Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable and/or Locally Advanced Breast Cancer. The INTENS Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 24
- 主要终点
- The pathologic complete response rate to neoadjuvant chemotherapy.
研究概览
简要总结
2 different treatment schedules may be used for neoadjuvant chemotherapy in breast cancer using adriamycin, cyclophosphamide and taxotere. The most optimal sequence- concurrent or sequential- is however unclear. The aim of the study is to compare the efficacy and tolerability of neoadjuvant chemotherapy with AC followed by T(adriamycin, cyclophosphamide, taxotere) versus TAC ( with upfront T) in patient with large resectable or locally advanced breast cancer.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women presenting with large resectable or locally advanced breast cancer (T2 ≥3 cm, T3, or T4, and/or LN positive)
- •Measurable disease (breast and/or lymph nodes)
- •No prior surgery other than biopsy and no prior chemotherapy or radiation therapy
- •Age ≥18 years and age ≤70 years
- •Karnofsky Performance score ≥70%
- •Estrogen and/or progesterone receptor analysis performed on the primary tumour in the biopsy material
- •In case the tumor is ER/PgR ³ 50% positive, (neo)adjuvant hormonal therapy in stead of chemotherapy should be considered (e.g. in TEAM II study)
- •Her2/neu receptor analysis performed on the primary tumour in the biopsy material
- •Adequate bone marrow function (within 14 days prior to registration): WBC ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
- •Adequate liver function (within 4 weeks prior to start treatment): bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL
- •Adequate renal function (within 4 weeks prior to start treatment): the calculated creatinine clearance should be ≥50 mL/min
- •Patients must be accessible for treatment and follow-up
- •Written informed consent according to the local Ethics Committee requirements
排除标准
- •Patients with advanced pulmonary disease of any cause (oxygen dependent)- Peripheral neuropathy > grade 2 whatever the cause
- •Serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrythmias
- •Evidence of distant metastases (M1)
- •Patients with a history of breast cancer
- •Patients with a history of another malignancy (except basal cell skin carcinoma and carcinoma-in-situ of the uterine cervix) within 5 years of study entry- Pregnant or lactating women, or potentially fertile women not using adequate contraception
研究组 & 干预措施
A
Cycles 1-4 q 3 weeks: doxorubicin plus cyclophosphamide Cycles 5-8 q 3 weeks: docetaxel
干预措施: Doxorubicin (Drug)
A
Cycles 1-4 q 3 weeks: doxorubicin plus cyclophosphamide Cycles 5-8 q 3 weeks: docetaxel
干预措施: Cyclophosphamide (Drug)
A
Cycles 1-4 q 3 weeks: doxorubicin plus cyclophosphamide Cycles 5-8 q 3 weeks: docetaxel
干预措施: Docetaxel (Drug)
B
Cycles 1-6 q 3 weeks: doxorubicin, cyclophosphamide and docetaxel
干预措施: Doxorubicin (Drug)
B
Cycles 1-6 q 3 weeks: doxorubicin, cyclophosphamide and docetaxel
干预措施: Cyclophosphamide (Drug)
B
Cycles 1-6 q 3 weeks: doxorubicin, cyclophosphamide and docetaxel
干预措施: Docetaxel (Drug)
结局指标
主要结局
The pathologic complete response rate to neoadjuvant chemotherapy.
次要结局
- The delivered chemotherapy dose and dose-intensity of both chemotherapy regimens
- The tolerability (grade 3/4 CTC toxicities) of both chemotherapy regimens.
- The clinical responses of neoadjuvant chemotherapy correlated to pathological responses after neoadjuvant chemotherapy.
- The value of breast MRI in evaluating response to neoadjuvant chemotherapy as compared to clinical palpation, ultrasound techniques and histo-pathological outcome.
- The false-negative rate of the sentinel node biopsy after neoadjuvant chemotherapy.
- The disease-free and overall survival after 3 and 5 years follow-up.
- The relation between pCR and DFS/OS.
- The feasibility of the criteria for reporting pathological tumour response in surgical breast and axillary node resection specimens.
- The prognostic and predictive value of tumour- and molecular markers, including ER, PgR, c-erbB2, microarray and other tumour characteristic analyses.