A Study of Lerociclib in Participants With Advanced Breast Cancer

A Phase 2 Study to Evaluate the Safety and Efficacy of Lerociclib in Participants With Advanced Breast Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Advanced Breast Cancer
• Intervention / Treatment: Drug: Lerociclib + Letrozole or Fulvestrant

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • UZA
  • Leuven, Belgium, 3000
    • Ziekenhuizen K.U.Leuven, Campus gasthuisberg
  • Libramont, Belgium, 6800
    • CHA Libramont
  • Ottignies, Belgium, 1340
    • Clinique Saint-Pierre asbl
  • Sint-Niklaas, Belgium, 9100
    • vzw Verenigde Ziekenhuizen van Waas en Durme - VITAZ
• Georgia
  • Batumi, Georgia, 6010
    • LTD "Brothers"
  • Tbilisi, Georgia, 0112
    • Arensia Exploratory Medicine Llc
  • Tbilisi, Georgia, 0112
    • Ltd Israeli-Georgian Medical Research Clinic Helsicore
  • Tbilisi, Georgia, 0144
    • LTD "Health House"
  • Tbilisi, Georgia, 0186
    • Ltd "Multiprofile Clinic Consilium Medulla "
• Italy
  • Meldola, Italy, 47014
    • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"
• Mexico
  • Cuernavaca, Mexico, 66290
    • PanAmerican Clinical Research Cuernavaca
  • Querétaro, Mexico, 76100
    • PanAmerican Clinical Research, Querétaro
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44670
      • PanAmerican Clinical Research Guadalajara
• Moldova
  • Chisinau, Moldova, MD-2025
    • IMSP Institutul Oncologic, Arsenia Exploratory Medicine
• United States
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Cancer Specialists of North Florida
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Nebraska Cancer Specialists
  • Oregon
    • Salem, Oregon, United States, 97301
      • Oregon Oncology Specialists
  • Pennsylvania
    • York, Pennsylvania, United States, 17403
      • Cancer Care Associates of York, Inc.
  • Texas
    • Webster, Texas, United States, 16969
      • Tranquil Clinical Research
  • Washington
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lerociclib + letrozole or fulvestrant; Letrozole, administered orally once daily in tablet form at 2.5 mg. Fulvestrant, administered as an intramuscular injection, once every 2 weeks for the initial 3 doses and then once every 4 weeks (Q4W) thereafter, at 500 mg.	Drug: Lerociclib + Letrozole or Fulvestrant; All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.; Other Names: Goserelin acetate implant for pre- or perimenopausal female and male participants only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AEs and SAEs	The number and percentage of participants experiencing any TEAE and serious TEAE will be tabulated by line of therapy.	Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Characterize the Safety and Tolerability of Lerociclib in Combination With Endocrine Therapy in Participants With 1L and 2L Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor 2-negative (HER2-) Metastatic Breast Cancer (mBC).	Objective response rate, defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the Investigator.	Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
Probability of Progression-Free Survival (PFS)	A secondary endpoint for this study was to investigate the efficacy of lerociclib in combination with endocrine therapy in participants with 1L and 2L HR+/HER2- mBC by line of therapy. Probability of Progression-Free Survival (PFS) was measured. Per protocol, PFS was defined as the time from first dose of lerociclib until the date of documented progressive disease (PD) or death, according to RECIST v1.1 as assessed by the Investigator.	The timeframe for data collection was up to 18 months.
Description of Kaplan-Meier Estimates Analysis for Progression-free Survival Event Analysis	Progression-free survival (PFS), defined as the time from first dose of lerociclib until the date of documented progressive disease (PD) or death, according to RECIST v1.1 as assessed by the Investigator.	Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.

Collaborators and Investigators

• Sponsor: EQRx, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Actual): November 29, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Polycyclic Compounds; Inorganic Chemicals; Steroids; Fused-Ring Compounds; Elements; Metals; Nitriles; Metals, Heavy; Estradiol; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Triazoles; Gonadotropin-Releasing Hormone; Letrozole; Fulvestrant; Goserelin; Lead
• Other Study ID Numbers: EQ132-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No