NCT07524855 · Halda Therapeutics OpCo, Inc.
A Study of HLD-0117 in Patients With Metastatic Breast Cancer
(HLD-0117)
What this study is about
Assessment of the safety and effectiveness of HLD-0117 as treatment given alone in patients with estrogen receptor positive (ER+) metastatic breast cancer (MBC) or locally advanced breast cancer that have progressed on prior systemic therapies.
View original scientific description
Assessment of the safety and efficacy of HLD-0117 as monotherapy in patients with estrogen receptor positive (ER+) metastatic breast cancer (MBC) or locally advanced breast cancer that have progressed on prior systemic therapies.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- New Haven, Connecticut
- Sarasota, Florida
- Nashville, Tennessee
- Fairfax, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations