TPIV100 + Sargramostim for Breast Cancer

Recruiting at18 trial locations

Overseen by Saranya Chumsri

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Mayo Clinic

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a vaccine and a drug in patients with a specific type of breast cancer who still have cancer after chemotherapy. The vaccine helps the immune system target cancer cells, and the drug boosts white blood cells to strengthen this response. The goal is to see if this combination can better treat these patients.

Research Team

Saranya Chumsri

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for HER2 positive, stage II-III breast cancer patients with residual disease post-chemotherapy and surgery. Participants must have completed all planned surgeries and any radiation at least 30 days prior, have a certain level of blood cell counts, be willing to provide tissue/blood samples, use contraception if applicable, and not be pregnant. They should also have an ECOG performance status of 0-2.

Inclusion Criteria

Your hemoglobin level is at least 9.0 grams per deciliter, as measured within the past 28 days before the study starts.

Provide written informed consent

Willing to provide mandatory tissue and blood samples for correlative research purposes

Exclusion Criteria

I have taken medication like tamoxifen to prevent breast cancer within the last 2 months.

Person of child bearing potential who are unwilling to employ adequate contraception from the time of registration through 6 months after the final vaccine cycle

Your heart's pumping ability is less than 50%.

Treatment Details

Interventions

• Multi-epitope HER2 Peptide Vaccine TPIV100 (Cancer Vaccine)
• Sargramostim (Corticosteroid)

Trial Overview The trial is testing the effectiveness of TPIV100 (a vaccine targeting HER2 peptides) combined with sargramostim (which boosts white blood cells) in treating breast cancer that remains after initial treatments. It's also exploring why some patients respond better to chemotherapy when paired with trastuzumab and pertuzumab.

Participant Groups

Group I: Treatment (pCR) Experimental Treatment 2 Interventions

Patients receive standard of care maintenance therapy with trastuzumab and pertuzumab for 1 year in the absence of disease progression or unacceptable toxicity.

Group II: Arm I - No pCR (trastuzumab emtansine, TPIV100, sargramostim) Experimental Treatment 3 Interventions

Patients receive standard of care maintenance therapy with trastuzumab emtansine and receive TPIV100 ID and sargramostim ID on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive two additional booster injections of TPIV100 ID and sargramostim ID at 3 and 12 months after completion of trastuzumab emtansine maintenance therapy.

Group III: Arm II - No pCR (trastuzumab emtansine, placebo, sargramostim) Placebo Group 3 Interventions

Patients receive standard of care maintenance therapy with trastuzumab emtansine and receive placebo ID and sargramostim ID on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive two additional booster injections of placebo ID and sargramostim ID at 3 and 12 months after completion of trastuzumab emtansine maintenance therapy.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

Academic and Community Cancer Research United

Lead Sponsor

Trials

54

Recruited

4,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School