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)

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2017

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

  • Drug: Paclitaxel
    • Paclitaxel chemotherapy (injection)
  • Drug: Docetaxel
    • Docetaxel chemotherapy (injection)
  • Drug: Cyclophosphamide
    • Cyclophosphamide chemotherapy (injection)
  • Drug: Epirubicin
    • Epirubicin chemotherapy (injection)
  • Drug: 5-fluorouracil
    • 5-fluorouracil chemotherapy (injection)

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • disease-free survival
    • Time Frame: 5 year

Secondary Measures

  • distant disease-free survival
    • Time Frame: 5 year
  • overall survival
    • Time Frame: 5 year

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fudan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhimin Shao, professor – Fudan University
  • Overall Official(s)
    • Zhi-Ming Shao, Principal Investigator, Fudan University

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