HER2 BATs + Pembrolizumab for Breast Cancer
(Breast-47 Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byPatrick Dillon, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Virginia

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This proposal uses HER2Bi armed activated T-cells (HER2 BATs) to target breast cancer in combination with pembrolizumab (PBZ) in women with metastatic breast cancer (MBC). Phase I will determine a safe dose of the combination of PBZ and HER2 BATs in 3 to 18 patients. In the phase II portion, an additional 12 patients will be treated at the selected dose to further evaluate the safety and preliminary efficacy. Study treatment includes a combination of 8 infusions of BATs using a previously established schedule and one to three infusions of PBZ (200 mg per dose). PBZ will be added to 8 infusions of BATs in 3 schedules: #1) after the 8th BATs infusion; #2) after the 4th and 8th BATs infusions; and then, #3) before the 1st and after the 4th and 8th BATs infusions.

Eligibility Criteria

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.

Inclusion 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.

Be willing and able to provide written informed consent for the trial.

+11 more

Exclusion Criteria

I have stable brain metastases and haven't used steroids for at least 7 days.

Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

I am currently being treated for an infection.

+13 more

Participant Groups

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.

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.