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
1 other identifier
interventional
63
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 breast-cancer
Started Feb 2023
Longer than P75 for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2023
CompletedFirst Submitted
Initial submission to the registry
May 5, 2023
CompletedFirst Posted
Study publicly available on registry
June 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
June 11, 2025
June 1, 2025
4.9 years
May 5, 2023
June 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response rate
the proportion of patients achieving complete response or partial response
through study completion, an average of 2 year
Secondary Outcomes (1)
Progression Free Survival
through study completion, an average of 2 year
Study Arms (1)
pyrotinib dalpiciclib letrozole
EXPERIMENTALPatients receive pyrotinib 320mg/d, dalpiciclib 125mg/d and letrozole 2.5mg/d until disease progression, intolerated toxicity.
Interventions
ER positive HER2 positive advanced breast cancer patients are given pyrotinib+dalpiciclib+letrozole
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhanhong Chen, Master
Zhejiang Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 5, 2023
First Posted
June 11, 2025
Study Start
February 1, 2023
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2029
Last Updated
June 11, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share