Phase II randomized clinical trial evaluating neoadjuvant chemotherapy regimens with tri-weekly docetaxel (D) followed by doxorubicin, 5-fluorouracil, and cyclophosphamide (FEC) or docetaxel with concurrent use of capecitabine (TX) followed by doxorubicin, cyclophosphamide, and capecitabine (CEX) in women with locally advanced triple-negative breast cancer
- Conditions
- ntreated women with triple negative breast cancer (T1c-4NxM0)
- Registration Number
- JPRN-UMIN000018722
- Lead Sponsor
- Japanese Red Cross Society Himeji Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 84
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of pathological complete response
- Secondary Outcome Measures
Name Time Method 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.