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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 belowSelect...
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.
Select...
I have had one prior chemotherapy for my advanced cancer.
Select...
I am 18 years old or older.
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
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 moreSecondary 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 moreSide effects data
From 2023 Phase 1 trial • 12 Patients • NCT056526608%
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
4,669 Previous Clinical Trials
17,861,707 Total Patients Enrolled
113 Trials studying Breast Cancer
41,126 Patients Enrolled for Breast Cancer
Arvinas Estrogen Receptor, Inc.Lead Sponsor
18 Previous Clinical Trials
2,230 Total Patients Enrolled
7 Trials studying Breast Cancer
1,437 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with hormone therapy for my advanced cancer for at least 6 months.My cancer's size or presence can be measured by scans done within the last 28 days.I have had 2 or fewer chemotherapy treatments for my advanced disease.My breast cancer is ER+ and HER2-, and standard treatments no longer work.I haven't had radiation that affected more than 25% of my bone marrow or any in the last 4 weeks, except for pain relief.I am postmenopausal due to surgery or naturally.I have had one prior chemotherapy for my advanced cancer.I haven't taken any cancer treatment or experimental drugs in the last 14 days.I have had at least 2 hormone therapies and up to 3 chemotherapy treatments for my cancer.I am willing to have two biopsies for the study.I have been treated with a CDK4/6 inhibitor.I have brain metastases but am stable and off high-dose steroids for 4 weeks.I have undergone at least one hormone therapy treatment.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: ARV-471 and palbociclib (IBRANCE®)
- Group 2: ARV-471
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.