HER2-positive Breast CancerNCT07470203
Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer
An observational study of HER2-positive Breast Cancer, run by Peking University Cancer Hospital & Institute.
Trial summary
This is a Prospective, Single-Arm, Observational, Real-World Study. The purpose of this study is to evaluate the safety and efficacy of pyrotinib combined with trastuzumab and pertuzumab for maintenance therapy in HER2-positive advanced breast cancer in the real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Pyrotinib, Trastuzuma and Pertuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2026to 30 Sep 2029
- Phase
- Observational
- 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
Study population: The study population consists of adult patients (age ≥18) with HER2-positive advanced breast cancer who have completed 4-8 cycles of first-line induction therapy with trastuzumab, pertuzumab, and chemotherapy without disease progression. Participants will be recruited from the Department of Breast Oncology at Peking University Cancer Hospital and will be enrolled consecutively after meeting all eligibility criteria and providing informed consent.
Who may be able to join
- Age ≥ 18 years, male or female.
- Histologically or cytologically confirmed HER2-positive advanced breast cancer (IHC 3+, or IHC 2+ with ISH amplification), with known HR status.
- Have unresectable locally advanced or metastatic disease. If recurrent (after [neo]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab and pertuzumab received in the early breast cancer setting for advanced HER2+ disease.
- Have received 4-8 cycles of pre-study induction therapy including only trastuzumab, pertuzumab, and taxane as first-line of therapy for the treatment of advanced breast cancer prior to study enrollment. Participants are eligible provided they are without evidence of disease progression following completion of induction therapy.
- CNS Inclusion - Based on screening contrast-enhanced brain magnetic resonance imaging (MRI), participants may have any of the following: No evidence of brain metastases. Untreated brain metastases which are asymptomatic not needing immediate local treatment and, if identified on prior brain imaging, without evidence of progression since starting first-line induction therapy with trastuzumab, pertuzumab, and taxane
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Show all 9Show fewer
- Have planned to receive maintenance anti-tumor therapy with pyrotinib in combination with HP
- Negative serum pregnancy test; women of childbearing potential must use a highly effective contraceptive method from study initiation until at least 6 months after the last dose of study medication.
- Voluntary participation with written informed consent obtained prior to any study-related procedures.
Who cannot join
- Other malignancy diagnosed within 5 years prior to enrollment.
- Prior treatment with any tyrosine kinase inhibitor targeting HER2 and/or epidermal growth factor receptor (EGFR) including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib.
- Patients who are difficult or unable to be followed-up.
- Other reasons that, in the investigator's judgment, make the patient unsuitable for participation in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer：A Prospective, Single-Arm, Observational, Real-World Study
This is a Prospective, Single-Arm, Observational, Real-World Study. The purpose of this study is to evaluate the safety and efficacy of pyrotinib combined with trastuzumab and pertuzumab for maintenance therapy in HER2-positive advanced breast cancer in the real-world setting.
Read the detailed description
The current standard of care for first-line treatment of HER2+ advanced breast cancer consists of induction chemotherapy with a taxane (T) in combination with dual anti-HER2 monoclonal antibody, trastuzumab (H) and pertuzumab (P), followed by maintenance therapy with HP. However, most patients eventually experience disease progression on this regimen and not all will be able to receive a second-line treatment. The aim of this study was to evaluate the efficacy and safety of pyrotinib combined with HP as maintenance therapy for HER2-positive advanced breast cancer patients. The results are expected to provide real-world evidence for optimizing first-line maintenance treatment strategies in patients with HER2+ advanced breast cancer who had completed induction therapy with THP.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- Pyrotinib, Trastuzuma, Pertuzumab, Combination product: Trastuzumab + Pertuzumab
- Keywords
- pyrotinib, HER2-positive breast cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyrotinibDrug
240~320mg given by mouth (orally) once daily every 21days
TrastuzumaDrug
6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
PertuzumabDrug
420mg given by IV every 21 days
Combination product: Trastuzumab + PertuzumabDrug
600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days. May be given in place of trastuzumab and pertuzumab individually.
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
The time from the patient begins treatment to the investigator assessment of disease progression according to RECIST v1.1 or death from any cause
Measured: Up to approximately 3 years
Secondary outcomes (6)
Overall survival (OS)
The time from the date the patient begins treatment to death from any cause.
