Advanced HR+/HER2- Breast Cancer
Conditions
Interventions
Experimental: IEV407 Single Agent
Experimental: IEV407 in combination with fulvestrant
Experimental: IEV407 in combination with letrozole
Sponsors
Moizumi Sanae
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age >= 18 years old - Patients with one of the following indications: -Dose escalation (IEV407 single agent and in combination with fulvestrant or letrozole):HR+/HER2- aBC with disease progression on or following, or have been intolerant to, at leaset one line of endocrine-based therapy in combination with a CDK4/6 inhibitor and at least one additional line of systemic therapy in the unresectable/metastatic setting and not be a candidate for any available standard therapy, in the investigator judgement. -Dose expansion of IEV407 in combination with fulvestrant: HR+/HER2- aBC with disease progression on or following, or have been intolerant to, endocrine-based therapy in combination with a CDK4/6 inhibitor. They must not have received more than two prior lines of endocrine-based therapy in the unresectable/metastatic setting. Prior cytotoxic chemotherapy and/or antibody-drug conjugate therapies in the unresectable/metastatic setting are not allowed.
Exclusion criteria
Exclusion criteria: - Patients with inadequate bone marrow and/or organ functions with out-of-range laboratory values. - Impaired cardiac function or clinically significant cardiac disease. - Concurrent use of hormone replacement therapy. - Women of childbearing potential who are unwilling to use highly effective contraception methods, pregnant or nursing women. - For the combination treatment of IEV407 with fulvestrant or letrozole: Patients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of dose-limiting toxicities (DLTs) Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) Frequency of dose interruptions, reductions and discontinuations Dose intensity | — |
Countries
Canada, Czech Republic, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Korea, Nethherlands, Poland, Portugal, Singapore, Spain, Taiwan, UK, United States
Contacts
Public ContactSanae Moizumi
Novartis Pharma. K.K.
Outcome results
None listed