Clinical trial · Interventional
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)
Adjuvant Six Cycles of Docetaxel and Cyclophosphamide or Three Cycles of Cyclophosphamide/Epirubicin/Fluorouracil Followed by Three Cycles of Docetaxel Versus Four Cycles of Epirubicin and Cyclophosphamide Followed by Weekly Paclitaxel in Operable Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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, three cycles of cyclophosphamide/epirubicin/fluorouracil followed by three cycles of docetaxel) to a standard anthracycline/taxane-containing chemotherapy (EC-P, epirubicin and cyclophosphamide for four cycles followed by paclitaxel for twelve weeks) in operable breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- TC*6
- description
- 6 cycles of (Docetaxel 75mg/m2 ivgtt d1+ Cyclophosphamide 600 mg/m2 iv d1, 21 days per cycle) .
- interventionNames
- Drug: Docetaxel
- Drug: Cyclophosphamide
- type
- EXPERIMENTAL
- label
- CEF*3-T*3
- description
- 3 cycles of CEF (Epirubicin 100 mg/m2 ivgtt d1+Cyclophosphamide 500 mg/m2 iv d1+ 5-fluorouracil 500 mg/m2 iv d1, 21 days per cycle) followed by 3 cycles of Docetaxel (Docetaxel 100mg/m2, ivgtt d1, 21 days per cycle)
- interventionNames
- Drug: Docetaxel
- Drug: Cyclophosphamide
- Drug: Epirubicin
- Drug: 5-fluorouracil
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: 1. Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy); 2. Has bilateral breast cancer; 3. Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ. 4. Has metastic (Stage 4) breast cancer; 5. Has any \>T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer); 6. Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives; 7. Patients participating in other clinical trials at the same time; 8. 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; 9. Has known allergy to taxane and excipients; 10. Has severe or uncontrolled infection.
References
Publications (0)
Data not yet available