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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05085002
Other study ID # EQ132-201
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date December 21, 2021
Est. completion date November 29, 2023

Study information

Verified date December 2023
Source EQRx International, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 100
Est. completion date November 29, 2023
Est. primary completion date November 29, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lerociclib + Letrozole or Fulvestrant
All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.

Locations

Country Name City State
Belgium UZA Edegem
Belgium Ziekenhuizen K.U.Leuven, Campus gasthuisberg Leuven
Belgium CHA Libramont Libramont
Belgium Clinique Saint-Pierre asbl Ottignies
Belgium vzw Verenigde Ziekenhuizen van Waas en Durme - VITAZ Sint-Niklaas
Georgia LTD "Brothers" Batumi
Georgia ARENSIA Exploratory Medicine LLC Tbilisi
Georgia LTD "Health House" Tbilisi
Georgia Ltd "Multiprofile Clinic Consilium Medulla " Tbilisi
Georgia Ltd Israeli-Georgian Medical Research Clinic Helsicore Tbilisi
Italy Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" Meldola
Mexico PanAmerican Clinical Research Cuernavaca Cuernavaca
Mexico PanAmerican Clinical Research Guadalajara Guadalajara Jalisco
Mexico PanAmerican Clinical Research, Queretaro Querétaro
Moldova, Republic of IMSP Institutul Oncologic, Arsenia Exploratory Medicine Chisinau
United States Cancer Specialists of North Florida Jacksonville Florida
United States Nebraska Cancer Specialists Omaha Nebraska
United States Oregon Oncology Specialists Salem Oregon
United States Northwest Medical Specialties PLLC Tacoma Washington
United States Tranquil Clinical Research Webster Texas
United States Cancer Care Associates of York, Inc. York Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
EQRx, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Georgia,  Italy,  Mexico,  Moldova, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of AEs and SAEs The number and percentage of participants experiencing any TEAE and serious TEAE will be tabulated by line of therapy. Up to 4.5 years
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