Measured: Up to approximately 5 years
Central nervous system (CNS) PFS
The time from the patient begins treatment to investigator assessed disease progression in brain (RECIST v1.1), or death from any cause
Measured: Up to approximately 3 years
Incidence of adverse events
Measured: Start of treatment until 3-year follow-up
Severity of adverse events
Measured: Start of treatment until 3-year follow-up
Incidence of serious adverse events
Measured: Start of treatment until 3-year follow-up
Severity of serious adverse events
Measured: Start of treatment until 3-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start31 Mar 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470203
- Sponsor's protocol ID
- Pyro-HP Maintain
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer：A Prospective, Single-Arm, Observational, Real-World Study
- ClinicalTrials.gov ID
- NCT07470203
- Acronym / sponsor ID
- Pyro-HP Maintain
- Conditions
- HER2-positive Breast Cancer
- Keywords
- pyrotinib, HER2-positive breast cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 13 Mar 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.
This is a Prospective, Single-Arm, Observational, Real-World Study. The purpose of this study is to evaluate the safety and efficacy of pyrotinib combined with trastuzumab and pertuzumab for maintenance therapy in HER2-positive advanced breast cancer in the real-world setting.
Detailed description
The current standard of care for first-line treatment of HER2+ advanced breast cancer consists of induction chemotherapy with a taxane (T) in combination with dual anti-HER2 monoclonal antibody, trastuzumab (H) and pertuzumab (P), followed by maintenance therapy with HP. However, most patients eventually experience disease progression on this regimen and not all will be able to receive a second-line treatment. The aim of this study was to evaluate the efficacy and safety of pyrotinib combined with HP as maintenance therapy for HER2-positive advanced breast cancer patients. The results are expected to provide real-world evidence for optimizing first-line maintenance treatment strategies in patients with HER2+ advanced breast cancer who had completed induction therapy with THP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (age ≥18) with HER2-positive advanced breast cancer who have completed 4-8 cycles of first-line induction therapy with trastuzumab, pertuzumab, and chemotherapy without disease progression. Participants will be recruited from the Department of Breast Oncology at Peking University Cancer Hospital and will be enrolled consecutively after meeting all eligibility criteria and providing informed consent.
Key inclusion criteria (9 listed)
- Age ≥ 18 years, male or female.
- Histologically or cytologically confirmed HER2-positive advanced breast cancer (IHC 3+, or IHC 2+ with ISH amplification), with known HR status.
- Have unresectable locally advanced or metastatic disease. If recurrent (after [neo]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab and pertuzumab received in the early breast cancer setting for advanced HER2+ disease.
- Have received 4-8 cycles of pre-study induction therapy including only trastuzumab, pertuzumab, and taxane as first-line of therapy for the treatment of advanced breast cancer prior to study enrollment. Participants are eligible provided they are without evidence of disease progression following completion of induction therapy.
- CNS Inclusion - Based on screening contrast-enhanced brain magnetic resonance imaging (MRI), participants may have any of the following: No evidence of brain metastases. Untreated brain metastases which are asymptomatic not needing immediate local treatment and, if identified on prior brain imaging, without evidence of progression since starting first-line induction therapy with trastuzumab, pertuzumab, and taxane
Key exclusion criteria (4 listed)
- Other malignancy diagnosed within 5 years prior to enrollment.
- Prior treatment with any tyrosine kinase inhibitor targeting HER2 and/or epidermal growth factor receptor (EGFR) including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib.
- Patients who are difficult or unable to be followed-up.
- Other reasons that, in the investigator's judgment, make the patient unsuitable for participation in this study.
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 |
|---|---|---|
| Pyrotinib240~320mg given by mouth (orally) once daily every 21days | Drug | – |
| Trastuzuma6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days | Drug | – |
| Pertuzumab420mg given by IV every 21 days | Drug | – |
| Combination product: Trastuzumab + Pertuzumab600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days. May be given in place of trastuzumab and pertuzumab individually. | Drug | – |
Primary outcome
Progression-free survival (PFS)
Time frame: Up to approximately 3 years
The time from the patient begins treatment to the investigator assessment of disease progression according to RECIST v1.1 or death from any cause
6 secondary outcomes
Overall survival (OS)
Time frame: Up to approximately 5 years
Central nervous system (CNS) PFS
Time frame: Up to approximately 3 years
Incidence of adverse events
Time frame: Start of treatment until 3-year follow-up
Severity of adverse events
Time frame: Start of treatment until 3-year follow-up
Incidence of serious adverse events
Time frame: Start of treatment until 3-year follow-up
Severity of serious adverse events
Time frame: Start of treatment until 3-year follow-up
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 Mar 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2-positive Breast Cancer, run by Peking University Cancer Hospital & Institute.
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 9 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: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Guohong Song (010-8819 6406, songguohong918@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Up to approximately 3 years). 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 Mar 2026.