Overview

Letrozole Plus Low-Dose Metronomic Capecitabine Versus EC-T (Epirubicin/Cyclophosphamide Followed by Docetaxel) as Neoadjuvant Therapy for ER+/HER2-negative Breast Cancer

Status:
Unknown status

Trial end date:
2020-11-29

Target enrollment:
0

Participant gender:
Female

Summary

Patients with ER+/HER2- breast cancer (presumably the luminal A subtype) could potentially avoid the standard chemotherapy use. Letrozole Plus Low-Dose Metronomic Capecitabine may offer similar efficacy and less toxicity to standard chemotherapy in ER+/HER2- breast cancer patients.

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Guangdong General Hospital
Guangdong Provincial People's Hospital

Treatments:

Capecitabine
Cyclophosphamide
Docetaxel
Epirubicin
Letrozole

Criteria

Inclusion Criteria:

-women (age 18-70 years) with clinical T2-3 N0-1 M0 ER-positive (ER) allred score 4-8，and
progesterone receptor-positive (PgR) ，HER2-negative adequate bone marrow reserve (WBC
count, 3.5 *109/L; platelets, 100*109/L; hemoglobin, 10g/dL), hepatic function (AST/ALT
bilirubin and alkaline phosphatase levels 1.25 the upper limit of normal value), and renal
function (serum creatinine 1.25 the upper limit of normal value).

Luminal A/ lymph node positive breast cancer or Luminal B breast cancer patients

Exclusion Criteria:

- (a) male patients; (b) patients with inflammatory breast cancer or distant metastasis;
(c) patients who were previously treated with chemotherapy, radiation therapy or prior
treatment with AIs or antiestrogens for breast cancer; (d) patients with a second
concomitant neoplasm; and (e) patients who could not meet the eligibility criteria.