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A Study of Lerociclib in Participants With Advanced Breast Cancer

Primary Purpose

Advanced Breast Cancer

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lerociclib + Letrozole or Fulvestrant
Sponsored by
EQRx, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Specialists of North Florida
  • Nebraska Cancer Specialists
  • Oregon Oncology Specialists
  • Cancer Care Associates of York, Inc.
  • Tranquil Clinical Research
  • Northwest Medical Specialties PLLC
  • UZA
  • Ziekenhuizen K.U.Leuven, Campus gasthuisberg
  • CHA Libramont
  • Clinique Saint-Pierre asbl
  • vzw Verenigde Ziekenhuizen van Waas en Durme - VITAZ
  • LTD "Brothers"
  • ARENSIA Exploratory Medicine LLC
  • Ltd Israeli-Georgian Medical Research Clinic Helsicore
  • LTD "Health House"
  • Ltd "Multiprofile Clinic Consilium Medulla "
  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"
  • PanAmerican Clinical Research Guadalajara
  • PanAmerican Clinical Research Cuernavaca
  • PanAmerican Clinical Research, Queretaro
  • IMSP Institutul Oncologic, Arsenia Exploratory Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Lerociclib + letrozole or fulvestrant

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 7, 2021
Last Updated
October 6, 2023
Sponsor
EQRx, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05085002
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 21, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EQRx, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lerociclib + letrozole or fulvestrant
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Lerociclib + Letrozole or Fulvestrant
Intervention Description
All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
Primary Outcome Measure Information:
Title
Incidence of AEs and SAEs
Description
The number and percentage of participants experiencing any TEAE and serious TEAE will be tabulated by line of therapy.
Time Frame
Up to 4.5 years

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Advanced (locoregionally recurrent not amenable to curative therapy, eg, surgery and/or radiotherapy, or metastatic) breast cancer Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1. Adequate bone marrow and organ function 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 Males agree to use a highly effective method of contraception and will refrain from donating sperm from the first dose of any study intervention Participant is capable of giving signed informed consent Exclusion Criteria: Symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy per the Investigator's best judgment. Peritoneal carcinomatosis. Inflammatory breast cancer at screening. 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. Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality Has a history of prolonged QT syndrome or Torsades de Pointes Has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy) or any CDK4/6 inhibitor. Has received prior treatment with fulvestrant. Use of systemic estrogens 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. Echocardiogram done within the past 12 months with ejection fraction of ≤ 45% or documented history of congestive heart failure with reduced ejection fraction. Evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or oral temperature > 38°C at screening Interstitial pneumonia or severe impairment of lung function
Facility Information:
Facility Name
Cancer Specialists of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Oregon Oncology Specialists
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Cancer Care Associates of York, Inc.
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Tranquil Clinical Research
City
Webster
State/Province
Texas
ZIP/Postal Code
16969
Country
United States
Facility Name
Northwest Medical Specialties PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
UZA
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Ziekenhuizen K.U.Leuven, Campus gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHA Libramont
City
Libramont
ZIP/Postal Code
6800
Country
Belgium
Facility Name
Clinique Saint-Pierre asbl
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
vzw Verenigde Ziekenhuizen van Waas en Durme - VITAZ
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
LTD "Brothers"
City
Batumi
ZIP/Postal Code
6010
Country
Georgia
Facility Name
ARENSIA Exploratory Medicine LLC
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Ltd Israeli-Georgian Medical Research Clinic Helsicore
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
LTD "Health House"
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Facility Name
Ltd "Multiprofile Clinic Consilium Medulla "
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
PanAmerican Clinical Research Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Facility Name
PanAmerican Clinical Research Cuernavaca
City
Cuernavaca
ZIP/Postal Code
66290
Country
Mexico
Facility Name
PanAmerican Clinical Research, Queretaro
City
Querétaro
ZIP/Postal Code
76100
Country
Mexico
Facility Name
IMSP Institutul Oncologic, Arsenia Exploratory Medicine
City
Chisinau
ZIP/Postal Code
MD-2025
Country
Moldova, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Study of Lerociclib in Participants With Advanced Breast Cancer

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