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Study Comparing 4 Cycles With 6 Cycles of TC (Docetaxel+Cyclophosphamide) Adjuvant Chemotherapy for 1-3 Lymph Node Positive ER+/HER2- Early Breast Cancer (CLOVER)

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ClinicalTrials.gov Identifier: NCT03926091
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Zhimin Shao, Fudan University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Docetaxel Drug: Cyclophosphamide Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Arm 1:6 cycles of TC (Docetaxel 75 mg/m^2 ivgtt d1+Cyclophosphamide 600 mg/m^2 iv d1, 21 days per cycle).

Arm 2:4 cycles of TC (Docetaxel 75 mg/m^2 ivgtt d1+Cyclophosphamide 600 mg/m^2 iv d1, 21 days per cycle).

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Lymph Node Positive ER+/HER2- Early Breast Cancer
Actual Study Start Date : July 3, 2018
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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).
Drug: Docetaxel
Docetaxel chemotherapy (injection)

Drug: Cyclophosphamide
Cyclophosphamide chemotherapy (injection)

Active Comparator: 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).
Drug: Docetaxel
Docetaxel chemotherapy (injection)

Drug: Cyclophosphamide
Cyclophosphamide chemotherapy (injection)




Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 5 year ]

Secondary Outcome Measures :
  1. invasive disease free survival [ Time Frame: 5 years ]
  2. distant disease free survival [ Time Frame: 5 years ]
  3. overall survival [ Time Frame: 5 years ]
  4. adverse effects [ Time Frame: 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. women aged 18-70 years old;
  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:

  1. Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy);
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926091


Contacts
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Contact: Zhimin Shao, MD, PhD +86-021-64175590 ext 8808 zhimingshao@yahoo.com

Locations
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China, Chongqing
Chongqing Cancer Hospital Recruiting
Chongqing, Chongqing, China, 400030
Contact: Xiaohua Zeng, M.D.    +86-023-65311341      
China, Fujian
Fujian Medical University Union Hospital Recruiting
Fuzhou, Fujian, China, 350001
Contact: Chuangui Song, M.D,    +86-591-83357896      
China, Guangdong
Sun Yet-Sen Memorial Hospital, Sun Yet-Sen University Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Qiang Liu, M.D.    +86-020-81332199      
China, Heilongjiang
Harbin Medical University Cancer Hospital Recruiting
Harbin, Heilongjiang, China, 150081
Contact: Zhigao Li, M.D.    +86-451-86298000      
China, Jilin
The First Bethune Hospital of Jilin University (The First Hospital of Jilin University) Recruiting
Changchun, Jilin, China, 130021
Contact: Zhimin Fan, M.D.    +86-431-88782222      
China, Liaoning
The Second Hospital of Dalian Medical University Recruiting
Dalian, Liaoning, China, 116027
Contact: Man Li, M.D.    +86-411-84671291      
The First Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110001
Contact: Feng Jin, M.D.    +86-024-83283333      
China, Shandong
The Affiliated Hospital of Qingdao University Recruiting
Qingdao, Shandong, China, 266000
Contact: Haibo Wang, M.D.         
China, Shanghai
OB/GYN Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 200011
Contact: Kejin Wu, M.D.    +86-021-33189900      
Fudan University Shanghai Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Zhimin Shao, M.D.    +86-021-64175590 ext 8808    zhimingshao@yahoo.com   
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300052
Contact: Jin Zhang, M.D.         
China, Zhejiang
The First Affiliated Hospital, ZheJiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Peifen Fu, M.D.       zdyy6616@126.com   
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Hongjian Yang, M.D.    +86-571-88122222    zjszlyy@zjcc.org.cn   
The Second Affiliated Hospital of Zhejiang University School of Medicine Recruiting
Hanzhou, Zhejiang, China, 310009
Contact: Jian Huang, M.D.    +86-571-87783777      
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Zhimin Shao, MD, PhD Fudan University
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Responsible Party: Zhimin Shao, Chief Physician, Fudan University
ClinicalTrials.gov Identifier: NCT03926091    
Other Study ID Numbers: CLOVER
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Zhimin Shao, Fudan University:
docetaxel
cyclophosphamide
adjuvant chemotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators