Adjuvant Treatment of EC Followed by Taxane +/- Carboplatin in Triple-Negative Breast Cancer

Breast Neoplasm Clinical Trial

— TCTN  

Official title:

Epirubicin-Cyclophosphamide Followed by Taxanes or Taxanes Plus Carboplatin in Triple-Negative Breast Cancer：A Prospective, Randomized, Phase III Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02455141
• Other study ID #: RJBC1501
• Status: Recruiting
• Phase: Phase 3
• Start date: July 2015
• Est. completion date: December 2023

Study information

• Verified date: March 2022
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Xiaosong Chen, Dr.
• Phone: +8621-64370045
• Email: chenxiaosong0156[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study plans to enroll triple-negative breast cancer patients who have complete tumor removal. Patients are randomized to receive either EC-wP/T or EC-wP/TCb adjuvant chemotherapy. For triple-negative breast cancer, a subgroup of triple-negative breast cancer has DNA repairement deficiency and adding carboplatin to paclitaxel may improve DFS on the basis of weekly paclitaxel adjuvant chemotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 970
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Epirubicin plus Cyclophosphamide
Epirubicin 90mg/m2, d1, q3w*4 Cyclophosphamide: 600mg/m2, d1, q3w*4
• Taxanes
Paclitaxel: 80mg/m2, d1, qw*12 or Docetaxel: 80-100mg/m2,d1,q3w*4
• Taxanes plus Carboplatin
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

Locations

Country	Name	City	State
China	Foshan No.1 People's Hospital	Foshan	Guangdong
China	Fuding Hospital	Fuding	Fujian
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Guangdong Maternal and Child Health Care Hospital	Guangzhou	Guangdong
China	Hangzhou Cancer Hospital	Hangzhou	Zhejiang
China	Zhejiang Provincial Hospital of TCM	Hangzhou	Zhejiang
China	Cancer Hospital Affiliated to Harbin Medical University	Harbin	Heilongjiang
China	Jiangsu Jiangyin People's Hospital	Jiangyin	Jiangsu
China	Jiaxin Maternal and Child Health Care Hospital	Jiaxin	Zhejiang
China	Lishui People's Hospital	Lishui	Zhejiang
China	Ningbo First Hospital	Ningbo	Zhejiang
China	Ningbo Medical Treatment Center Lihuili Hospital	Ningbo	Zhejiang
China	Ningbo Women and Children's Hospital	Ningbo	Zhejiang
China	Quanzhou First Hospital	Quanzhou	Fujian
China	Rui'an People's Hospital	Rui'an	Zhejiang
China	Central Hospital of Huangpu District, Shanghai	Shanghai	Shanghai
China	Obstetrics & Gynecology Hospital of Fudan University	Shanghai	Shanghai
China	Shanghai International Peace Maternal and child health care hospital	Shanghai	Shanghai
China	Shanghai JiaoTong University School of Medicine, Ruijin Hospital	Shanghai	Shanghai
China	The Ninth People's Hospital of Shanghai	Shanghai	Shanghai
China	Shaoxing No.2 Hospital	Shaoxing	Zhejiang
China	Shaoxing Shangyu People's Hospital	Shaoxing	Zhejiang
China	The First People's Hospital of Wujiang District	Suzhou	Jiangsu
China	Taizhou Central Hospital	Taizhou	Zhejiang
China	Wenzhou People's Hospital	Wenzhou	Zhejiang
China	Yancheng Hospital of TCM	Yancheng	Jiangsu
China	Zhoushan Hospital	Zhoushan	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (5)

Chen 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. — View Citation

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. — View Citation

Martín M, Rodríguez-Lescure A, Ruiz A, Alba E, Calvo L, Ruiz-Borrego M, Santaballa A, Rodríguez CA, Crespo C, Abad M, Domínguez S, Florián J, Llorca C, Méndez M, Godes M, Cubedo R, Murias A, Batista N, García 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. — View Citation

Sikov 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. — View Citation

von Minckwitz G, Schneeweiss A, Loibl S, Salat C, Denkert C, Rezai M, Blohmer JU, Jackisch C, Paepke S, Gerber B, Zahm DM, Kümmel 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	to compare the disease-free survival among two treatment arms	3 years
Secondary	Overall Survival	to compare the overall survival among two treatment arms	3 years
Secondary	Incidence of neutropenia fever	to compare the neutropenia fever among two treatment arms	up to 7 months
Secondary	Incidence of grade 3-4 side effects	to compare the grade 3-4 side effects among two treatment arms	up to 7 months