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

NCT ID: NCT01314833

Last Updated: 2020-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1570 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 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.

Detailed Description

It was initiated as an adjuvant chemotherapy trial 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]) in HER2-negative breast cancer. Patients were randomly assigned (1:1:1) to each arm after completing the surgical excision of the primary tumor.

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 Cyclophosphamide

Intervention Type: DRUG

Docetaxel 75 mg/m² D1 Cyclophosphamide 600 mg/m² D1

1 cycle = 21 days

TC*6

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

Cyclophosphamide Fluorouracil Epirubicin Docetaxel

Intervention Type: 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

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

Epirubicin Cyclophosphamide Paclitaxel

Intervention Type: 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

Interventions

Docetaxel Cyclophosphamide

Docetaxel 75 mg/m² D1 Cyclophosphamide 600 mg/m² D1

1 cycle = 21 days

TC*6

Intervention Type: DRUG

Cyclophosphamide Fluorouracil Epirubicin Docetaxel

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

Intervention Type: DRUG

Epirubicin Cyclophosphamide Paclitaxel

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

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)
• 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
• 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 the previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.

4. Has metastatic (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 breastfeeding 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

Chinese Anti-Cancer Association

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhimin Shao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 19204201 (View on PubMed)

Other Identifiers

MASTER

Identifier Type: -

Identifier Source: org_study_id