A Study of Lerociclib in Participants With Advanced Breast Cancer

Advanced Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05085002
• Other study ID #: EQ132-201
• Status: Terminated
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

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