Untreated women with triple negative breast cancer (T1c-4NxM0)
Conditions
Interventions
challenging arm received three cycles of docetaxel plus capecitabine (TX) followed by three cycles of cyclophosphamide, epirubicin, and capecitabine (CEX). TX comprised capecitabine 900mg/m2 given ora
75 mg/m2 as a 1-hour intravenous infusion on day 1 of every 4-week cycle) followed by four cycles of cyclophosphamide (500 mg/m2), epirubicin (100 mg/m2), and fluorouracil (500 mg/m2
CEF), all administered on day 1 of each 4-week cycle.
Sponsors
Japanese Red Cross Society Himeji Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Disease-Specific Inclusion Criteria 1. Histologically or cytologically confirmed invasive carcinoma of the breast, and candidate for chemotherapy. 2. Tumor is radically resectable (T1c-T3, Nx, M0), and its maximum axis is no more than 7cm. If patient has multiple lesions, all of them must meet this criteria, and be confirmed malignancy by pathological examination). There is at least one primary lesion, whose size could be assessed and measured by contrast-enhanced MRI at both time pre- and post-chemotherapy. 3. ER-negative and HER2-negative (FISH-negative or IHC 0-1+) were confirmed by each center's laboratory. General Inclusion Criteria 4. Age >= 20 years, <65. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. 6. Left Ventricular Ejection Fraction (LVEF) >= 50% at baseline (within 28 days of randomization) as determined by ECHO. 7. For women of childbearing potential, agreement to use an effective form of contraception (patient and/or partner, e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) and to continue its use for the duration of study treatment and for 6 months after the last dose of study treatment. 8. Signed, written informed consent (approved by the Institutional Review Board or Independent Ethics Committee) obtained prior to any study procedure.
Exclusion criteria
Exclusion criteria: Cancer-Related Exclusion Criteria 1. History of anticancer therapy for breast cancer. This includes any EGFR or anti-HER2 agents or vaccines, cytotoxic chemotherapy, or more than one prior hormonal regimen for breast cancer. 2. History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix, basal cell carcinoma, thyroid cancer, early stage stomach, or colon cancer. 3. Current uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg) or unstable angina 4. History of CHF of any New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment (exception, atrial fibrillation, paroxysmal supraventricular tachycardia). History of myocardial infarction within 6 months of randomization. 5. Current dyspnea at rest due to complications of interstitial pneumonia, or other diseases that require continuous oxygen therapy General Exclusion Criteria 6. Inadequate organ function, evidenced by the following laboratory results within 28 days prior to randomization: Absolute neutrophil count < 1,500 cells/mm3 Platelet count < 100,000 cells/mm3 Hemoglobin < 9 g/dL Total bilirubin > upper limit of normal (ULN) AST (SGOT) and ALT (SGPT) > 2.5 x ULN Serum creatinine > 2.0 mg/dL 7. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures) 8. Pregnant or lactating women 9. History of receiving any investigational treatment within 28 days of randomization 10. Receipt of intra-venous antibiotics for infection within 14 days of randomization 11. Current chronic daily treatment with corticosteroids (dose of > 10 mg per day methylprednisolone equivalent) 12. Known hypersensitivity to any of the study drugs 13. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of pathological complete response | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0, and chemotherapy doses were modified based on toxicity observed. Overall response rate: was objective response rate according to RECIST version 1.1. Disease free survival; which was defined as the time interval between random assignment and date of diagnosis of invasive breast cancer recurrence (local or distant) or death if the patient died before recurrence. Contralateral breast cancers and second cancers were not counted as DFS events. Overall survival; which was defined as the time from random assignment to death. | — |
Countries
Japan
Contacts
Public ContactYukari Fujikado
Japanese Red Cross Society Himeji Hospital Clinical Trial Manegement Office
Outcome results
None listed