HER2-positive Breast Cancer
Conditions
Keywords
pyrotinib, HER2-positive breast cancer
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.
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.
Interventions
DRUGPyrotinib
240\~320mg given by mouth (orally) once daily every 21days
DRUGTrastuzuma
6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
DRUGPertuzumab
420mg given by IV every 21 days
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.
Sponsors
Peking University Cancer Hospital & Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to approximately 5 years | The time from the date the patient begins treatment to death from any cause. |
| Central nervous system (CNS) PFS | Up to approximately 3 years | The time from the patient begins treatment to investigator assessed disease progression in brain (RECIST v1.1), or death from any cause |
| 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 | — |
Contacts
CONTACTGuohong Song
Outcome results
None listed