Clinical Trials Logo
  1. Home
  2. Breast Cancer
  3. NCT03045653

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

Breast Cancer Metastatic Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03045653
Study type Interventional
Source Sun Yat-sen University
Contact
Status Completed
Phase Phase 2
Start date September 1, 2017
Completion date February 21, 2019
View Details
See also
  Status Clinical Trial Phase
Terminated NCT04123704 - Sitravatinib in Metastatic Breast Cancer Phase 2
Active, not recruiting NCT04509596 - DZD1516 in Combination With Trastuzumab and Capecitabine, or in Combination With T-DM1, in Patients With Metastatic HER2 Positive Breast Cancer Phase 1
Recruiting NCT04122469 - The Role of Stereo-tActic BoDy RadIotherApy iN Oligo-Progressive MalignanT Disease N/A
Terminated NCT03322215 - HR+/HER2- Advanced Breast Cancer and Endocrine Resistance Phase 2
Active, not recruiting NCT04059484 - Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer Phase 2
Recruiting NCT04368442 - Cohort Study of Patients With HER2-negative MBC and BRCA 1/2 Pathogenic Mutation
Terminated NCT03709082 - Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer Phase 1/Phase 2
Terminated NCT03642990 - NR in Chemo-induced Peripheral Neuropathy Phase 2
Terminated NCT01876251 - A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer Phase 1
Completed NCT04483505 - Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer. Phase 1
Recruiting NCT03086785 - Prospective, Multicenter, Observational Study of Apatinib Single or Combined Capecitabine for Treatment of Patients With Metastatic Her-2 Negative Breast Cancer Phase 2
Terminated NCT04197999 - A Study to Determine Safety and Tolerability of GMI-1359 in Subjects With HR+ Metastatic Breast Cancer Phase 1
Not yet recruiting NCT06439693 - The SAPPHO Study: A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer Phase 2
Not yet recruiting NCT03638765 - Dendritic Cell Therapy for Brain Metastases From Breast- or Lung Cancer Phase 1
Recruiting NCT06100874 - A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN) Phase 2
Completed NCT05609903 - Atezolizumab With Nab-paclitaxel for Patients With Triple-negative Stage IV Breast Cancer
Active, not recruiting NCT04597580 - Personalised Disease Monitoring in Metastatic Breast Cancer
Completed NCT05301530 - Clinical Trial to Assess Pharmacokinetic Parameters and Safety of NNG-TMAB (Trastuzumab) on Recurrent or Metastatic Breast Cancer Patients. Phase 1
Active, not recruiting NCT03328884 - Evaluation of the Efficacy and Safety of Nal-IRI for Progressing Brain Metastases in Breast Cancer Patients Phase 2
Recruiting NCT05837533 - Multicenter Study to Evaluate a Systematized Communication Model for Breast Cancer Patients N/A