pyrotinib dalpiciclib letrozole: ER positive HER2 positive advanced breast cancer patients are given pyrotinib+dalpiciclib+letrozole
Study 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
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. The subjects voluntarily joined the study, signed the informed consent, and had good compliance
2. Postmenopausal or premenopausal/perimenopausal women aged ≥18 years and ≤75 years
3. Patients with recurrent/metastatic breast cancer confirmed by histopathology with positive ER expression and positive HER2 expression
4. Have at least one extracranial measurable lesion that meets RECIST 1.1 criteria
5. At most one previous trastuzumab containing systemic therapy for recurrent metastatic breast cancer
Exclusion Criteria:
1. Subjects had untreated central nervous system metastasis
2. Bilateral breast cancer, inflammatory breast cancer, or latent breast cancer
3. Previous treatment with any CDK4/6 inhibitors
4. Inability to swallow, intestinal obstruction, or other factors affecting drug use and absorption
5. 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
Primary outcome measure(s)
Objective response rate — through study completion, an average of 2 year the proportion of patients achieving complete response or partial response
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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