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Treatment for advanced HR+/HER2- breast cancer and other solid tumors

An Open-label, Multi-center, Phase I/II Study of ECI830 as a Single Agent and in Combination With Ribociclib and Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2-negative Breast Cancer and Advanced Solid Tumors

Phase1; Phase2 Interventional Novartis · NCT06726148

This study is testing a new treatment called ECI830, alone and with other medications, to see if it helps people with advanced hormone receptor-positive breast cancer and certain other solid tumors.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment280 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Locations33 sites (Los Angeles, California and 32 other locations)
Trial IDNCT06726148 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of ECI830, both as a standalone treatment and in combination with ribociclib and fulvestrant, for patients with advanced hormone receptor-positive and HER2-negative breast cancer, as well as other solid tumors with CCNE1 amplification. The study is divided into two phases: the first phase focuses on determining the optimal dosage and safety profile of ECI830, while the second phase assesses its anti-tumor activity in combination with other therapies. The trial is open-label and multi-center, allowing for a diverse patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced HR+/HER2- breast cancer or solid tumors with CCNE1 amplification who have experienced disease progression after prior therapies.

Not a fit: Patients who have not progressed on prior hormone-based therapies or those with other types of breast cancer not meeting the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced breast cancer and other solid tumors, potentially improving outcomes.

How similar studies have performed: Other studies have shown promise with similar combination therapies in advanced breast cancer, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Age ≥ 18 years old.

Patients with one of the following indications:

Phase I:

HR+/HER2- aBC with disease progression on or following at least one line of hormone-based therapy in combination with a CDK4/6i and at least one additional line of systemic therapy for metastatic disease.

Histologically and/or cytologically confirmed diagnosis of locally advanced or metastatic cancer with a CCNE1 amplification. For dose expansion only: no more than 3 prior lines of therapy for advanced or metastatic disease.

Phase II:

HR+/HER2- aBC with disease progression on an aromatase inhibitor or tamoxifen in combination with a CDK4/6 inhibitor for unresectable/metastatic disease with no more than 2 lines of endocrine therapy.

Measurable disease as determined by RECIST v1.1.

BC only: If no measurable disease is present, then at least one predominantly lytic bone lesion must be present that can be accurately assessed at baseline and is suitable for repeated assessment.

Exclusion Criteria:

Previous treatment with a CDK2 inhibitor at any time.

Patients with inadequate bone marrow and/or organ functions with out-of-range laboratory values.

Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including MI, CABG, long QT syndrome, or risk factors for TdP.

Presence of symptomatic CNS metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.

For the combination treatment:

Patients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.

Patients who could not tolerate the prescribed dose of ribociclib during a previous course of treatment, requiring dose reduction or permanent discontinuation due to adverse events.

For patients with BC: Patient is concurrently using hormone replacement therapy.

WOCBP who are unwilling to use highly effective contraception methods, pregnant or nursing women.

Other protocol-defined inclusion/exclusion criteria may apply.

Where this trial is running

Los Angeles, California and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced HR+/HER2- Breast CancerAdvanced CCNE1-amplified Solid TumorsECI830RibociclibFulvestrantBreast cancerCCNE1 amplification
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.