ARV-471 in combination with Everolimus for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Clinical Trial Site, San Diego, CA
Breast Cancer+1 More
ARV-471 in combination with Everolimus - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new combination drug treatment for advanced breast cancer. The treatment being studied is a combination of ARV-471 and Everolimus, which is already approved by the FDA for another condition. This treatment is being studied for its effects on breast cancer and is provided free of charge to participants. There will be no placebo group in this trial.

Eligible Conditions

  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Breast Cancer

Study Objectives

4 Primary · 6 Secondary · Reporting Duration: Up to approximately 1 year

28 calendar days after participant discontinues study treatment
Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-471 in combination with everolimus
Number of participants with adverse events as a measure of safety and tolerability of ARV-471 in combination with everolimus
35 Days
Incidence of dose limiting toxicities of ARV-471 in combination with everolimus
Recommended Phase 2 Dose (RP2D) for ARV-471 in combination with everolimus
Week 4
Area under the concentration-time curve over 24 hours at steady state (AUC(0-24)) of ARV-471 and everolimus
Maximum plasma concentrations (Cmax) of ARV-471 and everolimus
Time to maximum plasma concentrations (Tmax) of ARV-471 and everolimus
Year 1
Clinical benefit rate (CBR) in participants
Duration of response (DOR) in participants
Overall response rate (ORR) in participants

Trial Safety

Safety Progress

1 of 3

Other trials for Breast Cancer

Trial Design

1 Treatment Group

ARV-471 and Everolimus
1 of 1
Experimental Treatment

32 Total Participants · 1 Treatment Group

Primary Treatment: ARV-471 in combination with Everolimus · No Placebo Group · Phase 1

ARV-471 and Everolimus
Drug
Experimental Group · 1 Intervention: ARV-471 in combination with Everolimus · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 1 year
Closest Location: Clinical Trial Site · San Diego, CA
Photo of san diego 1Photo of san diego 2Photo of san diego 3
2003First Recorded Clinical Trial
2 TrialsResearching Breast Cancer
97 CompletedClinical Trials

Who is running the clinical trial?

Arvinas Estrogen Receptor, Inc.Lead Sponsor
3 Previous Clinical Trials
262 Total Patients Enrolled
2 Trials studying Breast Cancer
250 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,230 Previous Clinical Trials
6,667,027 Total Patients Enrolled
94 Trials studying Breast Cancer
27,895 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have ER+ and HER2-advanced breast cancer (metastatic, recurrent, or unresectable).
You have no or mild symptoms of cancer.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.