Overview

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

Status:
Completed
Trial end date:
2017-06-15
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fudan University
Collaborator:
Chinese Anti-Cancer Association
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)

- 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.