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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Not yet enrolling; Phase 2

Conditions: HER2-positive Breast Cancer; Metastatic Breast Cancer

Treatments: Drug: Capecitabine; Drug: Pyrotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT07019337

MA-BC-II-112

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

pyrotinib plus capecitabine

Experimental group

Description:

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.

Treatment:

Drug: Pyrotinib

Drug: Capecitabine

pyrotinib and capecitabine

Experimental group

Description:

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.

Treatment:

Drug: Pyrotinib

Drug: Capecitabine