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

March 28, 2022 updated by: Kunwei Shen, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

970

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuding, Fujian, China
        • Recruiting
        • Fuding Hospital
        • Contact:
          • Yongan Chen
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
          • Xiangjin Chen, MD.
      • Quanzhou, Fujian, China
        • Recruiting
        • Quanzhou First Hospital
        • Contact:
          • Debo Chen
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Recruiting
        • Foshan No.1 people's hospital
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Guangdong Maternal and Child Health Care Hospital
        • Contact:
          • Anqin Zhang, MD
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Cancer Hospital Affiliated to Harbin Medical University
        • Contact:
          • Guoqiang Zhang
    • Jiangsu
      • Jiangyin, Jiangsu, China, 214400
        • Recruiting
        • Jiangsu Jiangyin People's Hospital
        • Contact:
          • Qing Shao, MD.
      • Suzhou, Jiangsu, China, 215200
        • Recruiting
        • The First People's Hospital of Wujiang District
        • Contact:
          • Xiaodong Wang, MD.
      • Yancheng, Jiangsu, China
        • Recruiting
        • Yancheng Hospital of TCM
        • Contact:
          • Wu Jiang
    • Shanghai
      • Shanghai, Shanghai, China, 200021
        • Recruiting
        • Obstetrics & Gynecology Hospital of Fudan University
        • Contact:
          • Kejin Wu, MD.
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Shanghai Jiaotong University school of Medicine, Ruijin Hospital
        • Contact:
      • Shanghai, Shanghai, China
        • Recruiting
        • Central Hospital of Huangpu District, Shanghai
        • Contact:
          • Jialin Bao, MD.
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai International Peace Maternal and child health care hospital
        • Contact:
          • QI He, MD.
      • Shanghai, Shanghai, China
        • Not yet recruiting
        • The Ninth People's Hospital of Shanghai
        • Contact:
          • Shanyu Guo, MD.
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Hangzhou Cancer Hospital
        • Contact:
          • Meili Wang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Provincial Hospital of TCM
        • Contact:
          • Xiaohong Xie
      • Jiaxin, Zhejiang, China, 310000
        • Recruiting
        • Jiaxin Maternal and Child Health Care Hospital
        • Contact:
          • Juanying Zhu, MD
      • Lishui, Zhejiang, China, 310000
        • Recruiting
        • Lishui People's Hospital
        • Contact:
          • Yong Shi, MD
      • Ningbo, Zhejiang, China
        • Recruiting
        • Ningbo First Hospital
        • Contact:
          • Yu Guo
      • Ningbo, Zhejiang, China, 315000
        • Recruiting
        • Ningbo Medical Treatment Center Lihuili Hospital
        • Contact:
          • Weizhu Wu, MD.
      • Ningbo, Zhejiang, China, 315000
        • Recruiting
        • Ningbo Women And Children's Hospital
        • Contact:
          • Zhanwen Li, MD.
      • Rui'an, Zhejiang, China, 325200
        • Recruiting
        • Rui'an People's Hospital
        • Contact:
          • Weili Wu
      • Shaoxing, Zhejiang, China, 312300
        • Recruiting
        • Shaoxing Shangyu People's Hospital
        • Contact:
          • Weili Ren
      • Shaoxing, Zhejiang, China
        • Recruiting
        • Shaoxing No.2 Hospital
        • Contact:
          • Zhian Li
      • Taizhou, Zhejiang, China, 318000
        • Recruiting
        • Taizhou Central Hospital
        • Contact:
          • Yuechu Dai, MD.
      • Wenzhou, Zhejiang, China
        • Recruiting
        • Wenzhou People's Hospital
        • Contact:
          • Yong Zeng
      • Zhoushan, Zhejiang, China, 316000
        • Recruiting
        • Zhoushan hospital
        • Contact:
          • Xia Qiu, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Taxanes
Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel
Drug: Epirubicin plus Cyclophosphamide
Epirubicin 90mg/m2, d1, q3w*4 Cyclophosphamide: 600mg/m2, d1, q3w*4
Other Names:
  • EC
Drug: Taxanes
Paclitaxel: 80mg/m2, d1, qw*12 or Docetaxel: 80-100mg/m2,d1,q3w*4
Experimental: Taxanes plus carboplatin
Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel + Carboplatin
Drug: Epirubicin plus Cyclophosphamide
Epirubicin 90mg/m2, d1, q3w*4 Cyclophosphamide: 600mg/m2, d1, q3w*4
Other Names:
  • EC
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 3 years
to compare the disease-free survival among two treatment arms
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 3 years
to compare the overall survival among two treatment arms
3 years
Incidence of neutropenia fever
Time Frame: up to 7 months
to compare the neutropenia fever among two treatment arms
up to 7 months
Incidence of grade 3-4 side effects
Time Frame: up to 7 months
to compare the grade 3-4 side effects among two treatment arms
up to 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Kunwei Shen, professor, Affiliated Ruijin Hospital of Shanghai JiaoTong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

May 2, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (Estimate)

May 27, 2015

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJBC1501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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