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New combo therapy aims to control advanced breast cancer

NCT ID NCT06726148

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study tests a new drug called ECI830, alone or with other cancer drugs (ribociclib and fulvestrant), in people with advanced hormone receptor-positive, HER2-negative breast cancer or certain solid tumors. The goal is to find safe doses and see if the combination can slow cancer growth. About 280 adults will take part across multiple centers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 280 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. Patients with ES-SCLC and disease progression on or after standard of care (SoC). For dose expansion only: no more than 2 prior lines of therapy for advanced or metastatic disease are allowed. 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.

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Conditions

The condition(s) this trial relates to.

breast neoplasm hormone receptor-positive breast cancer small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced CCNE1-amplified solid tumors Advanced HR+/HER2- breast cancer Extensive-stage small-cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    33 sites in 16 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Florida Cancer Specialists

    RECRUITING

    Fort Myers, Florida, 33901, United States

  • Fred Hutch Cancer Research

    RECRUITING

    Seattle, Washington, 98109, United States

  • MD Anderson Cancer Center Uni of Te

    RECRUITING

    Houston, Texas, 77030, United States

  • Memorial Sloan Kettering

    RECRUITING

    New York, New York, 10017, United States

  • Novartis Investigative Site

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Novartis Investigative Site

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Novartis Investigative Site

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Novartis Investigative Site

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Novartis Investigative Site

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Novartis Investigative Site

    RECRUITING

    Xian, Shanxi, 710061, China

  • Novartis Investigative Site

    RECRUITING

    Brno, 656 53, Czechia

  • Novartis Investigative Site

    RECRUITING

    Copenhagen, 2100, Denmark

  • Novartis Investigative Site

    RECRUITING

    Odense C, 5000, Denmark

  • Novartis Investigative Site

    RECRUITING

    Bordeaux, 33076, France

  • Novartis Investigative Site

    RECRUITING

    Saint-Herblain, 44805, France

  • Novartis Investigative Site

    RECRUITING

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Novartis Investigative Site

    RECRUITING

    Heidelberg, 69120, Germany

  • Novartis Investigative Site

    RECRUITING

    Ulm, 89081, Germany

  • Novartis Investigative Site

    RECRUITING

    Haifa, 3109601, Israel

  • Novartis Investigative Site

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    RECRUITING

    Milan, MI, 20141, Italy

  • Novartis Investigative Site

    RECRUITING

    Modena, MO, 41124, Italy

  • Novartis Investigative Site

    RECRUITING

    Chuo Ku, Tokyo, 1040045, Japan

  • Novartis Investigative Site

    RECRUITING

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    RECRUITING

    Seoul, Seoul, 03080, South Korea

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    RECRUITING

    Tainan, 704, Taiwan

  • Novartis Investigative Site

    RECRUITING

    London, Oxford, OX3 7LE, United Kingdom

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • University of California LA

    RECRUITING

    Los Angeles, California, 90095, United States

  • WA Uni School Of Med

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.