Description:
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.
Title
- Brief Title: Adjuvant Treatment of EC Followed by Taxane +/- Carboplatin in Triple-Negative Breast Cancer
- Official Title: Epirubicin-Cyclophosphamide Followed by Taxanes or Taxanes Plus Carboplatin in Triple-Negative Breast Cancer:A Prospective, Randomized, Phase III Trial
Clinical Trial IDs
- ORG STUDY ID:
RJBC1501
- NCT ID:
NCT02455141
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Epirubicin plus Cyclophosphamide | EC | Taxanes |
Taxanes | | Taxanes |
Taxanes plus Carboplatin | | Taxanes plus carboplatin |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Taxanes | Active Comparator | Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel | - Epirubicin plus Cyclophosphamide
- Taxanes
|
Taxanes plus carboplatin | Experimental | Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel + Carboplatin | - Epirubicin plus Cyclophosphamide
- Taxanes plus Carboplatin
|
Eligibility Criteria
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.
Maximum Eligible Age: | 70 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Disease-free survival |
Time Frame: | 3 years |
Safety Issue: | |
Description: | to compare the disease-free survival among two treatment arms |
Secondary Outcome Measures
Measure: | Overall Survival |
Time Frame: | 3 years |
Safety Issue: | |
Description: | to compare the overall survival among two treatment arms |
Measure: | Incidence of neutropenia fever |
Time Frame: | up to 7 months |
Safety Issue: | |
Description: | to compare the neutropenia fever among two treatment arms |
Measure: | Incidence of grade 3-4 side effects |
Time Frame: | up to 7 months |
Safety Issue: | |
Description: | to compare the grade 3-4 side effects among two treatment arms |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Shanghai Jiao Tong University School of Medicine |
Trial Keywords
- chemptherapy
- triple negative
- taxanes
- carboplatin
Last Updated
April 14, 2020