ECI830 + Ribociclib + Fulvestrant for Breast Cancer

Recruiting at 28 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Novartis Pharmaceuticals

Must be taking: Ribociclib, Fulvestrant

Must not be taking: CDK2 inhibitors

Disqualifiers: Heart disease, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, ECI830, for advanced breast cancer that is hormone receptor-positive and HER2-negative. Researchers aim to determine if ECI830 is safe on its own and how it interacts with two other drugs, ribociclib and fulvestrant, to combat cancer. They are also identifying the appropriate dose for future studies. This trial may suit individuals whose breast cancer has progressed despite previous hormone and CDK4/6 inhibitor treatments. 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 treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications. However, if you are using hormone replacement therapy, you may not be eligible to participate.

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

Research is ongoing to determine the safety and tolerability of ECI830, both alone and in combination with ribociclib and fulvestrant. Final safety results are not yet available, but the treatment's early testing phase involves close safety monitoring.

Past studies have shown that ribociclib and fulvestrant are generally well-tolerated. Some individuals may experience side effects like nausea or tiredness, but these are often manageable. Ribociclib, when used with fulvestrant in other studies, has shown a significant survival benefit without unexpected safety issues.

In summary, while the safety of ECI830 is still under investigation, ribociclib and fulvestrant have a proven track record of general safety when used together. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ECI830 because it offers a novel approach to treating breast cancer. Unlike standard treatments, which often target hormonal pathways or rely on chemotherapy, ECI830 works through a unique mechanism that may enhance the effectiveness of existing drugs like ribociclib and fulvestrant. This study is testing ECI830 both as a single agent and in combination with these established therapies, which could potentially lead to improved outcomes for patients. By exploring these combinations, there is hope to discover more effective treatment regimens with fewer side effects, offering new hope for those with breast cancer.

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

Research has shown that combining ribociclib and fulvestrant effectively treats a type of advanced breast cancer known as HR+/HER2-. Studies have found that this combination can lower the risk of death by 28% and significantly increase overall survival. In this trial, some participants will receive ribociclib with fulvestrant, which consistently leads to better results compared to fulvestrant alone.

ECI830 is a newer treatment, and its effects are still under investigation. In this trial, ECI830 is tested both by itself and in combination with ribociclib and fulvestrant. The goal is for ECI830 to enhance current treatments by targeting specific cancer pathways, but more research is needed to confirm this. Early results suggest it might help shrink tumors when used with these other drugs. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with advanced hormone receptor-positive, HER2-negative breast cancer who've seen their disease progress after treatment with aromatase inhibitors or tamoxifen and a CDK4/6 inhibitor. They should have measurable disease or at least one assessable lytic bone lesion if no measurable disease is present. Participants can't have had more than two lines of endocrine therapy or three prior therapies for metastatic disease.

Inclusion Criteria

My breast cancer is HR+/HER2- and has worsened despite specific hormone treatments.

My cancer can be measured using standard criteria.

My breast cancer is HR+/HER2- and has worsened despite hormone therapy and other treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization/recommended dose for future studies.

28 days

Multiple visits for dose escalation and monitoring

Phase II Treatment

Assess the anti-tumor activity of ECI830 in combination with ribociclib and fulvestrant in patients with HR+/HER2- advanced breast cancer.

6 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• ECI830
• Fulvestrant
• Ribociclib

Trial Overview The study has two parts: Phase I tests the safety and best dose of ECI830 alone and combined with ribociclib and fulvestrant. Phase II evaluates how well ECI830 works in combination with these drugs to treat HR+/HER2- advanced breast cancer by measuring its effect on tumor size.

How Is the Trial Designed?

Group I: Ribociclib in combination with fulvestrant (Arm C) Experimental Treatment 2 Interventions

Phase II

Group II: ECI830 in combination with ribociclib and fulvestrant (Arm F) Experimental Treatment 3 Interventions

Phase II

Group III: ECI830 in combination with ribociclib and fulvestrant (Arm E) Experimental Treatment 3 Interventions

Phase II

Group IV: ECI830 in combination with fulvestrant (Arm D) Experimental Treatment 2 Interventions

Phase II

Group V: ECI830 Single Agent (Arm A) Experimental Treatment 1 Intervention

Phase I

Group VI: Dose Escalation Combination ECI830 + ribociclib + fulvestrant (Arm B) Experimental Treatment 3 Interventions

Phase I

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

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06726148

NCT06726148 | Study of ECI830 Single Agent or in ... This is a first-in-human, open-label, phase I/II, multi-center study consisting of an ECI830 single agent treatment arm in patients with advanced HR+/HER2- ...

2. novartis.com novartis.com/clinicaltrials/study/nct06726148

Study of ECI830 Single Agent or in Combination in Patients ... This is a first-in-human, open-label, phase I/II, multi-center study consisting of an ECI830 single agent treatment arm in patients with advanced HR+/HER2- ...

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/558297

Study of ECI830 Single Agent or in Combination in Patients ... Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors · Overview · Trial locations.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0305737225001021

Overcoming Resistance to CDK4/6 inhibitors in Hormone ... Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) in combination with endocrine therapy (ET) improve outcomes patients affected by metastatic and early-stage ...

5. withpower.com withpower.com/trial/phase-2-advanced-hrher2--breast-cancer-2-2025-9365c

ECI830 + Ribociclib + Fulvestrant for Breast Cancer Phase II evaluates how well ECI830 works in combination with these drugs to treat HR+/HER2- advanced breast cancer by measuring its effect on tumor size.

6. breastcancertrials.org breastcancertrials.org/bct_nation/mts/mtsResult.seam?zip=94107&searchTerm1=NCT06726148

MTS Trials Purpose: To study the safety, effects (good and bad), and anti-cancer activity of ECI830, an experimental; CDK2 inhibitor, with ribociclib (Kisqali®) CDK4/6 ...

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/558297

Study of ECI830 Single Agent or in Combination in Patients ... Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant.