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

Phase 2

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: pyrotinib dalpiciclib letrozole

• Registration Number: NCT07014410
• Lead Sponsor: Zhejiang Cancer Hospital

Brief 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.

Detailed Description

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. Patients receive pyrotinib 320mg/d, dalpiciclib 125mg/d, d1-21, q28d. One cycle is 28d.

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-05-05
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study First Posted: 2025-06-11
• Last Update Posted: 2025-06-11
• Primary Completion: 2027-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pyrotinib dalpiciclib letrozole	pyrotinib dalpiciclib letrozole	Patients receive pyrotinib 320mg/d, dalpiciclib 125mg/d and letrozole 2.5mg/d until disease progression, intolerated toxicity.

Primary Outcome Measures

Name	Time	Method
Objective response rate	through study completion, an average of 2 year	the proportion of patients achieving complete response or partial response

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	through study completion, an average of 2 year	Time to progression or death, which comes first

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China