KBCSG-TR2220

Sequential Strategy Based on Endocrine Therapy after CDK4/6 Inhibitor in patients with HR-positive HER2-negative locally advanced or metastatic breast cancer : A Randomized Multicenter Phase II trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1051230031

Enrollment

150

Registered

2023-06-02

Start date

2023-06-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HR-positive/HER2-negative locally advanced or metastatic breast cancer locally advanced metastatic breast cancer, CDK4/6 inhibitor

Interventions

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 endoc

post CDK4/6 inhibitor, sequece of therapies

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria: Patients with past history of ILD during the first line therapy

Design outcomes

Primary

Measure	Time frame
Time to failure of strategy (TFS)	—

Secondary

Measure	Time frame
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	—

Contacts

Public ContactYoshinami Tetsuhiro

Osaka University Hospital

t2hr_y@yahoo.co.jp+81-6-6879-3772

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026