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Monoclonal Antibodies
Combination Immunotherapy for Advanced HER2+ Breast Cancer
Phase 2
Waitlist Available
Led By Ian Krop, MD, PhD
Research Sponsored by Ian E. Krop, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hepatic status: Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN), AST and ALT ≤ 2.5 × ULN; if the patient has liver metastases, ALT and AST must be ≤ 5 × ULN
Willingness and availability to submit FFPE tissue for central confirmation of HER2 positivity and central assessment of PD-L1 status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is studying how well the combination of drugs works in treating patients with breast cancer.
Who is the study for?
This trial is for adults with advanced HER2+ breast cancer that has progressed after previous treatments. Participants must have measurable disease, be in good physical condition (ECOG 0-1), and not be pregnant or breastfeeding. They should agree to use contraception and provide tissue samples. Key organ functions like kidney, liver, heart, and blood must meet specific criteria.Check my eligibility
What is being tested?
The AVIATOR study tests different drug combinations for HER2+ breast cancer: Group A gets Trastuzumab + Vinorelbine; Group B adds Avelumab to this combo; Group C includes all these plus Utomilumab. The goal is to compare the effectiveness of these regimens.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system due to drugs like Avelumab and Utomilumab, which may cause inflammation in various organs. Other common side effects can include fatigue, nausea from chemotherapy agents like Vinorelbine, and infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver function tests are within the required range.
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I am willing to provide tissue samples for HER2 and PD-L1 testing.
Select...
My breast cancer cannot be surgically removed and has spread.
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My cancer is HER2-positive or has ERBB2 amplification.
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I have been treated with ado-trastuzumab emtansine before.
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I am fully active or can carry out light work.
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My cancer has worsened after the latest treatment.
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
Progression Free Survival
Secondary outcome measures
Duration of Response
Objective Response Rate
Overall Survival
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Trastuzumab + Vinorelbine + Avelumab + UtomilumabExperimental Treatment4 Interventions
Trastuzumab is administered intravenously twice per cycle
Vinorelbine is administered intravenously 3 times per cycle
Avelumab is administered intravenously twice per cycle
Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab
Utomilumab is administered intravenously once per cycle
Group II: Trastuzumab + Vinorelbine + AvelumabExperimental Treatment3 Interventions
Trastuzumab is administered intravenously twice per cycle
Vinorelbine is administered intravenously 3 times per cycle
Avelumab is administered intravenously twice per cycle
Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab
Group III: Trastuzumab + VinorelbineExperimental Treatment2 Interventions
Trastuzumab is administered intravenously twice per cycle
Vinorelbine is administered intravenously 3 times per cycle
Group IV: Trastuzumab + Avelumab + UtomilumabExperimental Treatment3 Interventions
This is a crossover arm
Avelumab is administered intravenously twice per cycle
Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab
Utomilumab is administered intravenously once per cycle
Trastuzumab is administered intravenously twice per cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Utomilumab
2018
Completed Phase 2
~30
Vinorelbine
2013
Completed Phase 4
~2190
Avelumab
2018
Completed Phase 2
~2450
Find a Location
Who is running the clinical trial?
Ian E. Krop, MD, PhDLead Sponsor
1 Previous Clinical Trials
104 Total Patients Enrolled
1 Trials studying Breast Cancer
104 Patients Enrolled for Breast Cancer
Breast Cancer Research FoundationOTHER
68 Previous Clinical Trials
137,543 Total Patients Enrolled
40 Trials studying Breast Cancer
130,253 Patients Enrolled for Breast Cancer
Adrienne G. WaksLead Sponsor
3 Previous Clinical Trials
153 Total Patients Enrolled
2 Trials studying Breast Cancer
113 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver function tests are within the required range.You have tested positive for HIV.I have a history of lung scarring or fibrosis.My kidney function is normal, I don't have severe protein in my urine, and my blood clotting levels are stable.You had a strong allergic reaction to a different kind of medication called a monoclonal antibody before.I am currently on medication for an infection.I do not have severe high blood pressure, unstable diabetes, difficulty breathing at rest, or need for ongoing oxygen therapy.You have experienced serious side effects from a different experimental drug that have not been resolved or are not stable.I have not received any live vaccines in the last 30 days and will not during the trial.I am 18 years old or older.Your heart's pumping ability is normal (LVEF ≥ 50%).I am willing to provide tissue samples for HER2 and PD-L1 testing.Your blood counts need to be at certain levels: a certain number of white blood cells, platelets, and hemoglobin.Women who can have babies need to have a negative pregnancy test within 7 days of starting treatment.I have signed the consent form for participating in the trial and for my biological samples to be used.I have previously received immunotherapy targeting PD-1, PD-L1, 4-1BB, or CTLA4.I haven't had cancer treatment in the last 3 weeks or still have side effects.My breast cancer cannot be surgically removed and has spread.My cancer is HER2-positive or has ERBB2 amplification.I have been treated with ado-trastuzumab emtansine before.I have been treated with trastuzumab and pertuzumab for cancer.I am fully active or can carry out light work.I have or had an autoimmune disease.I do not have any health conditions that would make it unsafe for me to join the trial.My cancer has spread to my brain.I am on long-term medication that weakens my immune system.You have a disease that can be measured using specific guidelines.My cancer has worsened after the latest treatment.I have a serious or uncontrolled heart condition.You have a positive test for Hepatitis B or Hepatitis C.
Research Study Groups:
This trial has the following groups:- Group 1: Trastuzumab + Vinorelbine + Avelumab
- Group 2: Trastuzumab + Vinorelbine + Avelumab + Utomilumab
- Group 3: Trastuzumab + Vinorelbine
- Group 4: Trastuzumab + Avelumab + Utomilumab
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.
What is the total capacity of participants in this clinical trial?
"The sponsor of the trial, Pfizer, requires 100 eligible patients to be recruited across multiple sites. Two locations noted in particular are University of Washington located in Seattle and Memorial Sloan-Kettering Cancer Center situated in New york City."
Answered by AI
Have other trials been conducted that involved Utomilumab?
"Research into the effects of utomilumab began in 1999 at Ospedale di Circolo e Fondazione Macchi with a total 539 trials completed. Currently, 356 studies are active and many sites located around Seattle, Washington are actively contributing to this research effort."
Answered by AI
Are any new members being admitted to this clinical research?
"Affirmative. Records on clinicaltrials.gov indicate that the research study, posted to the website in June 2018 and updated August 2022, is currently recruiting participants. The trial requires 100 patients recruited from 18 separate locations."
Answered by AI
Has Utomilumab obtained authorization from the FDA?
"We believe the safety rating of utomilumab to be 2, as it is currently in clinical trial phase two and there is supportive evidence regarding its security but not efficacy."
Answered by AI
Are there multiple locations offering this research study within the city limits?
"This medical trial is being conducted at eighteen different sites, including renowned institutions like the University of Washington in Seattle and Memorial Sloan-Kettering Cancer Center in New york. Additionally, there are an additional sixteen locations participating in the study."
Answered by AI
In what instances is Utomilumab commonly prescribed?
"Utomilumab is regularly prescribed to treat metastatic adenocarcinoma of the stomach and its associated conditions, such as metastatic adenocarcinoma of the gastroesophageal junction, therapeutic procedure-related complications, and soft tissue sarcoma (STS)."
Answered by AI
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