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

NCT07019337 | Not Yet Recruiting Phase 2

• 1 other identifier: MA-BC-II-112
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  The observation period related to this endpoint is up to 36 months.

Secondary Outcomes (4)

• 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

Study Arms (2)

pyrotinib plus capecitabine

EXPERIMENTAL

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.

Drug: Pyrotinib; Drug: Capecitabine

pyrotinib and capecitabine

EXPERIMENTAL

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.

Drug: Pyrotinib; Drug: Capecitabine

Interventions

Pyrotinib DRUG

400mg or 320mg qd

pyrotinib and capecitabine; pyrotinib plus capecitabine

Capecitabine DRUG

500mg tid

pyrotinib and capecitabine; pyrotinib plus capecitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pyrotinib; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Medical Oncology

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 13, 2025

Record last verified: 2025-05