A Phase III Clinical Trial Comparing TC to TAC for Women with Node-Positive orHigh-Risk Node-Negative, HER2-Negative Breast Cancer - NSABP B-46I

ICORG0 个研究点目标入组 140 人开始时间: 2010年7月8日最近更新: 2018年5月28日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 140

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: Female

入选标准

•-The patient must have signed and dated an approved consent form
•-Patients must be female.
•-patient must be = 18 and = 70 years old.
•- ECOG performance status of 0 or 1 (see Appendix B).
•- tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
•- HER2-negative breast cancer based on current ASCO/CAP Guideline
•Recommendations
•the following staging criteria must be met according to AJCC criteria:
•By pathologic evaluation,
•?primary tumor must be pT1-3;
•, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b,pN1c), pN2a, pN3a, or pN3b
•If pN0, at least one of the following criteria must be met:
•- ER negative and PgR negative; or
•- Pathologic tumor size > 2.0 cm; or
•- T1c (pathologic tumor size > 1.0 cm but = 2.0 cm) and ER positive (PgR status
•may be positive or negative) and either grade 3 histology or Oncotype DX®
•Recurrence Score of = 25.
•-Patients must have undergone either a total mastectomy or breast-conserving surgery(lumpectomy)
•- For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist- For patients who undergo mastectomy, margins must be histologically free of invasive tumor and DCIS.
•-Patients must have completed one of the following procedures for evaluation of
•pathologic nodal status:
•Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel
•lymphadenectomy is pN0, pN1mi, or pN1b;
•Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph
•nodes if the sentinel node (SN) is positive; or
•Axillary lymphadenectomy without SN isolation procedure.
•-The interval between the last surgery for breast cancer (treatment or staging) and
•randomization must be at least 28 days but no more than 84 days.
•(-Patients must have ER analysis performed on the primary tumor prior to randomization.
•If ER analysis is negative, then PgR analysis must also be performed. (Either a core
•biopsy or surgical resection specimen can be used for ER/PgR testing.)
•-The most recent postoperative blood counts, performed within 6 weeks prior to
•randomization, must meet the following criteria:
•ANC must be = 1200/mm3;
•platelet count must be = 100,000/mm3; and
•hemoglobin must be = 10 g/dL.
•-The following criteria for evidence of adequate hepatic function must be met based on the results of the most recent postoperative tests performed within 6 weeks prior to randomization:
•total bilirubin must be = ULN for the lab unless the patient has a bilirubin elevation
•> ULN to 1.5 x ULN due to Gilbert’s disease or similar syndrome involving slow
•conjugation of bilirubin; and
•alkaline phosphatase must be = 2.5 x ULN for the lab; and
•AST must be = 1.5 x ULN for the lab.
•Alkaline phosphatase and AST may not both be > the ULN. For example, if the
•alkaline phosphatase is > the ULN but = 2.5 x ULN, then the AST must be = the
•ULN. If the AST is > the ULN but = 1.5 x ULN, then the alkaline phosphatase must
•Note: If ALT is performed instead of AST (per institution's standard practice), the ALT
•value must be = 1.5 x ULN; if both were performed, the AST must be = 1.5 x ULN.
•NSABP B-46-I/USOR 07132 – Page 14
•-Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET-CT, or PET scan performed within 90 days prior to
•randomization) does not demonstrate metastatic disea

排除标准

•T4 tumors including inflammatory breast cancer.
•Definitive clinical or radiologic evidence of metastatic disease. (Chest imaging
•[mandatory for all patients] and other imaging within 90 days prior to randomization.)
•Synchronous or metachronous contralateral invasive breast cancer. (Patients with
•synchronous and/or metachronous contralateral DCIS are eligible.)
•Any history of ipsilateral invasive breast cancer or ipsilateral DCIS.
•History of non-breast malignancies within 5 years prior to randomization, except for the
•following: carcinoma in situ of the cervix, colorectal carcinoma in situ, melanoma in situ,
•and basal cell and squamous cell carcinomas of the skin.
•Previous therapy with anthracyclines, taxanes, or bevacizumab for any malignancy.
•Chemotherapy administered for the currently diagnosed breast cancer prior to
•randomization.
•Continued therapy with any hormonal agent such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. (Patients are eligible if these medications are
•discontinued prior to randomization.) Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy
•Patients are eligible if these medications are discontinued prior to
•randomization.
•Known active hepatitis B or hepatitis C with abnormal liver function tests.
•Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens.
•-Uncontrolled hypertension defined as systolic BP > 150 mmHg or diastolic BP
•> 90 mmHg, with or without anti-hypertensive medication. Patients with initial BP
•elevations are eligible if initiation or adjustment of BP medication lowers pressure to
•meet eligibility requirements.
•History of hypertensive crisis or hypertensive encephalopathy.
•History of TIA or CVA.
•History of any arterial thrombotic event within 12 months prior to randomization.
•Symptomatic peripheral vascular disease.
•Intrinsic lung disease resulting in dyspnea.
•Unstable diabetes mellitus.
•Active infection or chronic infection requiring suppressive antibiotics.
•History of a major organ allograft or condition requiring chronic immunosuppression,
•e.g., kidney, liver, lung, heart, bone marrow transplant, or autoimmune diseases.
•(Patients who have received corneal transplants, cadaver skin, or bone transplants are
•Any significant bleeding within 180 days prior to randomization, exclusive of
•menorrhagia in premenopausal women.
•Non-healing wound, skin ulcers, or incompletely healed bone fracture.
•Major surgical procedure, open biopsy, or significant traumatic injury within
•28 days prior to the planned start of study therapy. (Note: Placement of a vascular access
•device is not considered a major surgical procedure. See Section 7.3 for instructions
•regarding initiation of therapy after placement for Group 3 patients.)
•NSABP B-46-I/USOR 07132 – Page 16
•Anticipation of need for major surgical procedures during study therapy and for at least
•90 days following completion of bevacizumab. (See Section 7.9 regarding the timing of
•surgery to replace the tissue expanders with permanent implants for patients who have
•had breast reconstruction and other elective surgery.)
•Gastroduodenal ulcer(s) documented by endoscopy to be active within 180 days before
•randomization.
•History of GI perforation, abdominal fistulae, or intra-abdominal abscess.
•Known bleeding diathesis or coagulopathy.
•Requirement for therapeutic doses of

研究者

发起方

ICORG

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