Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HER2-positive Breast Cancer
• Intervention / Treatment: Drug: Pertuzumab; Drug: Combination product: Trastuzumab + Pertuzumab; Drug: Pyrotinib; Drug: Trastuzuma

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 Type: Observational
• Enrollment (Estimated): 42

Contacts and Locations

• Study Contact: Name: Guohong Song; Phone Number: 010-8819 6406; Email: songguohong918@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events		Start of treatment until 3-year follow-up
Severity of adverse events		Start of treatment until 3-year follow-up
Incidence of serious adverse events		Start of treatment until 3-year follow-up
Severity of serious adverse events		Start of treatment until 3-year follow-up
Overall survival (OS)	The time from the date the patient begins treatment to death from any cause.	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	Up to approximately 3 years

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: HER2-positive breast cancer; pyrotinib
• Additional Relevant MeSH Terms: pertuzumab; pyrotinib
• Other Study ID Numbers: Pyro-HP Maintain

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No