DRUG
Lerociclib + Letrozole or Fulvestrant
All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
Status
Terminated
Phase
Phase 2
Enrollment
100
Locations
21
Results
Posted
Publications
0
Study 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.
Interventions
DRUG
All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
Timeline
First posted
Oct 20, 2021
Study start
Dec 21, 2021
Primary completion
Nov 29, 2023
Study completion
Nov 29, 2023
Results posted
May 14, 2026
Registry updated
May 14, 2026
Outcomes
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.
The number and percentage of participants experiencing any TEAE and serious TEAE will be tabulated by line of therapy.
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.
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.
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.
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.
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 locations
Belgium · Georgia · Italy · Mexico · Moldova · United States. Showing up to 24 locations stored in the fast local snapshot.
Cancer Specialists of North Florida
Jacksonville, Florida, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Oregon Oncology Specialists
Salem, Oregon, United States
Cancer Care Associates of York, Inc.
York, Pennsylvania, United States
Tranquil Clinical Research
Webster, Texas, United States
Northwest Medical Specialties PLLC
Tacoma, Washington, United States
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, Belgium
LTD "Brothers"
Batumi, Georgia
ARENSIA Exploratory Medicine LLC
Tbilisi, Georgia
Ltd Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, Georgia
LTD "Health House"
Tbilisi, Georgia
Ltd "Multiprofile Clinic Consilium Medulla "
Tbilisi, Georgia
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"
Meldola, Italy
PanAmerican Clinical Research Guadalajara
Guadalajara, Jalisco, Mexico
PanAmerican Clinical Research Cuernavaca
Cuernavaca, Mexico
PanAmerican Clinical Research, Queretaro
Querétaro, Mexico
IMSP Institutul Oncologic, Arsenia Exploratory Medicine
Chisinau, Moldova
Publications
No PMID-linked publications were present in this registry snapshot.
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