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

Recruiting now · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT07014410

Run by

Zhejiang Cancer Hospital

People needed

63

Starts

2023-02-01

Expected to finish

2029-12-31

Last updated by the study team

2025-06-11

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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