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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
Must not have
History of interstitial lung disease
Active infection requiring systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of lung scarring or fibrosis.
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I am currently on medication for an infection.
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I do not have severe high blood pressure, unstable diabetes, difficulty breathing at rest, or need for ongoing oxygen therapy.
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I have not received any live vaccines in the last 30 days and will not during the trial.
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I have previously received immunotherapy targeting PD-1, PD-L1, 4-1BB, or CTLA4.
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I haven't had cancer treatment in the last 3 weeks or still have side effects.
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I have or had an autoimmune disease.
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My cancer has spread to my brain.
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I am on long-term medication that weakens my immune system.
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I have a serious or uncontrolled heart condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Progression Free Survival
Secondary study objectives
Duration of Response
Objective Response Rate
Overall Survival

Awards & Highlights

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

Trial Design

3Treatment groups
Experimental Treatment
Group I: NHAU: 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: NHA: 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: NH: Trastuzumab + VinorelbineExperimental Treatment2 Interventions
* Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Utomilumab
2017
Completed Phase 2
~30
Vinorelbine
2013
Completed Phase 4
~2190
Avelumab
2017
Completed Phase 2
~2440

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
74 Previous Clinical Trials
138,013 Total Patients Enrolled
42 Trials studying Breast Cancer
130,589 Patients Enrolled for Breast Cancer
Adrienne G. WaksLead Sponsor
3 Previous Clinical Trials
135 Total Patients Enrolled
2 Trials studying Breast Cancer
95 Patients Enrolled for Breast Cancer
Johns Hopkins UniversityOTHER
2,339 Previous Clinical Trials
14,881,531 Total Patients Enrolled
28 Trials studying Breast Cancer
23,451 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,675 Previous Clinical Trials
28,717,082 Total Patients Enrolled
114 Trials studying Breast Cancer
41,283 Patients Enrolled for Breast Cancer
Ian Krop, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
5 Previous Clinical Trials
400 Total Patients Enrolled
4 Trials studying Breast Cancer
320 Patients Enrolled for Breast Cancer
Adrienne Waks, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Avelumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03414658 — Phase 2
Breast Cancer Research Study Groups: NH: Trastuzumab + Vinorelbine, NHA: Trastuzumab + Vinorelbine + Avelumab, NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab
Breast Cancer Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT03414658 — Phase 2
Avelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03414658 — Phase 2
~13 spots leftby Jan 2026
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