Minus Anthracycline or Short-Term Versus Epirubicin and Cyclophosphamide Followed by Paclitaxel Regimen for Adjuvant Breast Cancer Therapy

NCT01314833 | Completed Phase 3 DMC

• 1 other identifier: MASTER
• Study Type: interventional
• Target: 1,570
• Locations: 1 country
• Sites: 1

Brief Summary

We aimed to evaluate the noninferiority of short-term anthracycline-free chemotherapy (TC, six cycles of docetaxel and cyclophosphamide) or 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 HER2-negative operable breast cancer.

Conditions

Primary Breast Cancer

Keywords

Luminal A; Luminal B; TNBC; DFS; DDFS; OS

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival

  Defined as the time from randomization to occurrence of a new event including local recurrence, regional relapse, distant metastasis, contralateral primary breast cancer, second non-breast invasive cancer (excluding non-melanoma skin cancers), or death from any cause.

  5 years

Secondary Outcomes (3)

• Distant Disease-Free Survival

  5 years

• Overall Survival

  5 years

• Adverse Events

  through chemotherapy completion, an average of 6 months

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 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: Cyclophosphamide Fluorouracil Epirubicin Docetaxel

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: Epirubicin Cyclophosphamide Paclitaxel

Interventions

Docetaxel Cyclophosphamide DRUG

Docetaxel 75 mg/m² D1 Cyclophosphamide 600 mg/m² D1 1 cycle = 21 days TC\*6

TC*6

Cyclophosphamide Fluorouracil Epirubicin Docetaxel DRUG

1st -3rd Cycle: Fluorouracil 500 mg/m² D1 Epirubicin 100 mg/m² D1 Cyclophosphamide 500 mg/m² D1 1 cycle = 21 days 4th-6th Cycle: Docetaxel 100mg/m² D1 1 cycle = 21 days CEF\*3-T\*3

CEF*3-T*3

Epirubicin Cyclophosphamide Paclitaxel DRUG

1st-4th Cycle: Epirubicin 90 mg/m² D1 Cyclophosphamide 600 mg/m² D1 1 cycle = 21 days 5th-8th Cycle: Paclitaxel 80mg/m² D1, 8, 15 1 cycle = 21 days EC\*4-P\*4

EC*4-wP*12

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)
• HER2-negative disease
• 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

You may not qualify if:

• Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy）;
• Has bilateral breast cancer;
• Has the previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
• Has metastatic (Stage 4) breast cancer;
• Has any \>T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer);
• Is pregnant, is breastfeeding 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
• Chinese Anti-Cancer Association: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

• Jones S, Holmes FA, O'Shaughnessy J, Blum JL, Vukelja SJ, McIntyre KJ, Pippen JE, Bordelon JH, Kirby RL, Sandbach J, Hyman WJ, Richards DA, Mennel RG, Boehm KA, Meyer WG, Asmar L, Mackey D, Riedel S, Muss H, Savin MA. Docetaxel With Cyclophosphamide Is Associated With an Overall Survival Benefit Compared With Doxorubicin and Cyclophosphamide: 7-Year Follow-Up of US Oncology Research Trial 9735. J Clin Oncol. 2009 Mar 10;27(8):1177-83. doi: 10.1200/JCO.2008.18.4028. Epub 2009 Feb 9.

  PMID: 19204201 BACKGROUND

MeSH Terms

Interventions

CP protocol

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

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: March 15, 2011
• Study Start: June 1, 2010
• Primary Completion: June 1, 2017
• Study Completion: June 15, 2017
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)