NCT02441933进行中（未招募）3 期
A Randomized, Multicenter, Open-label, Phase III Trial Comparing Anthracyclines Followed by Taxane Versus Anthracyclines Followed by Taxane Plus Carboplatin as (Neo) Adjuvant Therapy in Patients With Triple-negative Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 878
- 试验地点
- 21
- 主要终点
- 5-year event-free survival (EFS)
研究概览
简要总结
This is a randomized, open-label, multicenter, phase III study comparing anthracyclines followed by taxane to anthracyclines followed by taxane plus carboplatin as (neo)adjuvant therapy in patients with triple-negative breast cancer.
Patients with stage II/III operable triple-negative breast cancer are eligible. Patients who need adjuvant chemotherapy after breast surgery as well as patients who need neoadjuvant chemotherapy for TNBC are eligible.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients who are >18 years of age
- •ECOG 0 or 1
- •The tumor must be invasive carcinoma of the breast on histologic examination
- •The tumor must have been determined to be HER2-negative, as follows:
- •IHC 0 or 1+; or
- •IHC 2+ and ISH non-amplified, with a ratio of <2.0, and if reported, an average HER2 gene copy number of <6 signals/cell; or
- •ISH non-amplified without IHC
- •The tumor must have been determined to be ER- and PR-negative, as assessed by the current ASCO/CAP guidelines.
- •All of the following staging criteria (AJCC 7th edition) must be met:
- •Lymph node-positive disease: cytologically positive in the neoadjuvant group* and pathologically positive in the adjuvant group
- •If the lymph node is cytologically or pathologically negative, the tumor size must be >2.0 cm (* In the neoadjuvant group, if there is evidence of suspicious axillary lymph nodes at the baseline imaging study or physical examination, then FNA or core biopsy is required to confirm the nodal status)
- •The patient must have undergone either a mastectomy or lumpectomy in the adjuvant group
- •The patient must have completed one of the nodal surgery procedures listed below in the adjuvant group:
- •Sentinel lymph node biopsy (SLNB) alone:
- •V If pathologic nodal staging based on SLNB is pN0 V If pathologic nodal staging based on SLNB is 1 or 2 positive nodes, the primary tumor must be T1 or T2 by pathologic evaluation and lumpectomy and the nodal involvement must be limited to 1 or 2 positive nodes
- •SLNB followed by removal of additional non-sentinel LNs if the SLN is positive; or
- •Axillary lymphadenectomy with or without SLNB (In the neoadjuvant group, if baseline LN NAB or core biopsy is positive, ALND should be performed) 9) LVEF assessment by echocardiography or MUGA scan must be >50%, regardless of the cardiac imaging facility's lower limit of normal 10) The patient must have adequate hepatic, renal, and bone marrow function;
- •Bone marrow function Hb: ≥ 10.0 g/dL ANC: ≥ 1,500/µL Platelet count: ≥ 10 × 10⁴/µL
- •Renal function Creatinine: ≤ 1.5 × UNL or Creatine clearance (Ccr) >50 ml/min by the Cockcroft formula
- •Hepatic function Total Bilirubin: ≤ 1.5 × UNL AST/ALT: ≤ 2.5 × UNL 10) Ability and willingness to comply with the study visits, treatment, testing, and with the protocol, as per investigator's judgment
排除标准
- •Any prior systemic treatment for primary invasive breast cancer
- •cT4 or pT4 tumors including inflammatory breast cancer
- •Occult breast cancer
- •Evidence of metastatic breast cancer
- •Patients with second primary cancer; EXCEPTIONS: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, DCIS of the breast, thyroid cancer with a size of <2 cm (papillary, follicular, and medullary type), and other solid tumors curatively treated with no evidence of disease for >5 years prior to randomization.
- •Simultaneous bilateral breast cancer
- •Patients considered a poor medical risk due to a serious, uncontrolled medical disorder or uncontrolled infection.
- •Pregnant or breastfeeding women
研究组 & 干预措施
control group
Active Comparator
干预措施: Taxane (Drug)
carboplatin group
Experimental
干预措施: taxane plus carboplatin (Drug)
结局指标
主要结局
5-year event-free survival (EFS)
时间窗: 5 year
time from Cycle1 Day1 to the occurrence of the following events : loco-regional recurrence, distant recurrence, death from any cause, contralateral invasive breast cancer, second primary cancer, and cancer after surgery (not R0 resection), definitive disease progression during neoadjuvant chemotherapy, inoperable status after neoadjuvant chemotherapy
次要结局
- overall survival(5 year)
- Distant recurrence free survival(5 year)
- loco-regional recurrence free survival(5 year)
- pathologic complete response rate(5 year)
研究者
研究点 (21)
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