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)

NCT04127019 | Completed Phase 3 DMC

• 1 other identifier: MASTER
• Study Type: interventional
• Target: 2,079
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Breast Cancer

Outcome Measures

Primary Outcomes (1)

• disease-free survival

  5 year

Secondary Outcomes (2)

• distant disease-free survival

  5 year

• overall survival

  5 year

Study Arms (3)

TC*6

EXPERIMENTAL

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

Drug: Docetaxel; Drug: Cyclophosphamide

CEF*3-T*3

EXPERIMENTAL

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)

Drug: Docetaxel; Drug: Cyclophosphamide; Drug: Epirubicin; Drug: 5-fluorouracil

EC*4-wP*12

EXPERIMENTAL

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).

Drug: Paclitaxel; Drug: Cyclophosphamide; Drug: Epirubicin

Interventions

Paclitaxel DRUG

Paclitaxel chemotherapy (injection)

EC*4-wP*12

Docetaxel DRUG

Docetaxel chemotherapy (injection)

CEF*3-T*3; TC*6

Cyclophosphamide DRUG

Cyclophosphamide chemotherapy (injection)

CEF*3-T*3; EC*4-wP*12; TC*6

Epirubicin DRUG

Epirubicin chemotherapy (injection)

CEF*3-T*3; EC*4-wP*12

5-fluorouracil DRUG

5-fluorouracil chemotherapy (injection)

CEF*3-T*3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Interventions

Paclitaxel; Docetaxel; Cyclophosphamide; Epirubicin; Fluorouracil

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Zhi-Ming Shao

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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).

Study Record Dates

• First Submitted: October 12, 2019
• First Posted: October 15, 2019
• Study Start: June 1, 2010
• Primary Completion: June 1, 2017
• Study Completion: June 15, 2017
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share