Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: Docetaxel Drug: Cyclophosphamide | Phase 3 |
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 |
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)
|
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Zhimin Shao, MD, PhD | +86-021-64175590 ext 8808 | zhimingshao@yahoo.com |
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 |
Principal Investigator: | Zhimin Shao, MD, PhD | Fudan University |
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | March 31, 2019 | ||||||
First Posted Date ICMJE | April 24, 2019 | ||||||
Last Update Posted Date | March 9, 2020 | ||||||
Actual Study Start Date ICMJE | July 3, 2018 | ||||||
Estimated Primary Completion Date | July 1, 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Disease free survival [ Time Frame: 5 year ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
|
||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Study Comparing 4 Cycles With 6 Cycles of TC (Docetaxel+Cyclophosphamide) Adjuvant Chemotherapy for 1-3 Lymph Node Positive ER+/HER2- Early Breast Cancer | ||||||
Official Title ICMJE | 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 | ||||||
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. | ||||||
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. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | 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). Primary Purpose: Treatment |
||||||
Condition ICMJE | Breast Cancer | ||||||
Intervention ICMJE |
|
||||||
Study Arms ICMJE |
|
||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
2172 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | July 1, 2024 | ||||||
Estimated Primary Completion Date | July 1, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender ICMJE |
|
||||||
Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
|
||||||
Listed Location Countries ICMJE | China | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03926091 | ||||||
Other Study ID Numbers ICMJE | CLOVER | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
|
||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Zhimin Shao, Fudan University | ||||||
Study Sponsor ICMJE | Fudan University | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
|
||||||
PRS Account | Fudan University | ||||||
Verification Date | March 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |