This is a prospective, multisite, randomized, open-label Phase III clinical trial (CLOVER study) comparing 4 cycles with 6 cycles of TC (docetaxel+cyclophosphamide) adjuvant chemotherapy for 1-3 positive lymph node, ER+/HER2- early breast cancer patients.
While TC (docetaxel+cyclophosphamide) adjuvant chemotherapy is one of the preferred regimens for early breast cancer, we have yet to determine the optimum number of cycles for TC adjuvant chemotherapy. In this prospective, open-label clinical trial, estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer patients with 1-3 positive lymph nodes will be randomized into either 4 cycles or 6 cycles of TC adjuvant chemotherapy. The safety and efficacy of each group will be assessed through disease-free survival (DFS), invasive disease free survival (iDFS), distant disease free survival (DDFS), overall survival (OS) and adverse effects (AE) as graded by Common Terminology Criteria for Adverse Events (CTCAE) 4.0.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,172
Docetaxel chemotherapy (injection)
Cyclophosphamide chemotherapy (injection)
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGFujian Medical University Union Hospital
Invasive disease free survival
Time frame: 5 year
disease free survival
Time frame: 5 years
distant disease free survival
Time frame: 5 years
overall survival
Time frame: 5 years
adverse effects
Time frame: 5 years
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Fuzhou, Fujian, China
Sun Yet-Sen Memorial Hospital, Sun Yet-Sen University
Guangzhou, Guangdong, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGThe First Bethune Hospital of Jilin University (The First Hospital of Jilin University)
Changchun, Jilin, China
RECRUITINGThe Second Hospital of Dalian Medical University
Dalian, Liaoning, China
RECRUITINGThe First Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGThe Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
RECRUITINGOB/GYN Hospital of Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGFudan University Shanghai Cancer Hospital
Shanghai, Shanghai Municipality, China
RECRUITING...and 4 more locations