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)

NCT ID: NCT04127019

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2079 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-01
• Study Completion Date: 2017-06-15

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.

Conditions

Primary Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TC*6

6 cycles of (Docetaxel 75mg/m2 ivgtt d1+ Cyclophosphamide 600 mg/m2 iv d1, 21 days per cycle) .

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Docetaxel chemotherapy (injection)

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide chemotherapy (injection)

CEF*3-T*3

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)

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Docetaxel chemotherapy (injection)

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide chemotherapy (injection)

Epirubicin

Intervention Type: DRUG

Epirubicin chemotherapy (injection)

5-fluorouracil

Intervention Type: DRUG

5-fluorouracil chemotherapy (injection)

EC*4-wP*12

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).

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

Paclitaxel chemotherapy (injection)

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide chemotherapy (injection)

Epirubicin

Intervention Type: DRUG

Epirubicin chemotherapy (injection)

Interventions

Paclitaxel

Paclitaxel chemotherapy (injection)

Intervention Type: DRUG

Docetaxel

Docetaxel chemotherapy (injection)

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide chemotherapy (injection)

Intervention Type: DRUG

Epirubicin

Epirubicin chemotherapy (injection)

Intervention Type: DRUG

5-fluorouracil

5-fluorouracil chemotherapy (injection)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhimin Shao

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhi-Ming Shao

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Other Identifiers

MASTER

Identifier Type: -

Identifier Source: org_study_id