HER2-positive Breast Cancer, Metastatic Breast Cancer
Conditions
Brief summary
This is a prospective, open-label, multi-cohort, phase II study to evaluate the efficacy and safety of Oral metronomic capecitabine combined with pyrotinib in patients with HER2-positive advanced breast cancer who had received prior anti-HER2 ADC drugs (including T-DXd, SHR-A1811, T-DM1, etc.) before treatment.
Interventions
DRUGPyrotinib
400mg or 320mg qd
DRUGCapecitabine
500mg tid
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged ≥18 and ≤75 years. 2. Histologically or cytologically confirmed HER2-positive metastatic breast cancer. 3. Patients must have either experienced disease progression following anti-HER2 antibody-drug conjugate (ADC) therapy in the advanced/metastatic setting (including regimens containing SHR-A1811, T-DXd, T-DM1, or other approved ADCs) or discontinued prior anti-HER2 ADC treatment due to intolerable toxicity, financial constraints, or patient preference without evidence of disease progression. 4. ECOG performance status of 0 to 2. 5. The functions of the main organs are basically normal 6. Signed informed consent
Exclusion criteria
1. Prior treatment with a TKI or capecitabine (or other fluoropyrimidine-based chemotherapy) in the advanced or metastatic setting. 2. Known dihydropyrimidine dehydrogenase (DPD) deficiency. 3. Pregnant or lactating patients; 4. Malignancy (except basal cell carcinoma of the skin, which has been cured, and carcinoma in situ of the cervix) in the past 5 years; 5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications; 6. Serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study or interfere with the study results 7. Deemed by the investigator to be ineligible for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) | The observation period related to this endpoint is up to 36 months. |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) | The observation period related to this endpoint is up to 36 months. |
| Clinical Benefit Rate (CBR) | The observation period related to this endpoint is up to 36 months. |
| Overall Survival (OS) | The observation period related to this endpoint is up to 36 months. |
| Safety(adverse Events [AEs] and Serious Adverse Events [SAEs]) | From consent through 28 days following treatment completion |
Outcome results
None listed