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Hormone Therapy

ARV-471 + Palbociclib for Breast Cancer (mBC Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Arvinas Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically or cytologically confirmed ER+ and HER2- advanced breast cancer for which standard curative therapy is no longer effective or does not exist

Patients in Part C must have received no more than two prior chemotherapy regimens for advanced disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to approximately 2 years

Awards & highlights

mBC Trial Summary

This trial will test a new drug, ARV-471, to see if it is safe and effective at treating advanced breast cancer. The trial will also test if the new drug is more effective when used in combination with another drug, palbociclib.

Who is the study for?

This trial is for postmenopausal women with ER+/HER2- advanced breast cancer who've had prior hormonal therapy and chemotherapy. They must have measurable disease, be over 18, willing to undergo biopsies, and can't have more than two prior chemo regimens for advanced disease or symptomatic brain metastases.Check my eligibility

What is being tested?

The study tests ARV-471's safety and effectiveness alone and with palbociclib in treating breast cancer that has spread or cannot be cured by standard treatments. It involves increasing doses to find the right amount and then expanding the group to further assess its effects.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones may include fatigue, nausea, hair loss from chemotherapy; plus potential new side effects from ARV-471 which will be closely monitored during the trial.

mBC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is ER+ and HER2-, and standard treatments no longer work.

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I have had 2 or fewer chemotherapy treatments for my advanced disease.

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I am postmenopausal due to surgery or naturally.

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I have had one prior chemotherapy for my advanced cancer.

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I am 18 years old or older.

mBC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part A: Incidence of Dose Limiting Toxicities of ARV-471

Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-471

Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-471

+3 more

Secondary outcome measures

Part A: Assessment of anti-tumor activity of ARV-471

Part A: Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC).

Part A: Assessment of pharmacokinetic parameter maximum concentration (Cmax).

+10 more

mBC Trial Design

2Treatment groups

Experimental Treatment

Group I: ARV-471 and palbociclib (IBRANCE®)Experimental Treatment1 Intervention

Part C: Daily oral dosages of ARV-471 for 28 days in combination with palbociclib (IBRANCE®) for 21 days.

Group II: ARV-471Experimental Treatment1 Intervention

Parts A and B: ARV-471 administered QD or BID for 28 day cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ARV-471

2022

Completed Phase 1

~50

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Arvinas Inc.Lead Sponsor

2 Previous Clinical Trials

402 Total Patients Enrolled

1 Trials studying Breast Cancer

152 Patients Enrolled for Breast Cancer

PfizerIndustry Sponsor

4,570 Previous Clinical Trials

10,915,811 Total Patients Enrolled

111 Trials studying Breast Cancer

36,229 Patients Enrolled for Breast Cancer

Arvinas Estrogen Receptor, Inc.Lead Sponsor

17 Previous Clinical Trials

2,154 Total Patients Enrolled

7 Trials studying Breast Cancer

1,440 Patients Enrolled for Breast Cancer

Media Library

ARV-471 (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04072952 — Phase 1 & 2

Breast Cancer Research Study Groups: ARV-471 and palbociclib (IBRANCE®), ARV-471

Breast Cancer Clinical Trial 2023: ARV-471 Highlights & Side Effects. Trial Name: NCT04072952 — Phase 1 & 2

ARV-471 (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04072952 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other similar studies to ARV-471 that have been done in the past?

"ARV-471 was first researched six years ago at Unimed Medical Institute. So far, 75 clinical trials have completed with more than one hundred still active. A great many of these ongoing studies are based in Norwalk, Connecticut."

Answered by AI

What are the primary indications for ARV-471?

"ARV-471 is a viable treatment option for patients that have breast cancer, malignant neoplasms, and are postmenopausal."

Answered by AI

Are there any available positions for patients in this research project?

"Yes, this study is currently looking for patients to participate. The trial was first posted on August 5th, 2019 and has been updated as recently as October 19th, 2022 according to the clinicaltrials.gov website."

Answered by AI

What is the total amount of people enrolled in this research project?

"In order for this study to be completed as planned, 215 patients must enroll. These individuals must meet the set inclusion criteria and can come from multiple locations, such as Norwalk Hospital in Connecticut or Moffitt Cancer Center in Florida."

Answered by AI

In how many different geographical areas is this clinical trial being performed?

"Currently, this clinical trial is being conducted at 20 sites. These locations include Norwalk, Tampa, and Charlotte. Additionally, there are 17 other places where this study is taking place. If you enroll in the trial, it would be ideal to choose a location that is close to minimize travel time and effort."

Answered by AI

What are the benefits that researchers hope to achieve from this clinical trial?

"The primary outcome of this trial will be the incidence of dose-limiting toxicities in patients receiving a combination of ARV-471 and palbociclib. Secondary outcomes include anti-tumor activity, pharmacokinetic parameters, and overall survival."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04072952.

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