This randomized phase II trial compared pathologic response rates (pCR) of early breast cancer following neoadjuvant fluorouracil-epirubicin-cyclophosphamide(FEC) and capecitabine-epirubicin-cyclophosphamide (XEC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Breast Cancer Surgery Department of Guangxi Medical University Cancer Center
Nanning, Guangxi, China
pathologic response rates (pCR)
The absence of invasive tumor in the final surgical breast sample (stage yT0 or ypTis)
Time frame: The breast sample will be evaluaed on the day of surgery during the cycle 4, an expected average of 12 weeks.
DFS(Disease free survial)
Time from randmization to breast-cancer recurrence, or a second primay cancer(ecluding contralateral ducal carcinoma in situ), or death from any cause, whichever comes first
Time frame: Participants will be evaluated on Day 1 of each cycle during chemotherapy, and Day 1 every 3 months after completion of chemotherapy. The expected average of 5 years.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Adverse events are classified accoding NCI CTC criteria.
Time frame: Hematologic, renal, and hepatic funcion will be assessed after each cycle and at the end of therapy, an expected average of 3 weeks.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.