Actively Recruiting
A Study of HLD-0117 in Patients With Metastatic Breast Cancer
Led by Halda Therapeutics OpCo, Inc. · Updated on 2026-04-13
33
Participants Needed
3
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of HLD-0117 in Patients With Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female (assigned at birth), 18 years or older, able to provide informed consent
- Histologically confirmed metastatic or locally advanced breast cancer
- Postmenopausal status by surgical or natural menopause, or ovarian suppression with a GnRH agonist
- Prior treatment including at least one endocrine therapy in metastatic setting and at least one CDK4/6 inhibitor
- No more than two prior cytotoxic regimens in metastatic setting
- Radiologic disease progression on most recent therapy
- Measurable disease per RECIST v1.1
- Willing 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 and recovery from prior therapy-related toxicities to Grade 1 (except alopecia; neuropathy and endocrinopathies 1Grade 2)
- Ability to swallow oral medication and comply with study procedures
- Stable dose (30 days) of bisphosphonates or denosumab, if applicable
You will not qualify if you...
- Inflammatory breast cancer or known brain metastases
- Recent major bleeding or uncontrolled bleeding disorder
- Ongoing corticosteroid use over 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 like 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
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Florida Cancer Specialists
Sarasota, Florida, United States, 34231
Actively Recruiting
2
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
3
NEXT Oncology
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
S
Study Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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