Clinical trial NCT05085002: A Study of Lerociclib in Participants With Advanced Breast Cancer
Official title: A Phase 2 Study to Evaluate the Safety and Efficacy of Lerociclib in Participants With Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Advanced Breast Cancer
Lead sponsor: EQRx International, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of AEs and SAEs
timeFrame: Up to 4.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Salem
country: United States
facility: Oregon Oncology Specialists
state: Oregon
city: York
country: United States
facility: Cancer Care Associates of York, Inc.
state: Pennsylvania
city: Webster
country: United States
facility: Tranquil Clinical Research
state: Texas
city: Tacoma
country: United States
facility: Northwest Medical Specialties PLLC
state: Washington
city: Edegem
country: Belgium
facility: UZA
city: Leuven
country: Belgium
facility: Ziekenhuizen K.U.Leuven, Campus gasthuisberg
city: Libramont
country: Belgium
facility: CHA Libramont
city: Ottignies
country: Belgium
facility: Clinique Saint-Pierre asbl
city: Sint-Niklaas
country: Belgium
facility: vzw Verenigde Ziekenhuizen van Waas en Durme - VITAZ
city: Batumi
country: Georgia
facility: LTD "Brothers"
city: Tbilisi
country: Georgia
facility: ARENSIA Exploratory Medicine LLC
city: Tbilisi
country: Georgia
facility: Ltd Israeli-Georgian Medical Research Clinic Helsicore
city: Tbilisi
country: Georgia
facility: LTD "Health House"
city: Tbilisi
country: Georgia
facility: Ltd "Multiprofile Clinic Consilium Medulla "
city: Meldola
country: Italy
facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"
city: Guadalajara
country: Mexico
facility: PanAmerican Clinical Research Guadalajara
state: Jalisco
city: Cuernavaca
country: Mexico
facility: PanAmerican Clinical Research Cuernavaca
city: Querétaro
country: Mexico
facility: PanAmerican Clinical Research, Queretaro
city: Chisinau
country: Moldova, Republic of
facility: IMSP Institutul Oncologic, Arsenia Exploratory Medicine
Study officials:
References: