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CAR T-cell Therapy
HER2 BATs + Pembrolizumab for Breast Cancer (Breast-47 Trial)
Phase 1 & 2
Recruiting
Led By Patrick Dillon, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients are required to have at least one measurable non-bone lesion ≥10 mm that has not been irradiated.
Female patients of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 4.5.2, for the course of the study through 120 days after the last dose of study medication.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up blood will be collected about 5 weeks before any treatment, just before first her2 bats infusion, before her2 bats #5, before her2 bats #8, and 2 weeks, 1 month, 3 months, and 6 months after last pembrolizumab
Awards & highlights
Breast-47 Trial Summary
This trial will test a new treatment for breast cancer that uses a combination of 8 infusions of BATs and one to three infusions of PBZ. The goal is to determine if this is a safe and effective treatment for breast cancer.
Who is the study for?
This trial is for women over 18 with metastatic breast cancer who have had at least two prior treatments. They must have measurable disease, a life expectancy of more than 3 months, and be able to undergo apheresis. HER2 status can be positive or negative. Participants need functioning major organs and cannot be pregnant or breastfeeding. Exclusions include hypersensitivity to pembrolizumab, certain recent vaccines, active autoimmune diseases requiring treatment in the past two years, other cancers within five years (with some exceptions), and untreated brain metastases.Check my eligibility
What is being tested?
The study tests HER2Bi armed activated T-cells (HER2 BATs) combined with pembrolizumab on women with metastatic breast cancer. Phase I determines the safe dose for up to 18 patients; phase II treats an additional 12 patients at this dose to assess safety and effectiveness. The treatment involves eight infusions of BATs plus one to three doses of pembrolizumab in different schedules.See study design
What are the potential side effects?
Potential side effects may include immune reactions due to T-cell activation, infusion-related responses from both therapies, fatigue from the body's response to treatment, possible organ inflammation caused by pembrolizumab's effect on the immune system, as well as risks associated with any form of immunotherapy.
Breast-47 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor larger than 10 mm that has not been treated with radiation.
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I agree to use birth control during and up to 120 days after the study.
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I have undergone at least two treatments for cancer that has spread.
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I have a tumor that can be measured and has not been treated with radiation.
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I am a woman and I am 18 years old or older.
Select...
I am fully active or can carry out light work.
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My breast cancer has spread, and this was confirmed by a biopsy.
Breast-47 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ blood will be collected about 5 weeks before any treatment, just before first her2 bats infusion, before her2 bats #5, before her2 bats #8, and 2 weeks, 1 month, 3 months, and 6 months after last pembrolizumab
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~blood will be collected about 5 weeks before any treatment, just before first her2 bats infusion, before her2 bats #5, before her2 bats #8, and 2 weeks, 1 month, 3 months, and 6 months after last pembrolizumab
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Limiting Toxicities on each schedule/arm
Secondary outcome measures
Disease control rate
Dose Limiting Toxicities on the selected arm in the expansion cohort
Duration of response
+3 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Breast-47 Trial Design
3Treatment groups
Experimental Treatment
Group I: Schedule #3Experimental Treatment1 Intervention
At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7.
Group II: Schedule #2Experimental Treatment1 Intervention
At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 2 infusions of Pembrolizumab; the first given within weeks #3 - 4 and the second in week #7.
Group III: Schedule #1Experimental Treatment1 Intervention
At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 1 infusion of Pembrolizumab in week #7. No interventions within weeks #3 and 4.
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
757 Previous Clinical Trials
1,245,215 Total Patients Enrolled
10 Trials studying Breast Cancer
2,042 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,899 Previous Clinical Trials
5,062,829 Total Patients Enrolled
59 Trials studying Breast Cancer
7,406 Patients Enrolled for Breast Cancer
Patrick Dillon, MDPrincipal Investigator - University of Virginia
Martha Jefferson Hospital, University of Virginia Medical Center
University Of North Dakota School Of Medicine (Medical School)
6 Previous Clinical Trials
109 Total Patients Enrolled
4 Trials studying Breast Cancer
74 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer's hormone receptor and HER2 status will be checked.I have a tumor larger than 10 mm that has not been treated with radiation.I have stable brain metastases and haven't used steroids for at least 7 days.You are expected to live for at least 3 more months.My organ functions are within normal ranges as per recent tests.I am currently being treated for an infection.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.I am a woman who can have children and have a negative pregnancy test.I agree to use birth control during and up to 120 days after the study.I have undergone at least two treatments for cancer that has spread.I have a tumor that can be measured and has not been treated with radiation.I have HIV or a history of Hepatitis B or C, but if I have Hepatitis C, it's undetectable after treatment.I am a woman and I am 18 years old or older.I had cancer other than skin or early cervical cancer in the last 5 years.I have not received a live vaccine within the last 30 days, except for the flu shot.I have a history of serious heart problems.I have or had lung inflammation not caused by an infection.I am fully active or can carry out light work.You are allergic to PBZ or any of the ingredients in it.My breast cancer has spread, and this was confirmed by a biopsy.I have mostly recovered from side effects of my last cancer treatment, except for mild neuropathy.I have not needed systemic treatment for an autoimmune disease in the last 2 years.I have a history of active tuberculosis.My cancer's HER2 status has been tested.
Research Study Groups:
This trial has the following groups:- Group 1: Schedule #1
- Group 2: Schedule #3
- Group 3: Schedule #2
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 therapeutic benefits does the combined use of HER2 BATs and Pembrolizumab yield?
"HER2 BATs in combination with Pembrolizumab have been demonstrated to be effective for the treatment of malignant neoplasms, unresectable melanoma, and microsatellite instability high."
Answered by AI
How many participants are currently being recruited for the trial?
"Affirmative. Clinicaltrials.gov data indicates that the recruitment process for this experiment is still ongoing, having first been advertised on December 29th 2017 and recently updated on August 11th 2021. 33 patients need to be enrolled at one medical facility."
Answered by AI
Is enrollment for this experiment open to participants at this time?
"According to the clinicaltrials.gov database, this trial is still recruiting participants and was initially posted on December 29th 2017 with its most recent update being August 11th 2021."
Answered by AI
Has Pembrolizumab ever been utilized in conjunction with Human Epidermal Growth Factor Receptor 2 (HER2) Biologically Active Targeting Sites?
"At the time of writing, 961 clinical trials are underway to assess HER2 BATs with Pembrolizumab. Of these studies, 122 have reached the third phase and 35731 sites worldwide are running relevant studies. Houston, Texas is particularly active in this area of research."
Answered by AI
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