NCT00288002已完成3 期
A Randomized Phase III Study Exploring the Efficacy of Capecitabine Given Concomitantly or in Sequence to EC-Doc With or Without Trastuzumab as Neoadjuvant Treatment of Primary Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Pathologic complete response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, docetaxel, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy together with monoclonal antibodies before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving monoclonal antibodies after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective with or without capecitabine and/or trastuzumab in treating breast cancer.
PURPOSE: This randomized phase III trial is studying epirubicin, cyclophosphamide, and docetaxel to compare how well they work with or without capecitabine and/or trastuzumab before surgery in treating women with stage I, stage II, or stage III breast cancer.
详细描述
OBJECTIVES:
Primary
- Compare the pathologic complete response rates in women with stage I-III primary breast cancer treated with neoadjuvant epirubicin hydrochloride, cyclophosphamide, and docetaxel with versus without capecitabine followed by surgery .
- Compare the pathologic complete response rates in women with HER-2/neu-positive tumors receiving trastuzumab (Herceptin®) simultaneously with neoadjuvant epirubicin hydrochloride, cyclophosphamide, and docetaxel to women with HER-2/neu-negative tumors receiving neoadjuvant chemotherapy only.
Secondary
- Determine the toxicity of these regimens in these patients.
- Determine the disease-free (loco-regional and distant) survival and overall survival of patients treated with these regimens.
- Determine the disease-free (loco-regional and distant) survival and overall survival of patients treated with or without trastuzumab.
- Determine the breast conservation rate in patients treated with these regimens.
- Determine the frequency of the use of sentinel node biopsy for selecting patients for neoadjuvant chemotherapy.
- Compare the frequency of sentinel node biopsies at surgery after neoadjuvant chemotherapy in each arm.
- Determine the pathologic complete response rates to each regimen in the subgroup of patients with locally advanced (T4a-d, N0-3, M0) breast cancer.
- Determine the response rate (complete response, partial response, or no change) at surgery (by imaging methods and by histopathological exam) in patient subgroups according to their response after four treatments with epirubicin hydrochloride and cyclophosphamide.
- Determine the intention for the use of neoadjuvant chemotherapy, in terms of freedom from disease, avoiding mastectomy, improving breast conservation, and gaining information about efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed unilateral or bilateral primary breast cancer
- •Meets 1 of the following staging criteria:
- •Clinical stage T4 or T3 disease
- •Clinical stage T1 and pathologic stage N+ by sentinel lymph node biopsy OR clinical stage T2, N+ disease AND estrogen receptor (ER) or progesterone receptor (PR) positive tumor
- •ER and PR negative tumor (T1-4, N0-3, M0)
- •Disease confirmed by core biopsy
- •No fine-needle aspiration or incisional biopsy
- •Bidimensionally measurable disease*
- •Tumor lesion palpable and measures ≥ 2 cm OR tumor lesion ≥ 1 cm in maximum diameter by sonography
- •For inflammatory disease, extent of inflammation can be used as measurable lesion NOTE: *In patients with multifocal or multicentric breast cancer, the largest lesion should be measured
- •Candidate for adjuvant chemotherapy
- •No low- or moderate-risk patients who are doubtful candidates for adjuvant chemotherapy and do not fulfill the staging criteria
- •Known HER-2/neu status by core biopsy
- •HER-2/neu positive tumor is defined as +3 by immunohistochemistry [IHC] OR positive by fluorescence in situ hybridization (FISH)
- •No evidence of distant metastasis
- •Hormone receptor status:
- •ER- or PR-positive tumor OR ER- and PR-negative tumor
- •PATIENT CHARACTERISTICS:
- •No male patients
- •Menopausal status not specified
- •Karnofsky performance status 80-100%
- •Life expectancy ≥ 10 years (disregarding diagnosis of cancer)
- •Normal cardiac function confirmed by ECG
- •LVEF ≥ 55% by cardiac ultrasound
- •Neutrophil count ≥ 2,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 10 g/dL
- •Bilirubin normal
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- •Alkaline phosphatase (AP) ≤ 5 times ULN OR
- •AP ≤ 2.5 times ULN AND AST and/or ALT ≤ 1.5 times ULN
- •Creatinine ≤ 2 mg/dL
- •Creatinine clearance ≥ 50 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective nonhormonal contraception
- •No motor or sensory neuropathy ≥ grade 2
- •No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
- •No New York Heart Association class II-IV congestive heart failure
- •No coronary artery disease
- •No history of myocardial infarction
- •No uncontrolled arterial hypertension (i.e., blood pressure ≥ 160/90 mm Hg despite antihypertensive therapy)
- •No rhythm abnormalities requiring permanent therapy
- •No history of significant neurological or psychiatric disorders including psychotic disorders, dementia, or seizures that would preclude giving informed consent
- •No active infection
- •No active peptic ulcer
- •No unstable diabetes mellitus or insulin-dependent type II diabetes mellitus
- •No other serious illness or medical condition
- •No known hypersensitivity reaction to investigational compounds or incorporated substances
- 另有 16 项未显示
排除标准
- 未提供
结局指标
主要结局
Pathologic complete response
次要结局
未报告次要终点
研究者
研究点 (1)
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