KBCSG-TR2220

Phase 2

Recruiting

• Conditions: HR-positive/HER2-negative locally advanced or metastatic breast cancer; locally advanced metastatic breast cancer, CDK4/6 inhibitor; Breast Neoplasms

• Registration Number: JPRN-jRCT1051230031
• Lead Sponsor: Takahiro Nakayama

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

Patients with HR-positive/HER2-negative locally advanced or metastatic breast cancer resistance to first-line therapy with endocrine therapy and CDK4/6 inhibitors.

Exclusion Criteria

Patients with past history of ILD during the first line therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to failure of strategy (TFS)

Secondary Outcome Measures

Name	Time	Method
Key secondary endpoint: Rate of successful sequence therapy<br>Secondary endpoint:<br>Time to chemotherapy<br>Objective response rate<br>Progression-free survival<br>Overall survival<br>Rate of ILD <br>Relationship between biomarkers and efficacy<br>Utility of ctDNA analysis<br>Safety