HER2 + Breast CancerPhase 4NCT07600164
Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer
A Phase 4 study testing Pyrotinib and Trastuzumab Rezetecan in people with HER2 + Breast Cancer and Advanced Breast Cancer, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2 + Breast Cancer, Advanced Breast Cancer
- What is being tested?
- Pyrotinib and Trastuzumab Rezetecan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2026to 30 Dec 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years old;
- Histopathologically confirmed HER2-positive inoperable locally advanced or metastatic breast cancer;
- 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;
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
yuan peng, 86+13671287670, 13671287670@163.com
About this study
Official title: Real-world Study of Pyrotinib-containing Regimens in First-line or Second-line Treatment of Advanced HER2-positive Breast Cancer
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.
- Conditions
- HER2 + Breast Cancer, Advanced Breast Cancer
- Being tested
- Pyrotinib, Trastuzumab Rezetecan
- Keywords
- HER2-positive breast cancer, Advanced breast cancer, pyrotinib, Trastuzumab Rezetecan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyrotinibDrug
Pyrotinib: 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 RezetecanDrug
Trastuzumab Rezetecan: administered intravenously at a dose of 4.8 mg/kg on Day 1 of each cycle, with a 21-day treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | This cohort consists of patients with first-line advanced disease. First-line advanced disease is defined as no prior systemic therapy administered for locally advanced or metastatic disease. For patients who have received neoadjuvant or adjuvant therapy, the disease-free interval (DFI) after the completion of the last chemotherapy or HER2-targeted therapy must be longer than 12 months. First-line patients receive treatment with pyrotinib plus trastuzumab combined with chemotherapy. Upon disease progression or intolerance to pyrotinib-containing regimens, subsequent treatment with Trastuzumab Rezetecan will be administered. Receives: Drug: Pyrotinib; Drug: Trastuzumab Rezetecan |
| Cohort B | Experimental | This cohort includes patients with second-line advanced breast cancer. Second-line advanced disease is defined as prior receipt of taxane combined with trastuzumab, with or without pertuzumab, in the advanced setting; or disease recurrence during neoadjuvant/adjuvant therapy, or a disease-free interval (DFI) of ≤ 12 months after completion of the last cycle of neoadjuvant/adjuvant chemotherapy and HER2-targeted therapy. Patients in the second-line setting are treated with pyrotinib plus capecitabine. Following disease progression or intolerance to pyrotinib-containing regimens, subsequent treatment with Trastuzumab Rezetecan is administered. Receives: Drug: Pyrotinib; Drug: Trastuzumab Rezetecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (4)
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.
Measured: 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.
OS
Overall Survival (OS): defined as the time from the initiation of the study treatment regimen to death from any cause.
Measured: From the initiation of the study treatment regimen to death from any cause，assessed up to 60 months.
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.
Measured: From the initiation of the study treatment regimen until disease progression or study withdrawal，assessed up to 60 months.
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.
Measured: From the initiation of the study treatment regimen until disease progression or study withdrawal，assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start6 Jul 2026
- Primary completion30 Dec 2031 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 + Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu Wang, Peking University People's Hospital
- Investigators
- wang shu, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600164
- Sponsor's protocol ID
- MA-BC-RWS-141
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Study of Pyrotinib-containing Regimens in First-line or Second-line Treatment of Advanced HER2-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT07600164
- Acronym / sponsor ID
- MA-BC-RWS-141
- Conditions
- HER2 + Breast Cancer, Advanced Breast Cancer
- Keywords
- HER2-positive breast cancer, Advanced breast cancer, pyrotinib, Trastuzumab Rezetecan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- 30 Dec 2031 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Pyrotinib, Drug: Trastuzumab RezetecanThis cohort consists of patients with first-line advanced disease. First-line advanced disease is defined as no prior systemic therapy administered for locally advanced or metastatic disease. For patients who have received neoadjuvant or adjuvant therapy, the disease-free interval (DFI) after the completion of the last chemotherapy or HER2-targeted therapy must be longer than 12 months. First-line patients receive treatment with pyrotinib plus trastuzumab combined with chemotherapy. Upon disease progression or intolerance to pyrotinib-containing regimens, subsequent treatment with Trastuzumab Rezetecan will be administered. |
| Cohort B | Experimental | Drug: Pyrotinib, Drug: Trastuzumab RezetecanThis cohort includes patients with second-line advanced breast cancer. Second-line advanced disease is defined as prior receipt of taxane combined with trastuzumab, with or without pertuzumab, in the advanced setting; or disease recurrence during neoadjuvant/adjuvant therapy, or a disease-free interval (DFI) of ≤ 12 months after completion of the last cycle of neoadjuvant/adjuvant chemotherapy and HER2-targeted therapy. Patients in the second-line setting are treated with pyrotinib plus capecitabine. Following disease progression or intolerance to pyrotinib-containing regimens, subsequent treatment with Trastuzumab Rezetecan is administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥ 18 years old;
- Histopathologically confirmed HER2-positive inoperable locally advanced or metastatic breast cancer;
- 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;
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PyrotinibPyrotinib: 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. | Drug | Cohort A, Cohort B |
| Trastuzumab RezetecanTrastuzumab Rezetecan: administered intravenously at a dose of 4.8 mg/kg on Day 1 of each cycle, with a 21-day treatment cycle. | Drug | Cohort A, Cohort B |
Primary outcome
rwPFS2
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.
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.
4 secondary outcomes
rwPFS
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.
OS
Time frame: From the initiation of the study treatment regimen to death from any cause，assessed up to 60 months.
rwORR
Time frame: From the initiation of the study treatment regimen until disease progression or study withdrawal，assessed up to 60 months.
rwTTF
Time frame: From the initiation of the study treatment regimen until disease progression or study withdrawal，assessed up to 60 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
wang shu study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pyrotinib and Trastuzumab Rezetecan in people with HER2 + Breast Cancer and Advanced Breast Cancer, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact peng yuan (86+13671287670, 13671287670@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rwPFS2 (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.