there must be adequate tumor-free margins of resection in order for the patients to be eligible; patients with lobular carcinoma in-situ involving the resection margins are eligible. B) Criteria-other prior treatments: No prior chemotherapy for this malignancy AND No prior radiation therapy for this malignancy AND Hormonal therapy
- •10. Patients must have an anticipated life expectancy of at least 10 years.
- •11. Women must not be pregnant or breast-feeding.
- •12. Patients must not have previously had the Oncotype DX Assay performed.
排除标准
- •1. Chronic obstructive pulmonary disease requiring treatment-
- •2. Chronic liver disease.
- •3. Previous history of a cerebrovascular accident.
- •4. History of congestive heart failure or other cardiac disease that would represent a contraindication to the use of an anthracycline.
- •5. Chronic psychiatric condition or other condition that would impair compliance with the treatment regimen.
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