RecruitingPhase 2NCT07014410

Pyrotinib Combined With Dalpiciclib Combined With Letrozole in ER-positive and HER2-positive Advanced Breast Cancer

A Multicenter Phase II Clinical Study of Pyrotinib Combined With Dalpiciclib Combined With Letrozole in the Treatment of ER-positive and HER2-positive Advanced Breast Cancer

Sponsor

Zhejiang Cancer Hospital

Enrollment

63 participants

Start Date

Feb 1, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

This is a a multicenter Phase II clinical study investigating efficacy of pyrotinib combined with dalpiciclib combined with letrozole in ER-positive and HER2-positive advanced breast cancer patients. The sample size is 63.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

The subjects voluntarily joined the study, signed the informed consent, and had good compliance
Postmenopausal or premenopausal/perimenopausal women aged ≥18 years and ≤75 years
Patients with recurrent/metastatic breast cancer confirmed by histopathology with positive ER expression and positive HER2 expression
Have at least one extracranial measurable lesion that meets RECIST 1.1 criteria
At most one previous trastuzumab containing systemic therapy for recurrent metastatic breast cancer

Exclusion Criteria5

Subjects had untreated central nervous system metastasis
Bilateral breast cancer, inflammatory breast cancer, or latent breast cancer
Previous treatment with any CDK4/6 inhibitors
Inability to swallow, intestinal obstruction, or other factors affecting drug use and absorption
Subject has had other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within 5 years or at the same time