NCT05969184

Palbociclib Combine With Anti-HER2 Therapy in Triple Positive ABC

Palbociclib Combine With Endocrine Therapy and Anti-HER2 Therapy in HR Positive and HER2 Positive Advanced Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to find out that if HER-2 positive and HR positive patients could benefit from trastuzumab and pertuzumab combined with palbociclib and endocrine therapy.

Detailed description

This study is a single-arm, open-label, multicenter, phase II clinical study. Subjects were eligible for screening and entered the trial period after enrollment and received treatment with palbociclib（125mg/day), trastuzumab(8 mg→6mg/every 3 week), pertuzumab(840 mg→420mg/every 3 week), combined with endocrine therapy until disease progression, or intolerable toxicity, or withdrawal of informed consent, or discontinuation of medication at the investigator 's discretion. On-study imaging assessments were performed according to RECIST 1.1 criteria and the site assessment was final.

Conditions

• Breast Neoplasm Female

Interventions

Type	Name	Description
DRUG	CDK4/6 inhibitor (Qilu),Trastuzumab (Hanquyou)	CDK4/6 inhibitor (Qilu) have got the cFDA approval and Trastuzumab (Hanquyou) have few data on combination use, this two drugs need clinical treatment data

Timeline

• Start date: 2021-12-25
• Primary completion: 2023-12-25
• Completion: 2024-12-25
• First posted: 2023-08-01
• Last updated: 2023-08-01

Locations

2 sites across 1 country: China