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Hormone Therapy
ARV-471 + Anastrozole for Breast Cancer
Phase 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
Clinical T1c-T4c, N0-N2, M0 breast cancer amenable to definitive surgical resection, without bilateral breast ductal carcinoma in situ or invasive breast cancer
Histologically or cytologically confirmed ER+ and HER2- breast cancer (per local assessment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5.5 months
Awards & highlights
Study Summary
This trial tests a new drug to treat breast cancer in post-menopausal women.
Who is the study for?
This trial is for post-menopausal women over 18 with ER+/HER2- localized breast cancer that can be surgically removed. Participants must have a tumor at least 1.5 cm large, an ECOG performance status of 0 or 1, and agree to multiple biopsies and surgery. Women with severe liver disease, recent heart issues, certain infections like HIV/HBV/HCV, other active cancers within the last three years or prior breast cancer treatments are excluded.Check my eligibility
What is being tested?
The study compares two treatments before surgery in women with a specific type of breast cancer: ARV-471 (a new therapy) versus Anastrozole (an established treatment). The goal is to see which one works better at shrinking tumors when given before removing them surgically.See study design
What are the potential side effects?
Possible side effects include typical reactions related to hormone therapies such as hot flashes, joint pain, and fatigue. There may also be risks associated with surgical procedures including infection and bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is at a stage that can be surgically removed and I don't have cancer in both breasts.
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My breast cancer is ER positive and HER2 negative.
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I am a woman over 18 and have gone through menopause.
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My cancer is estrogen receptor positive with at least 10% of cells affected.
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My cancer is not HER2 positive according to tests.
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I am fully active or can carry out light work.
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My cancer has a Ki-67 score of 5% or higher.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 5.5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5.5 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate the effects of ARV-471 and anastrozole, respectively, on Ki-67 expression in tumors after 2 weeks of treatment
Secondary outcome measures
Anastrozole
Anastrozole
Anastrozole
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ARV-471 monotherapyExperimental Treatment2 Interventions
ARV-471 taken once daily until surgical resection
Group II: Anastrozole monotherapyActive Control2 Interventions
Anastrozole 1mg taken once daily until surgical resection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARV-471
2022
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Arvinas Inc.Lead Sponsor
2 Previous Clinical Trials
465 Total Patients Enrolled
1 Trials studying Breast Cancer
215 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,721 Total Patients Enrolled
110 Trials studying Breast Cancer
36,252 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any cancer except for certain skin cancers or cervical pre-cancer in the last 3 years.I have not had serious heart rhythm problems in the last 6 months.I have ongoing stomach or bowel issues, like long-term diarrhea or surgeries.I have not had major surgery within the last 4 weeks.I haven't had a major heart or blood clot issue in the last 6 months.I have had treatment for breast cancer before, including chemotherapy, hormone therapy, radiation, or surgery.My breast cancer is at a stage that can be surgically removed and I don't have cancer in both breasts.The main tumor needs to be at least 1.5 cm when checked with imaging tests.My liver disease is severe (Child Pugh B or C).Your heart's electrical activity (QTcF) is longer than 470 milliseconds.I am willing to have biopsies and surgery as part of the study.I have not received any live vaccines in the last 14 days.My breast cancer is ER positive and HER2 negative.I am a woman over 18 and have gone through menopause.I do not have any active, uncontrolled infections including HBV, HCV, HIV/AIDS.My cancer is estrogen receptor positive with at least 10% of cells affected.My cancer is not HER2 positive according to tests.I am fully active or can carry out light work.My cancer has a Ki-67 score of 5% or higher.
Research Study Groups:
This trial has the following groups:- Group 1: ARV-471 monotherapy
- Group 2: Anastrozole monotherapy
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is ARV-471 monotherapy a viable option for patients seeking safe treatment?
"Our team at Power assigned a score of 2 to ARV-471 monotherapy's safety due to the lack of efficacy data available, despite some indications that it is safe."
Answered by AI
Are participants still able to join this research trial?
"As per the clinicaltrials.gov website, this clinical trial is currently recruiting participants. It was first announced on January 1st 2023 and updated most recently on January 26th of the same year."
Answered by AI
To what extent is participation in this research project limited?
"Affirmative. Data hosted on clinicaltrials.gov attests to the fact that this medical trial is still enrolling patients, after being initially posted on January 1st of 2023 and last updated at the end of said month. 150 volunteers are sought from a single site for participation in the study."
Answered by AI
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