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.
Unknown status
Phase 2/Phase 3
| Drug | Synonyms | Arms |
|---|---|---|
| Letrozole Plus Low-Dose Metronomic Capecitabine | Letrozole Plus Low-Dose Metronomic Capecitabine | |
| EC-T | EC-T |
| Name | Type | Description | Interventions |
|---|---|---|---|
| Letrozole Plus Low-Dose Metronomic Capecitabine | Experimental |
| |
| EC-T | Active Comparator |
|
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.
| Maximum Eligible Age: | 70 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
| Measure: | objective response rate |
| Time Frame: | 6 month |
| Safety Issue: | |
| Description: | objective response rate (ORR) measured by breast ultrasound monthly |
| Phase: | Phase 2/Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Unknown status |
| Lead Sponsor: | Guangdong Provincial People's Hospital |
April 25, 2018
