Efficacy of High Dose Tamoxifen to Advanced Hormone Receptor-High Expressed Breast Cancer
Status:
Completed
Trial end date:
2019-02-21
Target enrollment:
Participant gender:
Summary
Background: Endocrine therapy is an effective and safe treatment for hormone receptor
positive breast cancer. Unfortunately , endocrine treatment resistance occurs and there is an
urgent need for treatment alternative. Laboratory researches and clinical case reports
indicate that hormone receptor-high expressed breast cancer patients may potentially benefit
from high-dose Tamoxifen or high-dose Tamoxifen plus chemotherapy , providing a new option
for treatment strategy.
Aim: To explore the efficacy and safety of high-dose Tamoxifen to standard hormone
receptor-high expressed endocrine therapy resisted breast cancer.
Methods: Eligible patients will be treated with tamoxifen 100 mg/d or high-dose Tamoxifen(100
mg/d ) plus chemotherapy. Blood and tumor samples will be obtained from the patients.Evaluate
curative effect every 3 months.
Primary endpoint: progression-free survival (PFS). Secondary endpoints: objective response
rate (ORR), clinical benefit rate (CBR), overall survival (OS) and safety.
Exploratory endpointsincluded the efficacy predictive value of the 18F-FES SUVmax.