ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
Completed · Phase 1
Conditions studied: Breast Cancer
In brief
A phase 1b study to assess the combination of ARV-471 and everolimus in participants with advanced or metastatic ER+/HER2- breast cancer.
Key facts
- Study ID
- NCT05501769
- Run by
- Arvinas Estrogen Receptor, Inc.
- People needed
- 32
- Starts
- 2022-09-08
- Expected to finish
- 2025-08-25
- Last updated by the study team
- 2025-09-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Clinical Trial Site — San Diego, California, United States
- Clinical Trial Site — Santa Monica, California, United States
- Clinical Trial Site — Washington D.C., District of Columbia, United States
- Clinical Trial Site — Lake Mary, Florida, United States
- Clinical Trial Site — Ann Arbor, Michigan, United States
- Clinical Trial Site — Nashville, Tennessee, United States
- Clinical Trial Site — Barcelona, Spain
- Clinical Trial Site — Madrid, Spain
- Clinical Trial Site — Valencia, Spain
Full record on ClinicalTrials.gov
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