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A Study of HLD-0117 for Metastatic Breast Cancer

This study is testing a drug called HLD-0117 for women with metastatic (spread to other parts of the body) or locally advanced breast cancer that is estrogen receptor positive (ER+). You may be able to join if you are at least 18 years old, postmenopausal, and your cancer has grown despite previous treatments, including at least one endocrine therapy and a CDK4/6 inhibitor. The main goals are to find out the safest dose of HLD-0117 and to see how well it works. The study is currently unclear on its recruitment status and plans to enroll 33 participants.

Study design
This is an open-label study, meaning you and your doctors will know you are receiving HLD-0117. It will involve a small number of participants, with at least three in each dose group, to find the best dose.
What's involved
You would receive HLD-0117 in 28-day cycles. Treatment may continue until your disease progresses or you need to stop for other reasons, such as side effects.
Compensation
Not stated in the trial record.
Follow-up
Safety will be checked for at least 28 days, including side effects, heart readings (ECGs), and lab tests.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07524855

A Study of HLD-0117 in Patients With Metastatic Breast Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~170 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:HLD-0117

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Limiting Toxicities (DLTs)
Measured over 28 days
+1 more outcome measured

Conditions

Metastatic Breast Cancer

Explore related trials

Breast CarcinomaESR1 Gene

Where it's being run

6 sites across 6 states
Connecticut1
Florida1
Massachusetts1
Tennessee1
Texas1
Virginia1

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Female (assigned at birth), ≥18 years old, and able to provide informed consent
Histologically confirmed metastatic or locally advanced breast cancer
Postmenopausal status defined by surgical or natural menopause, or ovarian suppression with a GnRH agonist
Prior treatment including at least one endocrine therapy in the metastatic setting, at least one CDK4/6 inhibitor (in the adjuvant and/or metastatic setting), and no more than two prior cytotoxic regimens in the metastatic setting
Radiologic disease progression on the most recent therapy
Measurable disease per RECIST v1.1
Willingness to provide baseline and on-treatment tumor biopsies, unless not feasible or medically appropriate
ER-positive and HER2-negative status documented within 2 years
ECOG performance status 0-1 and life expectancy of at least 3 months
Adequate organ function Recovery from prior therapy-related toxicities to Grade ≤1 (except alopecia; neuropathy and endocrinopathies ≤Grade 2)
Ability to swallow oral medication and comply with study procedures
Stable dose (≥30 days) of bisphosphonates or denosumab, if applicable

Exclusion

Inflammatory breast cancer or known brain metastases
Recent major bleeding or uncontrolled bleeding disorder
Ongoing corticosteroid use \>10 mg/day (prednisone equivalent)
Recent anticancer or investigational therapy within 14 days (28 days for fulvestrant)
Untreated or unstable spinal cord compression
Significant cardiovascular disease within 6 months or ongoing uncontrolled cardiac conditions
Active or uncontrolled infection (controlled HIV or treated hepatitis C allowed)
Uncontrolled renal, pancreatic, or liver disease (excluding stable conditions such as Gilbert's syndrome or liver metastases)
Another malignancy requiring treatment within 2 years (except low-risk, curatively treated cancers)
Major surgery within 28 days
Any condition that may interfere with safety or study compliance
Pregnancy or breastfeeding

What this trial measures

  • Dose Limiting Toxicities (DLTs)28 days

    Frequency of dose-limiting toxicities (DLTs)

  • AEs, ECGs, Labs and Clinical Changes28 days

    Frequency and severity of adverse events (AEs) and abnormal electrocardiogram (ECG), laboratory and clinical changes from baseline