NCT07014410
Pyrotinib Combined With Dalpiciclib Combined With Letrozole in ER-positive and HER2-positive Advanced Breast Cancer
Recruiting · Phase 2 · Zhejiang Cancer Hospital · registry updated 2025-06-11
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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
- 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