Status:
COMPLETED
Adjuvant 6 Cycles of Docetaxel and Cyclophosphamide or 3 Cycles of Cyclophosphamide/Epirubicin/Fluorouracil Followed by 3 Cycles of Docetaxel Versus 4 Cycles of Epirubicin and Cyclophosphamide Followed by Weekly Paclitaxel in Operable Breast Cancer (MASTER)
Lead Sponsor:
Fudan University
Conditions:
Primary Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief Summary
We aimed to evaluate the noninferiority of a short-term anthracycline-free chemotherapy (TC, six cycles of docetaxel and cyclophosphamide) or a short-term anthracycline-based chemotherapy (CEF-T, thre...
Detailed Description
It was initiated as an adjuvant chemotherapy trial in 2010 to test noninferiority of an anthracycline-free short-term regimen (T75C600 x 6 \[TC\] once every 3 weeks) or a short-term regimen (C500E100F...
Eligibility Criteria
Inclusion
- Female patients, age at diagnosis 18 - 75 years
- Histological confirmed unilateral primary invasive carcinoma of the breast
- Adequate surgical treatment with complete resection of the tumor (R0) and resection of \> or = 10 axillary nodes or SLN in clinically N0 patients
- Node positive disease or node negative disease with at least one other risk factor (tumor size \> or = 2 cm, grade \> or = II)
- No evidence for distant metastasis (M0) after conventional staging
- Performance Status ECOG \< or = 1
- The patient must be accessible for treatment and follow-up
- LVEF\> 50%
- Negative pregnancy test (urine or serum) within 7 days prior to randomization in premenopausal patients
- Leucocytes \> or = 4 x 10\^9/L
- platelets \> or = 100 x 10\^9/L
- haemoglobin \> or = 9 g/dL
- total bilirubin \< or = 1.5 UNL
- ASAT (SGOT) and ALAT (SGPT) \< or = 2.5 UNL
- creatinine \< 175 mmol/L (2 mg/dL)
Exclusion
- Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy）;
- Has bilateral breast cancer;
- Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
- Has metastic (Stage 4) breast cancer;
- Has any \>T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer);
- Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives;
- Patients participating in other clinical trials at the same time;
- Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) \< 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure\>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;
- Has known allergy to taxane and excipients;
- Has severe or uncontrolled infection.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2017
Estimated Enrollment :
2079 Patients enrolled
Trial Details
Trial ID
NCT04127019
Start Date
June 1 2010
End Date
June 15 2017
Last Update
February 26 2020
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