A Study of Lerociclib in Participants With Advanced Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05085002|
Recruitment Status : Recruiting
First Posted : October 20, 2021
Last Update Posted : February 15, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Advanced Breast Cancer||Drug: Lerociclib + Letrozole or Fulvestrant||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study to Evaluate the Safety and Efficacy of Lerociclib in Participants With Advanced Breast Cancer|
|Actual Study Start Date :||December 21, 2021|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||May 2026|
|Lerociclib + letrozole or fulvestrant||
Drug: Lerociclib + Letrozole or Fulvestrant
All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
- Incidence of AEs and SAEs [ Time Frame: Up to 4.5 years ]The number and percentage of participants experiencing any TEAE and serious TEAE will be tabulated by line of therapy.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Gender Based Eligibility:||Yes|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05085002
|Responsible Party:||EQRx, Inc.|
|Other Study ID Numbers:||
|First Posted:||October 20, 2021 Key Record Dates|
|Last Update Posted:||February 15, 2023|
|Last Verified:||February 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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