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Trial Title:
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
NCT ID:
NCT05501769
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Everolimus
Conditions: Keywords:
Advanced breast cancer
Metastatic breast cancer
MBC
Endocrine therapy
Estrogen receptor
ER+
human epidermal growth factor receptor 2
HER2-
ARV-471
Everolimus
PROTAC
Vepdegestrant
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ARV-471 in combination with Everolimus
Description:
ARV-471 oral tablets in combination with everolimus administered daily in 28 day cycles
Arm group label:
ARV-471 and Everolimus
Summary:
A phase 1b study to assess the combination of ARV-471 and everolimus in participants with
advanced or metastatic ER+/HER2- breast cancer.
Detailed 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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinical Trial Site
Address:
City:
San Diego
Zip:
92037
Country:
United States
Facility:
Name:
Clinical Trial Site
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Facility:
Name:
Clinical Trial Site
Address:
City:
Washington
Zip:
20007
Country:
United States
Facility:
Name:
Clinical Trial Site
Address:
City:
Lake Mary
Zip:
32746
Country:
United States
Facility:
Name:
Clinical Trial Site
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Facility:
Name:
Clinical Trial Site
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
Clinical Trial Site
Address:
City:
Barcelona
Zip:
08028
Country:
Spain
Facility:
Name:
Clinical Trial Site
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Facility:
Name:
Clinical Trial Site
Address:
City:
Valencia
Zip:
46018
Country:
Spain
Start date:
September 8, 2022
Completion date:
November 30, 2024
Lead sponsor:
Agency:
Arvinas Estrogen Receptor, Inc.
Agency class:
Industry
Collaborator:
Agency:
Pfizer
Agency class:
Industry
Source:
Arvinas Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05501769
