Efficacy of High Dose Tamoxifen to Advanced Hormone Receptor-High Expressed Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03045653|
Recruitment Status : Completed
First Posted : February 7, 2017
Results First Posted : October 2, 2019
Last Update Posted : November 4, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Metastatic||Drug: Tamoxifen Oral Product||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of High Dose Tamoxifen to Advanced Hormone Receptor-High Expressed Endocrine Therapy Resisted Breast Cancer|
|Actual Study Start Date :||September 1, 2017|
|Actual Primary Completion Date :||February 21, 2019|
|Actual Study Completion Date :||February 21, 2019|
Experimental: treatment arm
receiving a treatment of tamoxifen 100 mg/d or high-dose Tamoxifen(100 mg/d ) plus chemotherapy
Drug: Tamoxifen Oral Product
Tamoxifen 100 mg/d or high-dose Tamoxifen(100 mg/d ) plus chemotherapy
- Progression-free Survival (PFS) [ Time Frame: 36months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045653
|Sun Yat-sen University, Cancer Center|
|Guangzhou, Guangdong, China, 510060|
|Principal Investigator:||Zhongyu Yuan||Sun-yatsen University Cancer center|