Breast Cancer
Conditions
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.
Interventions
DRUGpyrotinib dalpiciclib letrozole
ER positive HER2 positive advanced breast cancer patients are given pyrotinib+dalpiciclib+letrozole
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | through study completion, an average of 2 year | the proportion of patients achieving complete response or partial response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | through study completion, an average of 2 year | Time to progression or death, which comes first |
Countries
China
Contacts
Primary ContactZhiqiang Xiao, Master
Backup ContactZhiqiang Xiao
Outcome results
None listed