Breast Cancer
Conditions
Keywords
letrozole, metronomic, capecitabine, neoadjuvant, chemotherapy, ER+/HER2-
Brief 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.
Interventions
DRUGLetrozole Plus Low-Dose Metronomic Capecitabine
Letrozole Plus Low-Dose Metronomic Capecitabine
DRUGEC-T
Epirubicin/Cyclophosphamide Followed by Docetaxel
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | 6 month | objective response rate (ORR) measured by breast ultrasound monthly |
Countries
China
Outcome results
None listed