Trial · Interventional

TerminatedPhase 2Results postedRegistry data

A Study of Lerociclib in Participants With Advanced Breast Cancer

NCTNCT05085002Other idEQ132-201

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: The study is being closed based on corporate changes at EQRx and is not related to any efficacy or safety issues with lerociclib.

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 100 participants (actual)
Sponsor: EQRx, Inc. · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 6 countries
United States, Belgium, Georgia, Italy, Mexico, Moldova
Start: 21 Dec 2021
Primary completion: 29 Nov 2023
Completion: 29 Nov 2023
First posted: 20 Oct 2021
Last update posted: 14 May 2026
Conditions: Advanced Breast Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2021202220232024

Ph 2
A Study of Lerociclib in Participants With Advanced Breast Cancer
NCT05085002
21 Dec 2021 to 29 Nov 2023
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Lerociclib + Letrozole or FulvestrantDrug

Arms1

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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Incidence of AEs and SAEs
Time frame · 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.
Registry description
The number and percentage of participants experiencing any TEAE and serious TEAE will be tabulated by line of therapy.

Secondary outcomes(3)

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).
Time frame · 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.
Registry description
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.
Probability of Progression-Free Survival (PFS)
Time frame · The timeframe for data collection was up to 18 months.
Registry description
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.
Description of Kaplan-Meier Estimates Analysis for Progression-free Survival Event Analysis
Time frame · 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.
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 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.

Incidence of AEs and SAEs

Group	Value (participants)
Lerociclib + Letrozole or Fulvestrant 1L	11
Lerociclib + Letrozole or Fulvestrant 2L	12

Secondary and other outcome results(3)

Secondary outcomeNumber· 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.

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).

Group	Value (participants)
Lerociclib + Letrozole or Fulvestrant 1L	0
Lerociclib + Letrozole or Fulvestrant 2L	0

Secondary outcomeNumber· The timeframe for data collection was up to 18 months.

Probability of Progression-Free Survival (PFS)

Group	Value (probability)
Lerociclib + Letrozole or Fulvestrant 1L	0.82
Lerociclib + Letrozole or Fulvestrant 2L	0.70

Description of Kaplan-Meier Estimates Analysis for Progression-free Survival Event Analysis

Group	Value (number of participants)
Lerociclib + Letrozole or Fulvestrant 1L	4
Lerociclib + Letrozole or Fulvestrant 2L	8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Lerociclib + Letrozole or Fulvestrant 1LLetrozole, 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. Lerociclib + Letrozole or Fulvestrant: All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.	5 / 54	4 / 54	23 / 54
Lerociclib + Letrozole or Fulvestrant 2LLetrozole, 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. Lerociclib + Letrozole or Fulvestrant: All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.	3 / 46	2 / 46	18 / 46

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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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