Study Comparing 4 Cycles With 6 Cycles of TC (Docetaxel+Cyclophosphamide) Adjuvant Chemotherapy for 1-3 Lymph Node Positive ER+/HER2- Early Breast Cancer
NCT ID: NCT03926091
Last Updated: 2023-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
2172 participants
INTERVENTIONAL
2019-04-01
2025-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Arm 2：4 cycles of TC (Docetaxel 75 mg/m\^2 ivgtt d1+Cyclophosphamide 600 mg/m\^2 iv d1, 21 days per cycle).
TREATMENT
NONE
Study Groups
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4 cycles of TC adjuvant chemotherapy
4 cycles of TC (Docetaxel 75 mg/m\^2 ivgtt d1+Cyclophosphamide 600 mg/m\^2 iv d1, 21 days per cycle).
Docetaxel
Docetaxel chemotherapy (injection)
Cyclophosphamide
Cyclophosphamide chemotherapy (injection)
6 cycles of TC adjuvant chemotherapy
6 cycles of TC (Docetaxel 75 mg/m\^2 ivgtt d1+Cyclophosphamide 600 mg/m\^2 iv d1, 21 days per cycle).
Docetaxel
Docetaxel chemotherapy (injection)
Cyclophosphamide
Cyclophosphamide chemotherapy (injection)
Interventions
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Docetaxel
Docetaxel chemotherapy (injection)
Cyclophosphamide
Cyclophosphamide chemotherapy (injection)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient has localized invasive breast carcinoma with1-3 positive lymph nodes, and is ER+/HER2- confirmed by histopathology after early breast cancer surgery（HER2-negative breast cancer (based on most recently analyzed biopsy) defined as a negative in situ hybridization test or an Immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH) , or Silver in situ hybridization (SISH)) test is required by local laboratory testing.), with at least one of the following conditions: (1) histological grade III; (2) Ki67 ≥ 30%; (3) progesterone receptor (PR) ≤ 20% positive; (4) age less than 35 years; (5) extensive vascular tumor thrombus; (6) multigene detection recurrence score (RS) \>25;
3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
4. Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 \* 109 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤ 1×ULN，and with endogenous creatinine clearance rate of \>50 ml/min (Cockcroft-Gault formula).
5. Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up.
Exclusion Criteria
2. Has bilateral breast cancer;
3. Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
4. Has metastatic (Stage 4) breast cancer;
5. Has any \>T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer);
6. Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives;
7. Patients participating in other clinical trials at the same time;
8. Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) \< 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure\>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;
9. Has known allergy to taxane and excipients.
10. Has severe or uncontrolled infection;
11. Has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders;
12. the researchers judged patients to be unsuitable for the study.
18 Years
70 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhimin Shao
Chief Physician
Principal Investigators
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Zhimin Shao, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Sun Yet-Sen Memorial Hospital, Sun Yet-Sen University
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Bethune Hospital of Jilin University (The First Hospital of Jilin University)
Changchun, Jilin, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
OB/GYN Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Hospital
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, ZheJiang University
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hanzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Xiaohua Zeng, M.D.
Role: primary
Chuangui Song, M.D,
Role: primary
Qiang Liu, M.D.
Role: primary
Zhigao Li, M.D.
Role: primary
Zhimin Fan, M.D.
Role: primary
Man Li, M.D.
Role: primary
Feng Jin, M.D.
Role: primary
Haibo Wang, M.D.
Role: primary
Kejin Wu, M.D.
Role: primary
Jin Zhang, M.D.
Role: primary
Jian Huang, M.D.
Role: primary
Other Identifiers
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CLOVER
Identifier Type: -
Identifier Source: org_study_id
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