Breast Neoplasm
Conditions
Keywords
chemptherapy, triple negative, taxanes, carboplatin
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.
Interventions
DRUGEpirubicin plus Cyclophosphamide
Epirubicin 90mg/m2, d1, q3w\*4 Cyclophosphamide: 600mg/m2, d1, q3w\*4
DRUGTaxanes
Paclitaxel: 80mg/m2, d1, qw\*12 or Docetaxel: 80-100mg/m2,d1,q3w\*4
DRUGTaxanes 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
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | From time of randomization to 5 years after enrollment. | The time from randomization to local or regional recurrence, distant metastases, other non-breast secondary primary malignancies, contralateral breast cancer, or death due to any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distant disease-free survival | From time of randomization to 5 years after enrollment. | The time from randomization to distant metastases, other non-breast secondary primary malignancies, or death due to any cause, whichever occurs first. |
| Overall Survival | From time of randomization to 5 years after enrollment. | The time from randomization to death due to any cause. |
| Incidence of adverse events | From randomization to four weeks after end of study treatment | To compare the grade 3-5 adverse events among two treatment arms according to the NCI-CTCAE v4.0 criteria. |
Countries
China
Outcome results
None listed