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

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT07019337
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Pyrotinib — DRUG
    400mg or 320mg qd
  • Capecitabine — DRUG
    500mg tid

Study Details

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.

Key Dates

First listed
Jun 13, 2025
Start date
Jun 30, 2025
Status verified
May 2025
Primary completion
Jul 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: The observation period related to this endpoint is up to 36 months. ]

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