Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT05501769
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed ER+ and HER2-advanced breast cancer (metastatic, recurrent, or unresectable)
* Women must be postmenopausal, or pre-/peri-menopausal women must be on ovarian suppression
* Measurable disease or non-measurable (evaluable) disease per RECIST v1.1
* Received a minimum of 1 and up to 3 lines of anti-cancer therapy in the advanced/metastatic setting: must have received and progressed on (or were intolerant to) a CDK 4/6 inhibitor, either alone or in combination; must have received at least one endocrine therapy, either alone or in combination; may have received up to one line of chemotherapy
* Must be willing to use dexamethasone mouthwash for the prevention of everolimus-induced stomatitis
* ECOG performance status of 0 or 1
Exclusion Criteria:
* Untreated brain metastases or brain metastases requiring steroids above physiologic replacement doses
* Prior treatment with ARV-471
* Prior treatment targeting mTOR (e.g. everolimus)
* Prior anticancer or investigational drug treatment within 28 days (fulvestrant) or 14 days (tamoxifen or aromatase inhibitor, or CDK 4/6 inhibitor) before the first dose of study drug
* Prior anticancer or investigational anticancer drug therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of study drug, except as mentioned above
* Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, or other clinically significant episode of thromboembolism
* Any of the following in the previous 6 months: congenital long QT syndrome, Torsade de Pointes, sustained ventricular tachyarrhythmia and ventricular fibrillation, left anterior hemiblock, ongoing cardiac arrythmias/dysrhythmias, atrial fibrillation
* Hypertension that cannot be controlled by medication (\>150/90 mmHg despite optimal medical therapy)
* Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus, hepatitis C virus, known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness
* Known history of drug-induced pneumonitis or other significant symptomatic deterioration of lung function
* Live vaccines within 14 days before the first dose of study drug
* Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug
* Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to more than 25% of the bone marrow
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05501769
Study Brief:
Protocol Section:
NCT05501769