Not yet recruiting NCT07019337
Oral Metronomic Capecitabine Combined With Pyrotinib in ADC-treated HER2-positive Metastatic 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, Capecitabine.
- Who it may be relevant to
- Registry conditions: HER2-positive Breast Cancer, Metastatic Breast Cancer. Basic parameters: 18 years — 75 years · All.
- 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
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Drug Pyrotinib
400mg or 320mg qd - Drug Capecitabine
500mg tid
Primary outcome measures
- Progression Free Survival (PFS) [Time frame: The observation period related to this endpoint is up to 36 months.]
Secondary outcome measures (4)
- Objective response rate (ORR) [Time frame: The observation period related to this endpoint is up to 36 months.]
- Clinical Benefit Rate (CBR) [Time frame: The observation period related to this endpoint is up to 36 months.]
- Overall Survival (OS) [Time frame: The observation period related to this endpoint is up to 36 months.]
- Safety(adverse Events [AEs] and Serious Adverse Events [SAEs]) [Time frame: From consent through 28 days following treatment completion]
Eligibility criteria
Inclusion criteria
- Aged ≥18 and ≤75 years.
- Histologically or cytologically confirmed HER2-positive metastatic breast cancer.
- 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.
- ECOG performance status of 0 to 2.
- The functions of the main organs are basically normal
- Signed informed consent
Exclusion criteria
- Prior treatment with a TKI or capecitabine (or other fluoropyrimidine-based chemotherapy) in the advanced or metastatic setting.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Pregnant or lactating patients;
- Malignancy (except basal cell carcinoma of the skin, which has been cured, and carcinoma in situ of the cervix) in the past 5 years;
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications;
- Serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study or interfere with the study results
- Deemed by the investigator to be ineligible for participation in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07019337 · MA-BC-II-112