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Anti-estrogen
Endocrine Therapy + Palbociclib + Avelumab for Breast Cancer (ImmunoADAPT Trial)
Phase 2
Waitlist Available
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
ImmunoADAPT Trial Summary
This trial is testing a new breast cancer drug, palbociclib, to see if it is more effective than current treatments.
Who is the study for?
This trial is for adults over 18 with Stage II-III estrogen receptor positive breast cancer, who haven't had metastatic disease or inflammatory breast cancer. They must have good organ function and performance status, agree to use contraception, and not be on certain medications or treatments that could interfere.Check my eligibility
What is being tested?
The study tests if adding palbociclib to endocrine therapy before surgery improves outcomes in breast cancer patients. After initial treatment, avelumab is added for three cycles before surgery. Participants are randomly assigned to receive either just endocrine therapy or the combination with palbociclib.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, blood cell count changes (which can increase infection risk), liver enzyme alterations, hair thinning or loss, mouth sores, and potential allergic reactions related to the drugs being tested.
ImmunoADAPT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Complete Response
Secondary outcome measures
Safety and Tolerability as determined by number of patients who experience Adverse Events
ImmunoADAPT Trial Design
2Treatment groups
Active Control
Group I: Endocrine TherapyActive Control2 Interventions
Eligible patients with ER-positive breast cancer will undergo a biopsy and be randomized to receive endocrine therapy (ET) versus endocrine therapy with palbociclib (PET) in a 1:2 ratio. A 1:2 ratio means that twice as many participants will be assigned to the PET arm as compared to the ET arm. After 1 cycle (28 days) another biopsy will be obtained, and both arms will receive avelumab (A) for 3 additional cycles. Patients will then undergo breast surgery.
Group II: Endocrine Therapy with PalbociclibActive Control3 Interventions
Eligible patients with ER-positive breast cancer will undergo a biopsy and be randomized to receive endocrine therapy (ET) versus endocrine therapy with palbociclib (PET) in a 1:2 ratio. A 1:2 ratio means that twice as many participants will be assigned to the PET arm as compared to the ET arm. After 1 cycle (28 days) another biopsy will be obtained, and both arms will receive avelumab (A) for 3 additional cycles. Patients will then undergo breast surgery.
Find a Location
Who is running the clinical trial?
Allegheny Health NetworkUNKNOWN
3 Previous Clinical Trials
558 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,506 Total Patients Enrolled
49 Trials studying Breast Cancer
110,752 Patients Enrolled for Breast Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,867 Total Patients Enrolled
43 Trials studying Breast Cancer
4,945 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to perform daily activities with little or no difficulty.You have a specific type and stage of breast cancer.You have cancer that has spread to other parts of the body, or you have inflammatory breast cancer.You are not likely to respond well to hormone-based therapy because of certain characteristics in your cancer, such as being PR-negative, high grade, having high gene expression, or showing a clinically aggressive presentation.You have taken hormone therapy like tamoxifen or aromatase inhibitors in the past 10 years.You have received treatment with CDK4/6 inhibitors or immune checkpoint inhibitors in the past.You have had allergic reactions to similar medications like tamoxifen, aromatase inhibitors, GnRH agonists, palbociclib, or avelumab.You have had an organ transplant or a stem-cell transplant from another person.Your tumor can be measured by ultrasound or by physical examination.You cannot have been diagnosed with cancer or received treatment in the last 3 years, except for certain types of skin cancer or cervical intraepithelial neoplasia. If you had breast cancer or treatment in the last 10 years, you are also excluded.You have a serious illness or condition that is not under control, such as an ongoing infection, heart problems, recent stroke or heart attack, or mental health issues that may affect your ability to follow the study rules or be safe in the study.You have severe ongoing medical conditions like immune colitis, inflammatory bowel disease, immune pneumonitis, or psychiatric conditions, or abnormal lab results that could make it risky for you to join the study.You have had an autoimmune disease in the past 3 years, except for certain conditions like vitiligo, alopecia, stable hypothyroidism, or psoriasis not needing strong medication.
Research Study Groups:
This trial has the following groups:- Group 1: Endocrine Therapy
- Group 2: Endocrine Therapy with Palbociclib
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.
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