A Study of Lerociclib in Participants With Advanced Breast Cancer

  • STATUS
    Recruiting
  • End date
    May 15, 2026
  • participants needed
    100
  • sponsor
    EQRx, Inc.
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Updated on 15 June 2022
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Summary

This is a multicenter, single-arm, open-label study to evaluate the safety and efficacy of lerociclib in combination with standard endocrine therapy in female or male participants with HR+/HER2- MBC. The study population will consist of either newly diagnosed, treatment naïve participants with HR+/HER2- MBC (1L population) and participants with HR+/HER2- MBC who have already progressed on first line endocrine therapy such as tamoxifen, anastrozole, or letrozole (2L population). All premenopausal or perimenopausal female participants, and all male participants, must be receiving goserelin for at least 28 days prior to entering the study and will remain on goserelin throughout the study, in accordance with the prescribing information and according to the study site's standard practice.

Details
Condition Advanced Breast Cancer
Treatment Lerociclib + Letrozole or Fulvestrant
Clinical Study IdentifierNCT05085002
SponsorEQRx, Inc.
Last Modified on15 June 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
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
Advanced (locoregionally recurrent not amenable to curative therapy, eg, surgery and/or radiotherapy, or metastatic) breast cancer
Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
Adequate bone marrow and organ function
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
Males agree to use a highly effective method of contraception and will refrain from donating sperm from the first dose of any study intervention
Participant is capable of giving signed informed consent

Exclusion Criteria

Symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy per the Investigator's best judgment
Peritoneal carcinomatosis
Inflammatory breast cancer at screening
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
Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
Has a history of prolonged QT syndrome or Torsades de Pointes
Has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy) or any CDK4/6 inhibitor
Has received prior treatment with fulvestrant
Use of systemic estrogens
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
Echocardiogram done within the past 12 months with ejection fraction of ≤ 45% or
documented history of congestive heart failure with reduced ejection fraction
Evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or oral temperature > 38°C at screening
Interstitial pneumonia or severe impairment of lung function
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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