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

Summary

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.

Eligibility

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

Conditions3

Interventions1

Locations6 sites

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