Advanced Breast CancerPhase 2NCT05085002
A Study of Lerociclib in Participants With Advanced Breast Cancer
A Phase 2 study testing Lerociclib + Letrozole or Fulvestrant in people with Advanced Breast Cancer, run by EQRx, Inc. at 21 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Lerociclib + Letrozole or Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 21 sitesin 6 countries
- Study dates
- 21 Dec 2021to 29 Nov 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
21 sites in 6 countries.
21 sites in 6 countries
United States6 sites
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Oregon Oncology Specialists
Salem, Oregon, 97301
Northwest Medical Specialties PLLC
Tacoma, Washington, 98405
Tranquil Clinical Research
Webster, Texas, 16969
Cancer Care Associates of York, Inc.
York, Pennsylvania, 17403
Belgium5 sites
UZA
Edegem, 2650
Ziekenhuizen K.U.Leuven, Campus gasthuisberg
Leuven, 3000
CHA Libramont
Libramont, 6800
Clinique Saint-Pierre asbl
Ottignies, 1340
vzw Verenigde Ziekenhuizen van Waas en Durme - VITAZ
Sint-Niklaas, 9100
Georgia5 sites
LTD "Brothers"
Batumi, 6010
ARENSIA Exploratory Medicine LLC
Tbilisi, 0112
Ltd Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, 0112
LTD "Health House"
Tbilisi, 0144
Ltd "Multiprofile Clinic Consilium Medulla "
Tbilisi, 0186
Mexico3 sites
PanAmerican Clinical Research Cuernavaca
Cuernavaca, 66290
PanAmerican Clinical Research Guadalajara
Guadalajara, Jalisco, 44670
PanAmerican Clinical Research, Queretaro
Querétaro, 76100
Italy1 site
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"
Meldola, 47014
Moldova1 site
IMSP Institutul Oncologic, Arsenia Exploratory Medicine
Chisinau, MD-2025
About this study
Official title: A Phase 2 Study to Evaluate the Safety and Efficacy of Lerociclib in Participants With Advanced Breast Cancer
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.
- Conditions
- Advanced Breast Cancer
- Being tested
- Lerociclib + Letrozole or Fulvestrant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lerociclib + Letrozole or FulvestrantDrug
Also called Goserelin acetate implant for pre- or perimenopausal female and male participants only
All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
| Study group | Role | What they receive |
|---|---|---|
| Lerociclib + letrozole or fulvestrant | Other | Letrozole, administered orally once daily in tablet form at 2.5 mg.
Fulvestrant, administered as an intramuscular injection, once every 2 weeks for the initial 3 doses and then once every 4 weeks (Q4W) thereafter, at 500 mg. Receives: Drug: Lerociclib + Letrozole or Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs and SAEs
The number and percentage of participants experiencing any TEAE and serious TEAE will be tabulated by line of therapy.
Measured: 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.
Secondary outcomes (3)
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).
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.
Measured: 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.
Probability of Progression-Free Survival (PFS)
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.
Measured: The timeframe for data collection was up to 18 months.
Description of Kaplan-Meier Estimates Analysis for Progression-free Survival Event Analysis
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start21 Dec 2021
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Why it stopped: The study is being closed based on corporate changes at EQRx and is not related to any efficacy or safety issues with lerociclib.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- EQRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085002
- Sponsor's protocol ID
- EQ132-201
- Status last verified
- Apr 2026
- First submitted
- 7 Sep 2021
- Last updated
- 14 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate the Safety and Efficacy of Lerociclib in Participants With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT05085002
- Acronym / sponsor ID
- EQ132-201
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study is being closed based on corporate changes at EQRx and is not related to any efficacy or safety issues with lerociclib.
- Enrolment
- 100 participants (actual)
- Lead sponsor
- EQRx, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Posted 14 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lerociclib + letrozole or fulvestrant | Other | Drug: Lerociclib + Letrozole or FulvestrantLetrozole, administered orally once daily in tablet form at 2.5 mg. Fulvestrant, administered as an intramuscular injection, once every 2 weeks for the initial 3 doses and then once every 4 weeks (Q4W) thereafter, at 500 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lerociclib + Letrozole or FulvestrantAlso: Goserelin acetate implant for pre- or perimenopausal female and male participants onlyAll participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID. | Drug | Lerociclib + letrozole or fulvestrant |
Primary outcome
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.
3 secondary outcomes
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.
Probability of Progression-Free Survival (PFS)
Time frame: The timeframe for data collection was up to 18 months.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lerociclib + Letrozole or Fulvestrant in people with Advanced Breast Cancer, run by EQRx, Inc. at 21 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Belgium, Georgia, Mexico, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.