NCT00789581已完成3 期
Phase III Study of Doxorubicin/Cyclophosphamide (AC) Followed by Ixabepilone vs. AC Followed by Paclitaxel in Patients With Triple-Negative Early-Stage Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 614
- 试验地点
- 69
- 主要终点
- Disease-free Survival
研究概览
简要总结
This is a randomized, Phase III, open-label, multicenter study.
详细描述
Patients will be randomized in a 1:1 ratio to receive one of two different treatment arms. Patients in treatment arm 1 will receive AC followed by ixabepilone. Patients in treatment arm 2 will receive AC followed by weekly paclitaxel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Female patients greater than or equal to18 years of age.
- •Histologically confirmed invasive unilateral breast cancer (regardless of
- •histology).
- •Early-stage breast cancer, defined as:
- •Node-positive disease: >0.2-mm metastasis in at least one lymph node (pN1mipN2b)OR
- •Node-negative, with primary tumor >1.0 cm (T1c-T3).
- •Definitive loco-regional surgery must have been completed as specified
- •Patients must have undergone either breast conservation surgery
- •(i.e., lumpectomy) or total mastectomy.
- •Surgical margins of the resected section must be histologically free of
- •invasive adenocarcinoma and ductal carcinoma in situ.
- •Surgical margins involved with lobular carcinoma in situ (LCIS) will not
- •be considered as a positive margin; therefore, such patients will be eligible for this study without additional resection.
- •Patients must have completed axillary lymph node sampling for the pathologic evaluation of axillary lymph nodes as specified below:
- •Sentinel node biopsy and/or either lymph node sampling procedure or axillary dissection.
- •Multicentric and multifocal invasive breast cancer is eligible if loco-regional surgery has been completed as described above.
- •Patients with synchronous bilateral cancers are eligible only if:
- •All cancers are of triple-negative phenotype, defined as ER-, PR-, HER2-.
- •Eligibility based on the highest stage grouping.
- •HER2 negative tumors. HER2 negativity must be confirmed by one of the
- •FISH-negative (FISH ratio <2.2), or
- •IHC 0-1+, or
- •IHC 2-3+ AND FISH-negative (FISH ratio <2.2).
- •Estrogen receptor negative (<10% staining by IHC for estrogen receptor).
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- •Patient must be <= 84 days from having completed definitive primary breast surgery (either lumpectomy or mastectomy).
- •MammoSite brachytherapy radiation is acceptable if it is performed
- •immediately following surgery and prior to chemotherapy. It is recommended that chemotherapy be started no earlier than 2 weeks following the removal of the MammoSite balloon catheter.
- •Adequate hematologic function, defined by:
- •Absolute neutrophil count (ANC) >1500/mm3
- •Platelet count >=100,000/mm3
- •Hemoglobin >9 g/dL
- •Adequate liver function, defined by:
- •AST and ALT <=2.5 x the upper limit of normal (ULN)
- •Total bilirubin <=1.5 x ULN (unless the patient has grade 1 bilirubin
- •elevation due to Gilbert's disease or a similar syndrome involving slow
- •conjugation of bilirubin).
- •Adequate renal function, defined by:
- •Serum creatinine <=1.5 x ULN
- •Complete staging work-up <=12 weeks prior to initiation of study treatment
- •with computed tomography (CT) scans of the chest and abdomen/pelvis (abdomen/pelvis preferred; abdomen accepted), and either a positron emission tomography (PET) scan or a bone scan.
- •Adequate cardiac function, defined by a left ventricular ejection fraction
- •(LVEF) value of >50% (or normal per institutional guidelines) by MUGA scan or echocardiogram (ECHO).
- •Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of a minor surgery (i.e., sentinel node biopsy, port-acath (placement); at least 3 weeks must have elapsed from the time of a major surgery (i.e., lumpectomy, partial or total mastectomy, axillary lymph node dissection, breast reconstruction procedure).
- •Patients with previous history of invasive cancers (including breast cancer)
- •are eligible if definitive treatment was completed more than 5 years prior to
- •initiating current study treatment, and there is no evidence of recurrent disease.
- •Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
- •Patient must be accessible for treatment and follow-up.
- •Women of childbearing potential must agree to use an acceptable method of birth control to avoid pregnancy for the duration of study treatment, and for 3 months thereafter.
- 另有 2 项未显示
排除标准
- •Women who are pregnant or breastfeeding.
- •History of previous diagnosis of invasive breast cancer (unless treated >5 years previously with no recurrence). History of previously treated ductal carcinoma in situ (DCIS) is acceptable.
- •Any evidence or suspicion of metastatic disease other than ipsilateral
- •axillary lymph nodes.
- •Any tumor >=T4 (cutaneous invasion, deep adherence, inflammatory breast cancer).
- •Previous anthracycline chemotherapy.
- •Concurrent use of CYP3A4 inhibitors from 72 hours prior to initiation of
- •study treatment until the end of treatment with ixabepilone.
- •Previous treatment for this breast cancer (including neoadjuvant
- •chemotherapy).
- •Previous cancer (with the exception of non-melanoma skin cancer or cervical carcinoma in situ) in the past 5 years (including invasive contralateral breast cancer).
- •Peripheral neuropathy of > grade 1 per NCI CTCAE v3.
- •Cardiac disease, including: congestive heart failure (CHF) > Class II per
- •New York Heart Association (NYHA) classification; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months; symptomatic CHF, unstable angina pectoris, cardiac arrhythmia, or cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- •History of hypersensitivity to CremophorEL (polyoxyethylated castor oil) or
- •a drug formulated in CremophorEL such as paclitaxel.
- •Use of any investigational agent within 30 days of administration of the first dose of study drug.
- •Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
- •Concurrent severe, uncontrolled infection or intercurrent illness including,
- •but not limited to, ongoing or active infection, or psychiatric illness/social
- •situations that would limit compliance with study requirements.
- •Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
- •Inability to comply with study and/or follow-up procedures.
研究组 & 干预措施
Doxorubicin/cyclophosphamide, ixabepilone
Experimental
Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by ixabepilone at 40 mg/m2 given for 4 cycles of 21 days each.
干预措施: Doxorubicin (Drug)
Doxorubicin/cyclophosphamide, ixabepilone
Experimental
Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by ixabepilone at 40 mg/m2 given for 4 cycles of 21 days each.
干预措施: Cyclophosphamide (Drug)
Doxorubicin/cyclophosphamide, ixabepilone
Experimental
Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by ixabepilone at 40 mg/m2 given for 4 cycles of 21 days each.
干预措施: Ixabepilone (Ixempra) (Drug)
Doxorubicin/cyclophosphamide, paclitaxel
Active Comparator
Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by paclitaxel at 80 mg/m2 weekly for 12 weeks.
干预措施: Doxorubicin (Drug)
Doxorubicin/cyclophosphamide, paclitaxel
Active Comparator
Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by paclitaxel at 80 mg/m2 weekly for 12 weeks.
干预措施: Cyclophosphamide (Drug)
Doxorubicin/cyclophosphamide, paclitaxel
Active Comparator
Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by paclitaxel at 80 mg/m2 weekly for 12 weeks.
干预措施: Paclitaxel (Taxol) (Drug)
结局指标
主要结局
Disease-free Survival
时间窗: up to 5.25 years (63 months)
The percentage of participants with disease-free survival at 3 and 5 years. Disease-free survival (DFS) is measured from the time between randomization and the date of first documented disease recurrence, or death from any cause.
次要结局
- Overall Survival(up to 5.25 years (63 months))
研究者
研究点 (69)
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