minus anthracycline or short-term versus epirubicin and cyclophosphamide followed by paclitaxel regimen for adjuvant breast cancer therapy

Conditions: Primary Breast Cancer

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.

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.

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) \ 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.

Keywords: luminal a luminal b tnbc dfs ddfs os