KBCSG-TR2220

JRCT ID: jRCT1051230031

Registered date:02/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: HR-positive/HER2-negative locally advanced or metastatic breast cancer
• Date of first enrollment: 02/06/2023
• Target sample size: 150
• Study type: Interventional

Intervention(s)

Sequence of CDK4/6 inhibitor + unused endocrine therapy followed by everoliumus +unused endocrine therapy
Sequence of everolimus + unused endocrine therapy followed by CDK4/6 inhibitor +unused endocrine therapy

Outcome(s)

• Primary Outcome: Time to failure of strategy (TFS)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female
• Include 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.
• Exclude criteria: Patients with past history of ILD during the first line therapy

Related Information

• Primary Sponsor: Takahiro Nakayama
• Source(s) of Monetary Support: Sysmex