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

NCT07470203 | Not Yet Recruiting

• 1 other identifier: Pyro-HP Maintain
• Study Type: observational
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HER2-positive Breast Cancer

Keywords

pyrotinib; HER2-positive breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Overall survival (OS)

  Up to approximately 5 years

• Central nervous system (CNS) PFS

  Up to approximately 3 years

• 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

Interventions

Pyrotinib DRUG

240\~320mg given by mouth (orally) once daily every 21days

Trastuzuma DRUG

6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days

Pertuzumab DRUG

420mg given by IV every 21 days

Combination product: Trastuzumab + Pertuzumab DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

MeSH Terms

Interventions

pyrotinib; pertuzumab

Central Study Contacts

Guohong Song

CONTACT

010-8819 6406; songguohong918@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: March 13, 2026

Record last verified: 2026-03