Pyrotinib Combined With Dalpiciclib Combined With Letrozole in ER-positive and HER2-positive Advanced Breast Cancer
NCT ID: NCT07014410
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
63 participants
INTERVENTIONAL
2023-02-01
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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pyrotinib dalpiciclib letrozole
Patients receive pyrotinib 320mg/d, dalpiciclib 125mg/d and letrozole 2.5mg/d until disease progression, intolerated toxicity.
pyrotinib dalpiciclib letrozole
ER positive HER2 positive advanced breast cancer patients are given pyrotinib+dalpiciclib+letrozole
Interventions
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pyrotinib dalpiciclib letrozole
ER positive HER2 positive advanced breast cancer patients are given pyrotinib+dalpiciclib+letrozole
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
FEMALE
No
Sponsors
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Zhejiang Cancer Hospital
OTHER
Responsible Party
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Chen Zhanhong
MD
Principal Investigators
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Zhanhong Chen, Master
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Zhanhong Chen
Role: primary
Other Identifiers
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DAPYLET
Identifier Type: -
Identifier Source: org_study_id
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