Adjuvant Treatment of EC Followed by Taxane +/- Carboplatin in Triple-Negative Breast Cancer
TCTN
Epirubicin-Cyclophosphamide Followed by Taxanes or Taxanes Plus Carboplatin in Triple-Negative Breast Cancer：A Prospective, Randomized, Phase III Trial
1 other identifier
interventional
786
1 country
27
Brief Summary
To compare disease-free survival (DFS) rate of adjuvant chemotherapy epirubicin-cyclophosphamide followed by weekly paclitaxel or docetaxel (EC-T), or weekly paclitaxel or docetaxel-carboplatin (EC-TCb) in triple-negative breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2016
Longer than P75 for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2030
July 11, 2025
July 1, 2025
11 years
May 2, 2015
July 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free survival
The time from randomization to local or regional recurrence, distant metastases, other non-breast secondary primary malignancies, contralateral breast cancer, or death due to any cause, whichever occurs first.
From time of randomization to 5 years after enrollment.
Secondary Outcomes (3)
Distant disease-free survival
From time of randomization to 5 years after enrollment.
Overall Survival
From time of randomization to 5 years after enrollment.
Incidence of adverse events
From randomization to four weeks after end of study treatment
Study Arms (2)
Taxanes
ACTIVE COMPARATOREpirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel
Taxanes plus carboplatin
EXPERIMENTALEpirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel + Carboplatin
Interventions
Epirubicin 90mg/m2, d1, q3w\*4 Cyclophosphamide: 600mg/m2, d1, q3w\*4
Paclitaxel: 80mg/m2, d1,d8,d15, q4w\*4 Carboplatin AUC=2, d1,d8,d15, q4w\*4 or Docetaxel: 75mg/m2,d1,q3w\*4 plus Carboplatin AUC=5-6, d1, q3w\*4
Eligibility Criteria
You may qualify if:
- Histologically confirmed adenocarcinoma of the breast, completely tumor removal by either modified radical mastectomy or local excision plus axillary lymph node dissection (i.e., breast conservation therapy) or sentinel node biopsy. (Tumor-free margins at least 1 mm for both invasive and noninvasive carcinoma except for lobular carcinoma in situ (less than 1 mm allowed);
- Tumor specimens are available for estrogen receptor (ER), progesterone receptor (PgR) and Her2 (human epidermal-growth-factor receptor 2) detection, patients should be with triple negative breast cancer. Triple-negative disease is defined as ER \<10% positivity, PgR \<10% positivity, and negativity for Her2 (IHC (immunohistochemistry) 0-1+ or FISH (fluorescence in situ hybridization) negative);
- Adequate bone marrow function
- Adequate liver and renal function
- Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1;
- Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study;
- Written informed consent according to the local ethics committee requirements.
You may not qualify if:
- Prior systemic of breast cancer, including chemotherapy;
- Metastatic breast cancer;
- With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma;
- Patients with medical conditions that indicate intolerant to adjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitus, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease;
- Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive;
- Contraindication for using dexamethasone;
- History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP\>180 mmHg or diastolic BP\>100 mmHg);
- Has peripheral neuropathy no less than grade 1;
- Patient is pregnant or breast feeding;
- Patients with psychiatric disorder or other diseases leading to incompliance to the therapy;
- Known severe hypersensitivity to any drugs in this study;
- Treatment with any investigational drugs within 30 days before the beginning of study treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Fuding Hospital
Fuding, Fujian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
Quanzhou First Hospital
Quanzhou, Fujian, China
Foshan No.1 People's Hospital
Foshan, Guangdong, 528000, China
Guangdong Maternal and Child Health Care Hospital
Guangzhou, Guangdong, 510000, China
Cancer Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang, 150081, China
Jiangsu Jiangyin People's Hospital
Jiangyin, Jiangsu, 214400, China
The First People's Hospital of Wujiang District
Suzhou, Jiangsu, 215200, China
Yancheng Hospital of TCM
Yancheng, Jiangsu, China
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200021, China
Shanghai JiaoTong University School of Medicine, Ruijin Hospital
Shanghai, Shanghai Municipality, 200025, China
Central Hospital of Huangpu District, Shanghai
Shanghai, Shanghai Municipality, China
Shanghai International Peace Maternal and child health care hospital
Shanghai, Shanghai Municipality, China
The Ninth People's Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial Hospital of TCM
Hangzhou, Zhejiang, China
Jiaxin Maternal and Child Health Care Hospital
Jiaxin, Zhejiang, 310000, China
Lishui People's Hospital
Lishui, Zhejiang, 310000, China
Ningbo Medical Treatment Center Lihuili Hospital
Ningbo, Zhejiang, 315000, China
Ningbo Women and Children's Hospital
Ningbo, Zhejiang, 315000, China
Ningbo First Hospital
Ningbo, Zhejiang, China
Rui'an People's Hospital
Rui’an, Zhejiang, 325200, China
Shaoxing Shangyu People's Hospital
Shaoxing, Zhejiang, 312300, China
Shaoxing No.2 Hospital
Shaoxing, Zhejiang, China
Taizhou Central Hospital
Taizhou, Zhejiang, 318000, China
Wenzhou People's Hospital
Wenzhou, Zhejiang, China
Zhoushan Hospital
Zhoushan, Zhejiang, 316000, China
Related Publications (6)
Hayes DF, Thor AD, Dressler LG, Weaver D, Edgerton S, Cowan D, Broadwater G, Goldstein LJ, Martino S, Ingle JN, Henderson IC, Norton L, Winer EP, Hudis CA, Ellis MJ, Berry DA; Cancer and Leukemia Group B (CALGB) Investigators. HER2 and response to paclitaxel in node-positive breast cancer. N Engl J Med. 2007 Oct 11;357(15):1496-506. doi: 10.1056/NEJMoa071167.
