NCT03045653

Efficacy of High Dose Tamoxifen to Advanced Hormone Receptor-High Expressed Breast Cancer

Efficacy and Safety of High Dose Tamoxifen to Advanced Hormone Receptor-High Expressed Endocrine Therapy Resisted Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Tamoxifen Oral Product	Tamoxifen 100 mg/d or high-dose Tamoxifen(100 mg/d ) plus chemotherapy

Timeline

• Start date: 2017-09-01
• Primary completion: 2019-02-21
• Completion: 2019-02-21
• First posted: 2017-02-07
• Last updated: 2022-03-28
• Results posted: 2019-10-02

Locations

1 site across 1 country: China