The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).

Sponsor
Hebei Medical University Fourth Hospital
Study ID
NCT06217185
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Pyrotinib — DRUG
    Pyrotinib 400mg qd po continuously
  • Trastuzumab — DRUG
    For Trastuzumab, the loading dose for the first treatment cycle is 8 mg/kg, and for subsequent cycles, 6 mg/kg. It is to be used once every three weeks
  • Taxanes — DRUG
    Taxanes: Usual clinical dose is administered, in a 21-day cycle.
  • Capecitabine — DRUG
    Capecitabine: 650mg/m2 each time, given twice daily

Study Details

This is a multi-center real-world study, in which patients who meet the inclusion criteria will receive treatment with Pyrotinib + Trastuzumab + Taxanes. Taxanes will be used for 6-8 cycles or discontinued due to intolerable Adverse Events (AEs), after which Capecitabine will be used for rhythmic chemotherapy combined with Pyrotinib + Trastuzumab. The aim is to explore the efficacy and safety of Pyrotinib, Trastuzumab, and Taxanes in treating Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).

Key Dates

First listed
Jan 22, 2024
Start date
Jan 2, 2024
Status verified
Nov 2023
Primary completion
Dec 11, 2025
Completion
Jun 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental arm
    Pyrotinib, Trastuzumab Combined With Taxanes \*When taxane drugs are discontinued (after completing 6-8 cycles of treatment or due to intolerance), the therapy can be continued with the combination of metronomic capecitabine and trastuzumab, along with pyrotinib.

Primary Outcome Measure

PFS [ Time Frame: 24months ]

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