Assessment of the Efficacy of High-Dose Toremifene 120mg Therapy for Anastorozole-resistant Postmenopausal Breast Cancer (SBCCSG-11)

Phase 2

• Conditions: Postmenopausal breast cancer

• Registration Number: JPRN-UMIN000000967
• Lead Sponsor: Saitama Breast Cancer Clinical Study Group (SBCCSG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-07
• Study Completion: 2013-01-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients under anti-estrogen hormone therapy 2. Patients under hormone therapy except for anastrozole 3. Patients diagnosed as inflammatory breast cancer 4. Patients with a history of deep venous thrombosis 5. Patients with serious complications A. Patients with ischemic heart disease or cardiac arrhythmia that need treatment(left ventricular hypertrophy or mild left ventricular load induced by hypertension,or mild right bundle-branch block is eligible) B. Patients with a history of myocardial infarction within 6 months onset C. Patietns with uncontrollable diabetes 6. Patients with brain metastasis 7. Patients taking raloxifen (belonging to SERM) for treatment of osteoporosis 8. Doctor's decision for exclusion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
clinical benefit

Secondary Outcome Measures

Name	Time	Method
1. clinical responce rate 2. progression free survival(PFS) 3. time to progression(TTP) 4. adverse events