A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT07112053
Phase
PHASE2
Status
Recruiting
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Conditions

  • Anatomic Stage IV Breast Cancer AJCC v8
  • Metastatic HER2-Negative Breast Carcinoma
  • Metastatic Hormone Receptor-Positive Breast Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine — BIOLOGICAL
    Given ID
  • Capecitabine — DRUG
    Given SOC capecitabine
  • Computed Tomography — PROCEDURE
    Undergo CT or ultrasound-guided biopsies
  • Cyclin-Dependent Kinase 4 Inhibitor — DRUG
    Given SOC CDK4/6i
  • Cyclin-Dependent Kinase 6 Inhibitor — DRUG
    Given SOC CDK4/6i
  • F-18 16 Alpha-Fluoroestradiol — DRUG
    Undergo FES PET
  • Hormone Therapy — DRUG
    Given SOC ET
  • Positron Emission Tomography — PROCEDURE
    Undergo PET or FES PET
  • Biopsy Procedure — PROCEDURE
    Undergo image-guided biopsies
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Abemaciclib — DRUG
    Given SOC abemaciclib

Study Details

This phase II trial studies how well a vaccine, STEMVAC, works in combination with standard endocrine-based therapy (ET) with a CDK4/6 targeted drug therapy, or with the chemotherapy drug capecitabine, in treating patients with hormone receptor (HR)-positive, HER2-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). STEMVAC is designed to target proteins that cancer cells use when they become more aggressive and start to spread, and it is believed to work by boosting the immune system to recognize and destroy the invader tumor cells that are causing the disease. Standard ET is treatment that adds, blocks, or removes hormones in order to slow or stop the growth of cancer. Standard CDK4/6 inhibitors, including abemaciclib, may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Giving STEMVAC in combination with standard ET or chemotherapy may be an effective treatment for metastatic HR positive, HER2 negative breast cancer.

Key Dates

Start date
Nov 17, 2025
Status verified
Mar 2026
Primary completion
Jul 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (STEMVAC, ET + CDK4/6i)
    After completion of 2 cycles of SOC ET + CDK4/6i therapy or abemaciclib alone, patients receive STEMVAC ID on the following schedule: 1) Three "priming" doses every 28 days; 2) Two "booster" doses at 6 and 9 months after "priming" dose #3; and 3) Additional "booster" doses every 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo image-guided biopsies, as well as collection of blood samples and CT or PET scans throughout the trial.
  • Experimental: Cohort 2 (STEMVAC, capecitabine)
    After completion of 1 cycle of SOC capecitabine treatment, patients receive STEMVAC ID on the following schedule: 1) Three "priming" doses every 28 days; 2) Two "booster" doses at 6 and 9 months after "priming" dose #3; and 3) Additional "booster" doses every 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo image-guided biopsies, collection of blood samples, and FES PET scans, as well as CT or PET scans throughout the trial.

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: Up to 3 years after completion of study treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Research Coordinator(s)
[email protected]
866-932-8588
Natasha Hunter, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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