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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• Age: 18-70 years old, female;

• Pathological examination confirmed HER-2 positive invasive breast cancer; (HER2 positivity is defined as an immunohistochemical (IHC) score of 3+ or in-situ hybridization (ISH) result for HER2 gene amplification in \>10% of immunoreactive cells.

• HER2 positivity needs to be verified by the pathology department of the research center involved in this study)

• Imaging confirmed recurrent/metastatic breast cancer;

• Patients who relapsed and metastasized three months after discontinuation of Trastuzumab treatment;

• Have at least one measurable lesion (according to RECIST 1.1 criteria);

• ECOG score of 0-2;

• Expected life span ≥3 months;

• Normal major organ function;

• The researcher believes that the participant may benefit;

⁃ Volunteer to participate in this study, sign informed consent.

Locations
Other Locations
China
The Fourth Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Time Frame
Start Date: 2024-01-02
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Hebei Medical University Fourth Hospital

This content was sourced from clinicaltrials.gov

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