A Trial of Neoadjuvant Everolimus Plus Letrozole Versus FEC in Women With ER-positive, HER2-negative Breast Cancer
Status:
Completed
Trial end date:
2020-03-14
Target enrollment:
Participant gender:
Summary
This open, randomized pilot feasibility trial is to evaluate the feasibility and effect of
neoadjuvant everolimus plus letrozole versus neoadjuvant fluorouracil, epirubicin plus
cyclophosphamide (FEC) in treating postmenopausal women with ER-positive, HER2-negative
breast cancer. Forty postmenopausal stage M0, ER-positive, HER2-negative invasive breast
cancer women who had a primary tumor > 2cm by imaging or an axillary lymph node > 2cm by
imaging were randomly (1:1) enrolled to receive neoadjuvant everolimus plus letrozole for 18
weeks or neoadjuvant FEC for 6 cycles before surgery. The primary objective is to determine
the feasibility of neoadjuvant everolimus plus letrozole in postmenopausal patients with
ER-positive, HER2-negative breast cancer. Secondary aims are to compare the ultrasound
response rate, pathological complete response (pCR) rate, breast-conserving surgery rate,
toxicities, and changes in the percentages or counts of peripheral blood CD4+ T cells, CD8+ T
cells, tumor-specific CTLs, T helper cells (Th), regulatory T cells (Treg), and NK cells and
changes in tumor Ki67 index (pre- versus post- neoadjuvant therapy).
Phase:
Phase 2
Details
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University