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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-08

Study Completion Date

2025-08-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase 1/2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCE®) in Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer

NCT04072952

Breast Cancer

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

Vepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer

NCT05909397

Breast Cancer

ACTIVE_NOT_RECRUITING PHASE3

Efficacy and Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer

NCT00426556

Metastatic Breast Cancer

COMPLETED PHASE1

Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer

NCT00426530

Breast Neoplasms Neoplasm Metastasis

COMPLETED PHASE1

Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer

NCT00876395

Breast Cancer

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ARV-471 and Everolimus

ARV-471 oral tablets in combination with everolimus administered daily in 28 day cycles

Group Type EXPERIMENTAL

ARV-471 in combination with Everolimus

Intervention Type DRUG

ARV-471 oral tablets in combination with everolimus administered daily in 28 day cycles

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ARV-471 in combination with Everolimus

ARV-471 oral tablets in combination with everolimus administered daily in 28 day cycles

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No