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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Neoplasm

Intervention / Treatment
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* Drug: Epirubicin plus Cyclophosphamide
* Drug: Taxanes
* Drug: Taxanes plus Carboplatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carboplatin, chemptherapy, triple negative, taxanes