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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04127019

Enrollment

2079

Registered

2019-10-15

Start date

2010-06-01

Completion date

2017-06-15

Last updated

2020-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Breast Cancer

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, 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.

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 (C500E100F500 x 3 once every 3 weeks followed by T100 x 3 every 3 weeks \[CEF-T\]) compared with a standard long-term anthracycline-containing regimen (E90C600 x 4 once every 3 weeks followed by P80 x 12 once every week \[EC-P\]). Patients were randomly assigned (1:1:1) to each arm after completing surgical excision of primary tumor. Trastuzumab was administered in combination with chemotherapy to patients with HER2-positive breast cancer and sustained monotherapy as per the current guidelines.

Interventions

DRUGPaclitaxel

Paclitaxel chemotherapy (injection)

DRUGDocetaxel

Docetaxel chemotherapy (injection)

DRUGCyclophosphamide

Cyclophosphamide chemotherapy (injection)

DRUGEpirubicin

Epirubicin chemotherapy (injection)

DRUG5-fluorouracil

5-fluorouracil chemotherapy (injection)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Experimental: Arm 1 6 cycles of (Docetaxel 75mg/m2 ivgtt d1+ Cyclophosphamide 600 mg/m2 iv d1, 21 days per cycle) . Experimental: Arm 2 3 cycles of FEC (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) Experimental: Arm 3 4 cycles of EC (Epirubicin 90 mg/m2 ivgtt d1+Cyclophosphamide 600 mg/m2 iv d1+ , 21 days per cycle) followed by 4 cycles of Paclitaxel (Paclitaxel 80mg/m2, ivgtt d1,8,15, 21days per cycle).

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
disease-free survival	5 year

Secondary

Measure	Time frame
distant disease-free survival	5 year
overall survival	5 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026