Predictive Value of Genetic Analysis for Pathological Complete Response to Preoperative Treatment in HER2-Positive HR-Negative Early Breast Cancer

Not Applicable

• Conditions: HER2-positive HR-negative breast cancer

• Registration Number: JPRN-UMIN000028065
• Lead Sponsor: Japan Agency for Medical Research and development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-01
• Last Update Posted: 17 October 2023
• Study Completion: 2025-10-29

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

1. Active other malignancies
2. Bilateral breast cance
3. Multicentric tumors
4. History of congestive heart failure or myocardial infarction, arrhythmia or heart valvular disease requiring treatment
5. Clinically significant infection
6. Pregnant or breast-feeding women, women of childbearing potential
7. Diabetes uncontrolled or requiring insulin
8. Systemic sclerosis or systemic lupus erythematosus
9. Systemic use of steroids or immunosuppressive agents
10. Unsuitable mental status for participation
11. Ineligible based on decision of an investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pCR rate in HSD17B4-hypermethylated breast cancer