PMID: 17928597BACKGROUNDMartin M, Rodriguez-Lescure A, Ruiz A, Alba E, Calvo L, Ruiz-Borrego M, Santaballa A, Rodriguez CA, Crespo C, Abad M, Dominguez S, Florian J, Llorca C, Mendez M, Godes M, Cubedo R, Murias A, Batista N, Garcia MJ, Caballero R, de Alava E. Molecular predictors of efficacy of adjuvant weekly paclitaxel in early breast cancer. Breast Cancer Res Treat. 2010 Aug;123(1):149-57. doi: 10.1007/s10549-009-0663-z.
PMID: 20037779BACKGROUNDSikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM, Kuzma CS, Pluard TJ, Somlo G, Port ER, Golshan M, Bellon JR, Collyar D, Hahn OM, Carey LA, Hudis CA, Winer EP. Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once-per-week paclitaxel followed by dose-dense doxorubicin and cyclophosphamide on pathologic complete response rates in stage II to III triple-negative breast cancer: CALGB 40603 (Alliance). J Clin Oncol. 2015 Jan 1;33(1):13-21. doi: 10.1200/JCO.2014.57.0572. Epub 2014 Aug 4.
PMID: 25092775BACKGROUNDvon Minckwitz G, Schneeweiss A, Loibl S, Salat C, Denkert C, Rezai M, Blohmer JU, Jackisch C, Paepke S, Gerber B, Zahm DM, Kummel S, Eidtmann H, Klare P, Huober J, Costa S, Tesch H, Hanusch C, Hilfrich J, Khandan F, Fasching PA, Sinn BV, Engels K, Mehta K, Nekljudova V, Untch M. Neoadjuvant carboplatin in patients with triple-negative and HER2-positive early breast cancer (GeparSixto; GBG 66): a randomised phase 2 trial. Lancet Oncol. 2014 Jun;15(7):747-56. doi: 10.1016/S1470-2045(14)70160-3. Epub 2014 Apr 30.
PMID: 24794243BACKGROUNDChen XS, Yuan Y, Garfield DH, Wu JY, Huang O, Shen KW. Both carboplatin and bevacizumab improve pathological complete remission rate in neoadjuvant treatment of triple negative breast cancer: a meta-analysis. PLoS One. 2014 Sep 23;9(9):e108405. doi: 10.1371/journal.pone.0108405. eCollection 2014.
PMID: 25247558BACKGROUNDChen X, Huang J, Shi H, Zhu J, Wu W, Ye G, He Q, Shi Y, Zhang A, Xie X, Wang X, Chen X, Wu W, Wu J, Li Z, Li Z, Dai Y, Ren W, Shao Q, Chen Y, Zeng Y, Zhang F, Dong S, Pegram MD, Shen K. Adjuvant Epirubicin Plus Cyclophosphamide Followed by Taxanes With or Without Carboplatin in Early-Stage Triple-Negative Breast Cancer (RJBC 1501): A Randomized Phase III Trial. J Clin Oncol. 2026 Jan 20;44(3):143-152. doi: 10.1200/JCO-25-02412. Epub 2025 Dec 9.
PMID: 41365333DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kunwei Shen, professor
Affiliated Ruijin Hospital of Shanghai JiaoTong University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
May 2, 2015
First Posted
May 27, 2015
Study Start
March 1, 2016
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2030
Last Updated
July 11, 2025
Record last verified: 2025-07