NCT07600164 Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer
| NCT ID | NCT07600164 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking University People's Hospital |
| Condition | HER2 + Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-07-06 |
| Primary Completion | 2031-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 500 participants in total. It began in 2026-07-06 with a primary completion date of 2031-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Aged ≥ 18 years old; 2. Histopathologically confirmed HER2-positive inoperable locally advanced or metastatic breast cancer; 3. Patients with first-line or second-line advanced disease: First-line advanced disease: no prior systemic therapy for locally advanced or metastatic disease. For patients who received neoadjuvant or adjuvant therapy, the disease-free interval (DFI) after the completion of the last chemotherapy or HER2-targeted therapy was more than 12 months; Second-line advanced disease: prior treatment with taxane combined with trastuzumab, with or without pertuzumab, in the advanced setting; or recurrence occurring during neoadjuvant/adjuvant therapy, or a disease-free interval (DFI) of ≤ 12 months after completion of the last neoadjuvant/adjuvant chemotherapy and HER2-targeted therapy; 4. 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; 5. Traceable medical records available throughout the treatment period. Exclusion Criteria: 1. Failure to sign the informed consent form; 2. Pregnant or lactating females; 3. Patients participating in any interventional clinical trial involving investigational drugs or marketed drugs at enrollment; 4. Other conditions deemed ineligible for enrollment by the investigator's judgment.
Contact & Investigator
wang shu
STUDY CHAIR
Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT07600164 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HER2 + Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07600164 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07600164 currently recruiting?
Yes, NCT07600164 is actively recruiting participants. Contact the research team at 13671287670@163.com for enrollment information.
Where is the NCT07600164 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07600164 clinical trial?
NCT07600164 is sponsored by Peking University People's Hospital. The principal investigator is wang shu at Peking University People's Hospital. The trial plans to enroll 500 participants.
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