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New drug combo for advanced breast cancer shows promise but trial halted early

NCT ID NCT05085002

Disease control Sponsor: EQRx, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study tested a new drug called lerociclib combined with standard hormone therapy in 100 people with advanced HR+/HER2- breast cancer. The goal was to see if the combination is safe and effective. However, the trial was terminated early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lerociclib (a targeted drug) combined with letrozole or fulvestrant (hormone therapies), plus goserelin for premenopausal participants
What this could lead to
If it worked, this could point toward a new treatment option for advanced breast cancer that is hormone receptor-positive and HER2-negative.
What could go wrong
The trial was terminated early, so results are limited. It was a small, single-arm phase 2 study, meaning no comparison group, and the drug may not prove effective or safe in larger trials.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

100 people

The number who actually took part.

Started

Dec 2021

Finished

Nov 2023

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 years and older

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: 1. Participant must be 18 or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent. 2. Histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer. 3. Advanced (locoregionally recurrent not amenable to curative therapy, eg, surgery and/or radiotherapy, or metastatic) breast cancer 4. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1. 5. Adequate bone marrow and organ function 6. Female that is not pregnant and agrees to contraceptive use that is consistent with local regulations regarding the methods of contraception to be used during the study 7. Males agree to use a highly effective method of contraception and will refrain from donating sperm from the first dose of any study intervention 8. Participant is capable of giving signed informed consent Exclusion Criteria: 1. Symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy per the Investigator's best judgment. 2. Peritoneal carcinomatosis. 3. Inflammatory breast cancer at screening. 4. Participant with central nervous system (CNS) involvement unless they are at least 4 weeks from prior therapy completion to starting the study treatment and have stable CNS tumor at the time of screening and not receiving steroids and/or enzyme inducing anti-epileptic medications for brain metastases. 5. Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality 6. Has a history of prolonged QT syndrome or Torsades de Pointes 7. Has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy) or any CDK4/6 inhibitor. 8. Has received prior treatment with fulvestrant. 9. Use of systemic estrogens 10. Participant is currently receiving any of the following substances and cannot be discontinued 14 days prior to start the treatment: * Known strong or moderate CYP3A inducers or strong inhibition of CYP3A * Substances that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5. 11. Echocardiogram done within the past 12 months with ejection fraction of ≤ 45% or documented history of congestive heart failure with reduced ejection fraction. 12. Evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or oral temperature \> 38°C at screening 13. Interstitial pneumonia or severe impairment of lung function

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Conditions

The condition(s) this trial relates to.

breast cancer hormone receptor-positive breast cancer

As listed by the trial registrant

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

Advanced breast cancer

Contacts and locations

Locations

  • ARENSIA Exploratory Medicine LLC

    Tbilisi, 0112, Georgia

  • CHA Libramont

    Libramont, 6800, Belgium

  • Cancer Care Associates of York, Inc.

    York, Pennsylvania, 17403, United States

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256, United States

  • Clinique Saint-Pierre asbl

    Ottignies, 1340, Belgium

  • IMSP Institutul Oncologic, Arsenia Exploratory Medicine

    Chisinau, MD-2025, Moldova

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"

    Meldola, 47014, Italy

  • LTD "Brothers"

    Batumi, 6010, Georgia

  • LTD "Health House"

    Tbilisi, 0144, Georgia

  • Ltd "Multiprofile Clinic Consilium Medulla "

    Tbilisi, 0186, Georgia

  • Ltd Israeli-Georgian Medical Research Clinic Helsicore

    Tbilisi, 0112, Georgia

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130, United States

  • Northwest Medical Specialties PLLC

    Tacoma, Washington, 98405, United States

  • Oregon Oncology Specialists

    Salem, Oregon, 97301, United States

  • PanAmerican Clinical Research Cuernavaca

    Cuernavaca, 66290, Mexico

  • PanAmerican Clinical Research Guadalajara

    Guadalajara, Jalisco, 44670, Mexico

  • PanAmerican Clinical Research, Queretaro

    Querétaro, 76100, Mexico

  • Tranquil Clinical Research

    Webster, Texas, 16969, United States

  • UZA

    Edegem, 2650, Belgium

  • Ziekenhuizen K.U.Leuven, Campus gasthuisberg

    Leuven, 3000, Belgium

  • vzw Verenigde Ziekenhuizen van Waas en Durme - VITAZ

    Sint-Niklaas, 9100, Belgium

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