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)

Last updated: February 23, 2020
Sponsor: Fudan University
Overall Status: Completed

Phase

3

Condition

Breast Cancer

Treatment

N/A

Clinical Study ID

NCT04127019
MASTER
  • Ages 18-75
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 inpremenopausal 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

Exclusion Criteria:

  1. Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapyor endocrine therapy）;

  2. Has bilateral breast cancer;

  3. Has previous history of additional malignancy, with the exception of adequatelytreated 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, andinflammatory breast cancer);

  6. Is pregnant, is breast feeding women, or women of childbearing age who cannot practiceeffective contraceptives;

  7. Patients participating in other clinical trials at the same time;

  8. Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, leftventricular ejection fraction (LVEF) < 50% (cardiac ultrasound); severe cardiocerebral vascular disease within the 6 months previous of randomization (such asunstable angina, chronic heart failure, uncontrolled hypertension with bloodpressure>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabeticpatients with poor blood glucose control; patients with severe hypertension;

  9. Has known allergy to taxane and excipients;

  10. Has severe or uncontrolled infection.

Study Design

Total Participants: 2079
Study Start date:
June 01, 2010
Estimated Completion Date:
June 15, 2017

Study 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.