Adjuvant Treatment of EC Followed by Taxane +/- Carboplatin in Triple-Negative Breast Cancer
- Conditions
- Breast Neoplasm
- Interventions
- Registration Number
- NCT02455141
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 970
Not provided
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Taxanes Epirubicin plus Cyclophosphamide Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel Taxanes plus carboplatin Epirubicin plus Cyclophosphamide Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel + Carboplatin Taxanes Taxanes Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel Taxanes plus carboplatin Taxanes plus Carboplatin Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel + Carboplatin
- Primary Outcome Measures
Name Time Method Disease-free survival 3 years to compare the disease-free survival among two treatment arms
- Secondary Outcome Measures
Name Time Method Incidence of neutropenia fever up to 7 months to compare the neutropenia fever among two treatment arms
Overall Survival 3 years to compare the overall survival among two treatment arms
Incidence of grade 3-4 side effects up to 7 months to compare the grade 3-4 side effects among two treatment arms
Trial Locations
- Locations (27)
Fuding Hospital
🇨🇳Fuding, Fujian, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Quanzhou First Hospital
🇨🇳Quanzhou, Fujian, China
Foshan No.1 People's Hospital
🇨🇳Foshan, Guangdong, China
Guangdong Maternal and Child Health Care Hospital
🇨🇳Guangzhou, Guangdong, China
Cancer Hospital Affiliated to Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Jiangsu Jiangyin People's Hospital
🇨🇳Jiangyin, Jiangsu, China
The First People's Hospital of Wujiang District
🇨🇳Suzhou, Jiangsu, China
Yancheng Hospital of TCM
🇨🇳Yancheng, Jiangsu, China
Obstetrics & Gynecology Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
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