194 Participants NeededMy employer runs this trial

IEV407 for Breast Cancer

Recruiting at 5 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Novartis Pharmaceuticals
Must be taking: Endocrine therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and initial effectiveness of a new drug, IEV407, for advanced breast cancer that is hormone receptor-positive (HR+) and HER2-negative. Researchers are exploring the efficacy of IEV407 both alone and in combination with other treatments, such as fulvestrant (a hormone therapy) or letrozole (an aromatase inhibitor). The trial seeks participants whose breast cancer has progressed despite previous therapy and who have tried at least one other treatment. Participants should not have received more than two types of hormone-based treatments for their cancer in its advanced stage. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot use hormone replacement therapy while participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that IEV407 remains in the early testing stages, so detailed safety information is not yet available. However, the trial is closely monitored to ensure patient safety.

When combined with fulvestrant, a drug already used for breast cancer, studies indicate that fulvestrant is generally safe and effective. This combination is under study for its potential benefits in breast cancer treatment, but like all new treatments, it requires thorough testing to confirm safety.

Letrozole, another approved breast cancer drug, is known to be effective and generally well-tolerated. Studies have shown it works well for advanced breast cancer, but the safety of combining it with IEV407 is still under investigation.

Overall, while limited safety data exists for IEV407, the established use of fulvestrant and letrozole in breast cancer treatment offers some reassurance about the safety of these combinations.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about IEV407 for breast cancer because it introduces a potentially new mechanism of action unlike traditional treatments. While most current therapies, like chemotherapy and hormone therapies such as fulvestrant and letrozole, target cancer cells' growth pathways or hormone receptors, IEV407 may offer a novel approach by interacting differently at the cellular level. Additionally, the trial includes exploring IEV407 both as a single agent and in combination with existing treatments like fulvestrant and letrozole, aiming to enhance effectiveness and potentially overcome resistance seen in standard therapies. This fresh approach might provide new hope for patients who have limited options.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Research has shown that IEV407 could be a promising treatment for advanced hormone receptor positive (HR+), HER2-negative breast cancer. In this trial, participants may receive IEV407 as a single agent. Early studies suggest it aims to shrink tumors and improve patient outcomes, although more data is still being gathered. Other participants will receive IEV407 with fulvestrant, a well-known breast cancer treatment, which might enhance effectiveness. Fulvestrant alone has shown an average time of 9 months before cancer worsens. Additionally, some participants will receive IEV407 with letrozole, another breast cancer treatment, which may also be beneficial. Letrozole alone has proven very effective and well-tolerated by patients. These combinations aim to slow cancer progression and improve survival rates.12678

Are You a Good Fit for This Trial?

This trial is for adults with advanced HR+/HER2- breast cancer whose disease has worsened after at least one hormone therapy plus a CDK4/6 inhibitor and another systemic treatment, and who have no standard treatments left. Some groups must not have had more than two prior hormone therapies or certain chemotherapies.

Inclusion Criteria

My HR+/HER2- breast cancer got worse after endocrine and other treatments, and no standard therapy is left for me.
I have HR+/HER2- advanced breast cancer that got worse after or during hormone therapy with a CDK4/6 inhibitor, and I have had no more than two hormone therapies for advanced cancer. I have not had chemotherapy or antibody-drug conjugates for advanced cancer.
I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Evaluation of IEV407 as a single agent and in combination with endocrine therapy to establish recommended dose ranges

28 days
Multiple visits for dose escalation and monitoring

Dose Expansion

Evaluation of IEV407 in combination with fulvestrant at recommended dose levels

Up to approximately 2 years
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Fulvestrant
  • IEV407
  • Letrozole

Trial Overview

The study tests a new drug called IEV407 alone or combined with either fulvestrant or letrozole (both are hormone therapies) to see how safe it is and how well it works in people with this type of breast cancer.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Group I: Dose expansion, recommended dose (RD)-1: IEV407 + fulvestrantExperimental Treatment2 Interventions
Group II: Dose expansion, RD-2 (optional dose optimization): IEV407 + fulvestrantExperimental Treatment2 Interventions
Group III: Dose escalation: IEV407 single agentExperimental Treatment1 Intervention
Group IV: Dose escalation: IEV407 + letrozoleExperimental Treatment2 Interventions
Group V: Dose escalation: IEV407 + fulvestrantExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

Study of IEV407 as Single Agent or in Combination ...

The purpose of this study is to evaluate the safety, tolerability and preliminary activity of IEV407 as a single agent. Efficacy will be based ...

Study of IEV407 as Single Agent or in Combination ...

The purpose of this study is to evaluate the safety, tolerability and preliminary activity of IEV407 as a single agent and in combination ...

and triple negative metastatic breast cancer - PMC - NIH

Outcomes Among patients in this study with HR+/HER2- mBC, median rwOS was 32.3 months (95% The median rwPFS was 8.6. Tumor response was highly ...

Phase 3 Study Confirms Long-Term Efficacy of Radiation in ...

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Overall, tumor shrinkage of ≥30% was observed in 16 (9.5%) patients. “Despite the modest overall response rate in unselected metastatic breast cancer patients, ...

ECI830 + Ribociclib + Fulvestrant for Breast Cancer

Final safety results are not yet available, but the treatment's early testing phase involves close safety monitoring.

Patient-reported outcomes in breast cancer FDA drug labels ...

Our objectives were to compare PRO data reported in FDA labeling versus FDA medical review documents for breast cancer drugs approved in the US between 2000 ...

Rapid Fire 7 - San Antonio Breast Cancer Symposium

Hyperglycemia incidence was 9.2% and 11.5%, respectively, QOL outcomes, and expanded safety data will be presented.