Pyrotinib Maleate, CDK4/6 Inhibitor and Letrozole in Combination for Stage II-III TPBC: a Phase II Trial

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

89

Participants

Timeline

Start Date

July 27, 2020

Primary Completion Date

December 1, 2026

Study Completion Date

December 30, 2026

Conditions
Breast Cancer
Interventions
DRUG

Pyrotinib maleate, SHR6390, letrozole

After providing written informed consent, the participants will undergo combined treatment of pyrotinib maleate, CDK4/6 inhibitor SHR6390, and letrozole. The effectiveness of the combined treatment will be evaluated by MRI every two treatment cycles. If the disease progresses, the participant will withdraw from the trial. If the combined treatment has identified effectiveness, the participant will undergo surgical treatment within 4 weeks (over 2 weeks) after termination of the neoadjuvant treatment. The patients will be followed up for 5 years.

Trial Locations (1)

110004

Shengjing Hospital of China Medical University, Shenyang

All Listed Sponsors
lead

Shengjing Hospital

OTHER