metastatic HER2+ breast cancer
Conditions
Interventions
Subjects will be randomized in a 1:1 ratio to receive 1 of the following study treatments, either:
1. Control arm: Placebo tablets PO BID plus trastuzumab and pertuzumab every 21 days
2. Experimental
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Centrally confirmed HER2+ breast carcinoma per 2018 American Society of Clinical Oncologists (ASCO) College of American Pathologists (CAP) guidelines. -Have unresectable locally advanced or metastatic disease. - If recurrent (after [neo]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab or pertuzumab received in the early breast cancer setting to the diagnosis of advanced HER2+ disease.. -Have received 4-8 cycles (21 day cycles) of previous treatment with trastuzumab, pertuzumab, and taxane as first-line therapy for advanced HER2+ breast cancer with no evidence of disease progression -Known hormone receptor status (per local guidelines; may be hormone receptor positive [HR+] or negative [HR-]) -Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 -CNS Inclusion - Based on screening contrast brain magnetic resonance imaging (MRI), participants may have any of the following: - No evidence of brain metastases - Untreated brain metastases which are asymptomatic and, if identified on prior brain imaging, without evidence of progression since starting first-line induction therapy with trastuzumab, pertuzumab, and taxane - Previously treated brain metastases which are asymptomatic * Brain metastases previously treated with local therapy must not have progressed since treatment"
Exclusion criteria
Exclusion criteria: -Prior treatment with any anti-HER2 and/or anti-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib (except neratinib if given in extended adjuvant setting and >= 12 months have elapsed since last neratinib dose prior to start of study drug) -Unable to undergo contrast MRI of the brain -CNS Exclusion - Based on screening brain MRI and clinical assessment -Symptomatic brain metastasis -Progression of brain metastases since starting first line trastuzumab, pertuzumab, and taxane -Ongoing use of systemic corticosteroids at a total daily dose of >2 mg of dexamethasone (or equivalent) -Any untreated brain lesion in an anatomic site which may pose risk to participant -Known or suspected leptomeningeal disease (LMD) -Poorly controlled (>1/week) seizures, or other persistent neurologic symptoms"
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Finland, France, Germany, Greece, Italy, Japan, Korea, Netherlands, Poland, Portugal, Spain, Switzerland, Taiwan, United Kingdom, USA
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed