Pyrotinib and Disitamab for Advanced HER2-positive Breast Cancer
Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer
Recruiting
Phase 4Interventional Study
HER2 + Breast CancerAdvanced Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
500 (estimated)
Sponsor
Peking University People's Hospital · Other
Who this trial is looking for
This trial is looking for patients with advanced HER2-positive breast cancer who are receiving treatment. Participants will be evaluated for how well the treatments work and their safety.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years old or older.
I have advanced breast cancer that is HER2-positive.
I have not had systemic therapy for my advanced cancer before (first-line).
I have had prior treatment with taxane and trastuzumab (second-line).
I am planned to receive a regimen that includes pyrotinib.
I have good medical records available.
You may not be able to join if
I have not signed the informed consent form.
I am pregnant or breastfeeding.
I am participating in another clinical trial.
I have other conditions that my doctor thinks makes me ineligible.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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-positi…
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.
Trial Locations
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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 metasta…
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.
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