Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University People's Hospital
About this trial
Given that pyrotinib has been proven to exert significant efficacy against HER2-positive advanced breast cancer in multiple Phase III studies, and the novel ADC drug disitamab vedotin has demonstrated potent anti-tumor activity, there remains insufficient real-world data on their sequential administration. This multicenter, prospective real-world study plans to enroll 500 patients with HER2-positive advanced breast cancer receiving first-line or second-line treatment. It aims to evaluate the efficacy and safety of sequential disitamab vedotin treatment after disease progression or intolerance to pyrotinib-based regimens (first-line: pyrotinib plus trastuzumab combined with chemotherapy; second-line: pyrotinib plus capecitabine). The primary endpoint is real-world second progression-free survival (rwPFS2), while secondary endpoints cover real-world progression-free survival (rwPFS), tumor response, overall survival (OS), time to treatment failure, safety profiles and patient-reported outcomes. It is currently expected to further validate the efficacy and safety of pyrotinib in patients with advanced HER2-positive breast cancer in the real-world setting, and to evaluate the efficacy and safety of recindopril trastuzumab following pyrotinib-containing regimens.
Eligibility criteria
Qualifiers
Aged ≥ 18 years old;
Histopathologically confirmed HER2-positive inoperable locally advanced or metastatic breast cancer;
Planned to receive pyrotinib-containing regimen, and judged by investigators based on clinical practice to have potential subsequent treatment with Ruikang trastuzumab after failure of pyrotinib-containing therapy;
Traceable medical records available throughout the treatment period.
Disqualifiers
Failure to sign the informed consent form;
Pregnant or lactating females;
Patients participating in any interventional clinical trial involving investigational drugs or marketed drugs at enrollment;
Other conditions deemed ineligible for enrollment by the investigator's judgment.
Trial design
Treatments tested in this trial
- Pyrotinib
- Trastuzumab Rezetecan
Treatment groups
500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov