Locally Advanced Breast Cancer
Conditions
Brief summary
This is a multicenter, open-label, phase IV trial to assess the efficacy and safety of sequential neoadjuvant chemotherapy with 4 cycles of doxorubicin/cyclophosphamide followed by 4 cycles of docetaxel(Monotaxel®) in patients with breast cancer of ≥5cm in size or cytologically confirmed axillary lymph nodes metastasis.
Interventions
DRUGNeoadjuvant Chemotherapy with Docetaxel
Doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 (day 1), IV (in the vein), every 21 days, a total of 4 cycles -\> Docetaxel 100 mg/m2 (day 1) IV, every 21 days, a total of 4 cycles
Sponsors
Yonsei University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with histologically proven invasive breast cancer - the primary tumor size is at least 5cm or cytologically proven axillary node metastasis 2. no evidence of systemic metastasis pathologically or radiologically 3. age at the time of diagnosis between 20 and 70 years 4. patients with previously untreated primary breast cancer including chemotherapy 5. general performance status with ECOG 0-2 6. sufficient hematopoietic function (absolute neutrophil count of ≥ 1,500/mm3, platelet count of ≥ 100,000/mm3, and hemoglobin of ≥ 10 g/dL) 7. sufficient renal function (serum creatinine level of ≤ 1.5 mg/dL) 8. sufficient liver function (total serum bilirubin level ≤ 1.5 times the upper normal limit; serum AST and ALT levels ≤ 1.5 times the upper normal limit; and serum alkaline phosphatase level ≤ 1.5 times the upper normal limit) 9. sufficient cardiac function (normal electrocardiography within 1 month or LVEF\>50% by echocardiography or MUGA scan within 3 months) 10. patients who agree to enroll this clinical trial and sign the written informed consent voluntarily
Exclusion criteria
1. patients with evidence of distant metastases 2. patients with other previous malignancy except breast cancer 3. pregnant (positive hCG test 1 week before registration) or lactating patient 4. uncontrolled serious infection 5. patients with psychiatric disease or epilepsy 6. patients with clinically severe cardiac disease within 6 months such as atrial or ventricular arrhythmia, congestive heart failure, myocardial infarction, or unstable angina 7. male breast cancer 8. patients with poor general condition who are not able to understand or sign the written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Complete Response | 26 weeks after the first administration of neoadjuvant chemotherapy with doxorubicin/cyclophosphamide regimens | Pathologic complete response is defined as the disappearance of all invasive cancer in the postsurgical breast and lymph node specimens after completion of neoadjuvant chemotherapy. Only residual intraductal carcinoma in the postsurgical breast specimen after neoadjuvant chemotherapy is also considered as the achievement of pathologic complete response. |
Countries
South Korea
Outcome results
None listed