Oral Metronomic Capecitabine Combined With Pyrotinib in ADC-treated HER2-positive Metastatic Breast Cancer

Phase 2

Not yet recruiting

• Conditions: HER2-positive Breast Cancer; Metastatic Breast Cancer
• Interventions: Drug: Pyrotinib; Drug: Capecitabine

• Registration Number: NCT07019337
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Study Start: 2025-06-30
• Primary Completion: 2028-07-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pyrotinib plus capecitabine	Pyrotinib	Patients who experienced disease progression (PD) following front-line treatment with an ADC-based regimen received pyrotinib in combination with metronomic capecitabine until disease progression or unacceptable toxicity.
pyrotinib plus capecitabine	Capecitabine	Patients who experienced disease progression (PD) following front-line treatment with an ADC-based regimen received pyrotinib in combination with metronomic capecitabine until disease progression or unacceptable toxicity.
pyrotinib and capecitabine	Pyrotinib	Patients without disease progression who discontinued front-line ADC therapy due to intolerable toxicity, economic reasons, or patient preference were enrolled and received pyrotinib plus metronomic capecitabine until disease progression or unacceptable toxicity.
pyrotinib and capecitabine	Capecitabine	Patients without disease progression who discontinued front-line ADC therapy due to intolerable toxicity, economic reasons, or patient preference were enrolled and received pyrotinib plus metronomic capecitabine until disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	The observation period related to this endpoint is up to 36 months.

Secondary Outcome Measures

Name	Time	Method
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