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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Pyrotinib
DrugPyrotinib: administered orally once daily at a dose of 400 mg, 320 mg or 240 mg within 30 minutes after breakfast. A continuous administration of 21 days is defined as one treatment cycle. The dosage of pyrotinib will be adjusted by physicians according to the individual clinical conditions. Concomitant chemotherapeutic agents and other supportive care treatments are determined at the investigators' discretion in accordance with clinical practice guidelines and drug instructions.
Trastuzumab Rezetecan
DrugTrastuzumab Rezetecan: administered intravenously at a dose of 4.8 mg/kg on Day 1 of each cycle, with a 21-day treatment cycle.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Cohort AExperimental treatment 2 interventions
Group B: Cohort BExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
rwPFS2
Second assessment of real-world progression-free survival (rwPFS2): defined as the time (in months) from the initial administration of pyrotinib-containing regimens (first-line pyrotinib combined with trastuzumab plus chemotherapy, or second-line pyrotinib combined with capecitabine) to disease progression or death after the initiation of subsequent Trastuzumab Rezetecan therapy.
Time frame
From the start of first administration of pyrotinib-containing regimen (first-line or second-line) until disease progression or death occurring after the initiation of subsequent trastuzumab Rezetecan therapy，assessed up to 60 months.Secondary outcomes
1
rwPFS
Real-world progression-free survival (rwPFS): defined as the time from the initial initiation of pyrotinib treatment to disease progression, death, or switch to Trastuzumab Rezetecan due to intolerable toxicity.
Time frame
From the start of initial pyrotinib treatment until the occurrence of disease progression, death, or switch to trastuzumab rezetecan due to intolerable toxicity，assessed up to 60 months.2
OS
Overall Survival (OS): defined as the time from the initiation of the study treatment regimen to death from any cause.
Time frame
From the initiation of the study treatment regimen to death from any cause，assessed up to 60 months.3
rwORR
Real-world Objective Response Rate (rwORR): refers to the percentage of subjects with a best overall response of CR or PR from the initiation of the study treatment regimen until disease progression and study withdrawal, among the total number of subjects in the analysis set.
Time frame
From the initiation of the study treatment regimen until disease progression or study withdrawal，assessed up to 60 months.4
rwTTF
Real-world Time to Treatment Failure (rwTTF): defined as the time from the date of treatment initiation to treatment discontinuation for any reason, including but not limited to disease progression, death, adverse drug reactions/toxicity, patient preference, and initiation of subsequent-line therapy.
Time frame
From the initiation of the study treatment regimen until disease progression or study withdrawal，assessed up to 60 months.Sponsors and contacts
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Source ClinicalTrials.gov