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Trial NCT07524855

A Study of JNJ-101684362 (HLD-0117) in Patients With Metastatic Breast Cancer

Phase
Phase 1
Sponsor
Janssen Research & Development, LLC
Conditions
Metastatic Breast Cancer
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

Inclusion Criteria: * Female (assigned at birth), greater than or equal to (>=) 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 therapy including 1. Must have received at least one endocrine therapy in the metastatic setting. 2. Must have received at least one cyclin-dependent kinase (CDK) 4/6i, either in the adjuvant and/or metastatic setting. 3. For Part 1 and Part 2 Cohorts 2A, 2B, 2C, and 2D: Participants may have received up to two prior distinct cytotoxic regimens (for example, taxanes, antibody-drug conjugates (ADCs), etc.) in the metastatic setting, unless discussed and approved by the medical monitor. 4. For Part 2 Cohort 2E: Participants must have received more than two prior distinct cytotoxic regimens (for example, taxanes, ADCs, etc.) in the metastatic setting. * Radiologic disease progression on the most recent therapy * Patients must have disease evaluable per response evaluation criteria in solid tumors (RECIST) v1.1 1. For Part 1 and Part 2B, 2C, and 2E: Participants may have either evaluable or measurable disease per RECIST v1.1. 2. For Part 2 Cohort 2A: Participants should have measurable soft tissue disease per RECIST v1.1. 3. For Part 2 Cohort 2D: Participants should have evaluable but not measurable disease. * Willingness to provide baseline and on-treatment tumor biopsies, unless not feasible or medically appropriate * For Part 1 and Part 2 (all cohorts): 1. Participants must have documented >=10% ER staining and human epidermal growth factor receptor 2 (HER2) negative (per american society of clinical oncology [ASCO] college of american pathologists [CAP] guidelines) on the most recent tumor biopsy sample obtained. 2. For Part 2 Cohort 2B: Participants must have recent estrogen receptor 1 gene (ESR1) wild type from tumor or circulating tumor deoxy ribonucleic acid (ctDNA) testing performed after the most recent endocrine therapy prior to enrollment. 3. For Part 2 Cohort 2C: Participants must have ESR1 mutation detected from tumor or ctDNA testing performed prior to enrollment. * Eastern cooperative oncology group (ECOG) performance status 0-1 and life expectancy of at least 3 monthsPerformance status * 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: * Participants with Inflammatory breast cancer or leptomeningeal disease or brain metastases, with the exception of patients with definitively treated brain metastases that are clinically stable and asymptomatic for >2 weeks and who are off or receiving low-dose corticosteroid treatment (<=10 mg prednisone or equivalent) for at least 2 weeks prior to start of study treatment.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)HIV * 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)Prior malignancy * Major surgery within 28 days * Any condition that may interfere with safety or study compliance * Pregnancy or breastfeedingPregnancy

Restrictions found (5)

Recruiting in Massachusetts

  • Massachusetts General Hospital · Boston, Suffolk County