Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
The current study is a multicentre, randomized, open (unblended), prospective clinical trial
which is sponsored by the researchers. The trial is designed to compare the effectiveness
between docetaxel plus epirubicin, and docetaxel plus epirubicin plus cyclophosphamide as
neoadjuvant chemotherapy for operable premenopausal breast cancer patients, and also to
compare the outcomes associated with chemo-induced amenorrhea between the two neoadjuvant
chemotherapies. The investigators will randomly assign 600 premenopausal female patients with
operable breast cancer to receive four cycles of docetaxel and epirubicin (TE); or four
cycles of docetaxel, epirubicin, and cyclophosphamide (TEC). After every two cycles of
neoadjuvant chemotherapy, the investigators will estimate the effectiveness of therapy.
Patients will undergo modified radical mastectomy or breast-conserving surgery after four
cycles of neoadjuvant chemotherapy, and then receive postoperative chemotherapy (two cycles),
radiation therapy, herceptin targeted therapy or hormone therapy according to the NCCN (2011)
guideline. The follow-up will be ten years after surgeries. The primary aim is to examine
whether the docetaxel and epirubicin (TE) will be as effective as the docetaxel, epirubicin,
and cyclophosphamide (TEC) (pCR rate, cCR rate, PR rate, SD rate, progression-free survival
(PFS) and overall survival (OS)). The secondary aim is to correlate chemo (TE/TEC)-induced
amenorrhea with outcomes in premenopausal women.
Phase:
N/A
Details
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University