Clinical trial NCT07019337: Oral Metronomic Capecitabine Combined With Pyrotinib in ADC-treated HER2-positive Metastatic Breast Cancer
Official title: Oral Metronomic Capecitabine Combined With Pyrotinib in ADC-treated HER2-positive Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: HER2-positive Breast Cancer
Metastatic Breast Cancer
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: The observation period related to this endpoint is up to 36 months.
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: The observation period related to this endpoint is up to 36 months.
measure: Clinical Benefit Rate (CBR)
timeFrame: The observation period related to this endpoint is up to 36 months.
measure: Overall Survival (OS)
timeFrame: The observation period related to this endpoint is up to 36 months.
measure: Safety(adverse Events [AEs] and Serious Adverse Events [SAEs])
timeFrame: From consent through 28 days following treatment completion
Other outcomes:
Locations:
Study officials:
References: