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

• Status: Completed
• Trial end date: 2017-06-15
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Docetaxel; Epirubicin; Fluorouracil; Paclitaxel

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)

• 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.