Overview

A Study of Lerociclib in Women With Advanced Breast Cancer

Status:
Not yet recruiting
Trial end date:
2026-05-01
Target enrollment:
0
Participant gender:
Female
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 women with HR+/HER2- MBC. The study population will consist of either newly diagnosed, treatment naïve women with HR+/HER2- MBC (1L population) or women with HR+/HER2- MBC who have already progressed on first line endocrine therapy such as tamoxifen, anastrozole, or letrozole (2L population). All participants must either be postmenopausal or receiving active ovarian suppression (goserelin).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
EQRx, Inc.
Treatments:
Fulvestrant
Letrozole
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 (loco regionally 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. 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 received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant
chemotherapy) or any CDK4/6 inhibitor.

7. Has received prior treatment with fulvestrant.

8. Participant is currently receiving any of the following substances and cannot be
discontinued 7 days prior to start the treatment:

- Known strong inducers or strong inhibitors of CYP3A4/5.

- Those that have a known risk to prolong the QT interval or induce Torsades de
Pointes.

- Those that have a narrow therapeutic window and are predominantly metabolized
through CYP3A4/5.

9. Echocardiogram done within the past 12 months with ejection fraction of ≤ 45% or
documented history of congestive heart failure with reduced ejection fraction.

10. Evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or
oral temperature > 38°C at screening

11. Interstitial pneumonia or severe impairment of lung function