Phase II study of Letrozole combined with Cyclophosphamide and Capecitabine(LCX) for Hormone-Sensitive advanced breast cancer(age over 65) (JBCRG-14)

Phase 2

• Conditions: Postmenopausal, ER positive and HER2 negative advanced breast cancer

• Registration Number: JPRN-UMIN000006708
• Lead Sponsor: Japan Breast Cancer Research Group (JBCRG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-18
• Study Completion: 2018-09-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

1. Prior chemotherapy or endocrine therapy 2. Need for treatment with taxanes and anthracycline drug 3. need of Treatment with hormone therapy alone 4. Medication that may affect the sex hormone status (hormone replacement therapy, raloxifene, etc.) 5. History or complications of uncontrolled hypertension, severe heart disease (heart failure, ischemic heart disease, endocarditis, valvular heart disease, pericarditis, and congenital heart disease) 6. Active double cancer 7. Inflammatory breast cancer 8. Bilateral breast cancer 9. Medication of investigational new drug 10. Cases in which study participation is considered difficult due to the coexistence of psychosis or psychiatric symptoms 11. Cases considered ineligible by the attending physician for other reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Response Rate: ORR

Secondary Outcome Measures

Name	Time	Method
Pathological Complete Response: pCR Safety Breast Conserving Rate: BCR Disease-free Survival: DFS