New triple-drug combo aims to keep advanced breast cancer in check
NCT ID NCT07470203
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether adding pyrotinib to two standard drugs (trastuzumab and pertuzumab) can help control HER2-positive advanced breast cancer longer. About 42 adults with advanced disease will receive this combination as maintenance therapy after initial treatment. The main goal is to see how long the cancer stays under control without growing.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years, male or female. 2. Histologically or cytologically confirmed HER2-positive advanced breast cancer (IHC 3+, or IHC 2+ with ISH amplification), with known HR status. 3. 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. 4. 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. 5. 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 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 7. Have planned to receive maintenance anti-tumor therapy with pyrotinib in combination with HP 8. 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. 9. Voluntary participation with written informed consent obtained prior to any study-related procedures. Exclusion Criteria: 1. Other malignancy diagnosed within 5 years prior to enrollment. 2. Prior treatment with any tyrosine kinase inhibitor targeting HER2 and/or epidermal growth factor receptor (EGFR) including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib. 3. Patients who are difficult or unable to be followed-up. 4. Other reasons that, in the investigator's judgment, make the patient unsuitable for participation in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a PI3K inhibitor boost presurgery breast cancer treatment?
- Can a platform trial match the right drug combo to each tumor?
- Can a shorter treatment hold off small HER2-Positive breast cancers?
- Can a Double-Pronged antibody outsmart HER2-Positive tumors?
- Can a vaccine teach the immune system to fight HER2-Positive tumors?
- Can a tailored Pre-Surgery regimen boost complete remission in HER2+ breast cancer?