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Hormone Therapy

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

Phase 1 & 2
Waitlist Available
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
No Placebo-Only Group

Summary

This trial is testing a new drug called ARV-471 alone and with palbociclib in patients with advanced breast cancer who have tried other treatments. ARV-471 breaks down proteins that help cancer grow, and palbociclib stops cancer cells from multiplying.

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.
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.
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.

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.
Select...
I have had 2 or fewer chemotherapy treatments for my advanced disease.
Select...
I am postmenopausal due to surgery or naturally.
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I have had one prior chemotherapy for my advanced cancer.
Select...
I am 18 years old or older.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Side effects data

From 2023 Phase 1 trial • 12 Patients • NCT05652660
8%
Abdominal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 1: Rosuvastatin
Period 2: ARV-471 + Rosuvastatin

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 2
~190

Find a Location

Who is running the clinical trial?

Arvinas Inc.Lead Sponsor
3 Previous Clinical Trials
514 Total Patients Enrolled
1 Trials studying Breast Cancer
152 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,642 Previous Clinical Trials
17,742,846 Total Patients Enrolled
114 Trials studying Breast Cancer
41,192 Patients Enrolled for Breast Cancer
Arvinas Estrogen Receptor, Inc.Lead Sponsor
17 Previous Clinical Trials
2,157 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
~35 spots leftby Oct 2025
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