Pyrotinib Combined With Dalpiciclib Combined With Letrozole in ER-positive and HER2-positive Advanced Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: pyrotinib dalpiciclib letrozole.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Drug pyrotinib dalpiciclib letrozole
ER positive HER2 positive advanced breast cancer patients are given pyrotinib+dalpiciclib+letrozole
Primary outcome measures
- Objective response rate [Time frame: through study completion, an average of 2 year]
Secondary outcome measures (1)
- Progression Free Survival [Time frame: through study completion, an average of 2 year]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhejiang Cancer Hospital — Hangzhou
Identifiers
NCT: NCT07014410 · DAPYLET