Primary Breast Cancer
Conditions
Keywords
Luminal A, Luminal B, TNBC, DFS, DDFS, OS
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.
Interventions
DRUGDocetaxel Cyclophosphamide
Docetaxel 75 mg/m² D1 Cyclophosphamide 600 mg/m² D1 1 cycle = 21 days TC\*6
DRUGCyclophosphamide 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
DRUGEpirubicin 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
Sponsors
Chinese Anti-Cancer Association
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival | 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distant Disease-Free Survival | 5 years | Defined as the time from randomization to the earliest recurrence outside of the ipsilateral locoregional region or to death from any cause, whenever a death occurred before distant recurrence |
| Overall Survival | 5 years | defined as the time from randomization to death from any cause |
| Adverse Events | through chemotherapy completion, an average of 6 months | Number of Participants with Adverse Events |
Countries
China
Outcome results
None listed