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

NCT ID: NCT07019337

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2030-12-31

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.

Conditions

HER2-positive Breast Cancer; Metastatic Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pyrotinib plus 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.

Group Type: EXPERIMENTAL

Pyrotinib

Intervention Type: DRUG

400mg or 320mg qd

Capecitabine

Intervention Type: DRUG

500mg tid

pyrotinib and 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.

Group Type: EXPERIMENTAL

Pyrotinib

Intervention Type: DRUG

400mg or 320mg qd

Capecitabine

Intervention Type: DRUG

500mg tid

Interventions

Pyrotinib

400mg or 320mg qd

Intervention Type: DRUG

Capecitabine

500mg tid

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Ma Fei，MD

Department of Medical Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MA-BC-II-112

Identifier Type: -

Identifier Source: org_study_id