IEV407 alone or with hormone therapy for advanced HR+/HER2- breast cancer
Tests IEV407, alone or with fulvestrant or letrozole, in adults with advanced breast cancer.
Key facts
- Who runs it
- Novartis Pharmaceuticals
- Where
- Singapore, SingaporeSee the siteAlso in 8 other countries, 11 sites
- Trial code
- Registry title
- Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 194 people, planned
- Started
- 28 May 2026
- Expected to end
- 8 Jun 2032
- Type of study
- Interventional, 5 groups
- Treatments tested
- IEV407
- Fulvestrant
- Letrozole
- Record updated
- 3 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced breast cancer that is hormone receptor positive and HER2-negative, whose cancer has worsened or who could not tolerate earlier treatments.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Advanced (unresectable or metastatic) HR+/HER2- breast cancer. The cancer progressed on, or after, or the person could not tolerate, endocrine-based therapy together with a CDK4/6 inhibitor.
- Earlier treatment
- Dose escalation: at least one line of endocrine-based therapy with a CDK4/6 inhibitor and at least one more line of systemic therapy, and no standard therapy available in the investigator's judgement. Dose expansion with fulvestrant: no more than two prior lines of endocrine-based therapy in the unresectable/metastatic setting; prior chemotherapy or antibody-drug conjugate therapy in that setting is not allowed.
- Biomarker or test result
- Hormone receptor positive (HR+) and HER2-negative breast cancer.
Main reasons for not taking part
- Poor bone marrow or organ function on lab tests
- Impaired heart function or significant heart disease
- Taking hormone replacement therapy at the same time
- Pregnant or nursing women, or women who could have children and will not use highly effective contraception
- For the fulvestrant or letrozole combination: symptomatic visceral disease or disease burden that rules out endocrine-based therapy
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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 least 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's 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
Who cannot take part
- Concurrent use of hormone replacement therapy
- Impaired cardiac function or clinically significant cardiac disease
- 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; Other protocol-defined inclusion/exclusion criteria may apply
- Patients with inadequate bone marrow and/or organ functions with out-of-range laboratory values
- Women of childbearing potential who are unwilling to use highly effective contraception methods, pregnant or nursing women
Where in Singapore
Also in 8 other countries, 11 sites
- SingaporeHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
About the trial
What the trial wants to find out
The purpose of this study is to evaluate the safety, tolerability and preliminary activity of IEV407 as a single agent and in combination with endocrine therapy (fulvestrant or letrozole) in patients with advanced hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-negative) breast cancer.
The 5 groups in the trial
- Dose escalation: IEV407 single agentTreatment being tested
IEV407 single agent
Treatment: IEV407
- Dose escalation: IEV407 + fulvestrantTreatment being tested
IEV407 in combination with fulvestrant
Treatment: IEV407 and Fulvestrant
- Dose escalation: IEV407 + letrozoleTreatment being tested
IEV407 in combination with letrozole
Treatment: IEV407 and Letrozole
- Dose expansion, recommended dose (RD)-1: IEV407 + fulvestrantTreatment being tested
IEV407 in combination with fulvestrant
Treatment: IEV407 and Fulvestrant
- Dose expansion, RD-2 (optional dose optimization): IEV407 + fulvestrantTreatment being tested
IEV407 in combination with fulvestrant
Treatment: IEV407 and Fulvestrant
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- An Open-label, Multi-center, Phase I/Ib Study of IEV407 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer
- Plain-language title
- IEV407 alone or with hormone therapy for advanced HR+/HER2- breast cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 3 November 2026