Breast Cancer Clinical Trial

ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer

Summary

A phase 1b study to assess the combination of ARV-471 and everolimus in participants with advanced or metastatic ER+/HER2- breast cancer.

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Full Description

This is a Phase 1b study to assess the safety and tolerability of ARV-471 in combination with everolimus in participants with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced or metastatic breast cancer, who have received a prior CDK4/6 inhibitor and endocrine therapy in the advanced/metastatic setting.

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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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

32

Study ID:

NCT05501769

Recruitment Status:

Recruiting

Sponsor:

Arvinas Estrogen Receptor, Inc.

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There are 5 Locations for this study

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Clinical Trial Site
San Diego California, 92037, United States
Clinical Trial Site
Santa Monica California, 90404, United States
Clinical Trial Site
Lake Mary Florida, 32746, United States
Clinical Trial Site
Ann Arbor Michigan, 48109, United States
Clinical Trial Site
Nashville Tennessee, 37203, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

32

Study ID:

NCT05501769

Recruitment Status:

Recruiting

Sponsor:


Arvinas Estrogen Receptor, Inc.

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