Study on STEMVAC Vaccine with Standard Therapy for Treating Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer

Sponsor: University of Washington

Sponsor score: 40

ClinicalTrials ID:NCT07112053

Provider View

This clinical trial is testing a new vaccine called STEMVAC, combined with standard hormone therapy or chemotherapy, to treat breast cancer that is hormone receptor positive and HER2 negative, and has spread to other parts of the body.

Patient Parameters

Program Overview

This study is exploring how well a new vaccine, STEMVAC, works when used with standard hormone therapy or chemotherapy in patients with breast cancer that is hormone receptor positive and HER2 negative, and has spread beyond its original site. The vaccine aims to boost the immune system to target and destroy cancer cells. Standard hormone therapy works by altering hormone levels to slow or stop cancer growth, while chemotherapy drugs like CDK4/6 inhibitors and capecitabine work by stopping cancer cell growth or killing them. The combination of STEMVAC with these treatments may offer an effective approach for managing this type of breast cancer.

Description

The study is divided into two groups based on the type of treatment patients have received:

  • Cohort 1: Patients who are sensitive to hormone therapy will receive the STEMVAC vaccine after completing two cycles of standard hormone therapy combined with a CDK4/6 inhibitor. The vaccine is given in three initial doses every 28 days, followed by booster doses at 6 and 9 months, and then every 6 months if the cancer does not progress or cause severe side effects. Patients will also have CT or ultrasound-guided biopsies and blood samples taken for research.

  • Cohort 2: Patients who are resistant to hormone therapy will receive the STEMVAC vaccine after completing one cycle of capecitabine chemotherapy. The vaccine schedule is the same as in Cohort 1. These patients will also have CT or ultrasound-guided biopsies, blood samples, and special PET scans throughout the trial.

After finishing the study treatment, patients will be monitored every 6 months for 3 years to track their health and any changes in their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of hormone receptor positive metastatic breast cancer, meaning the cancer is positive for estrogen or progesterone receptors.
  • The cancer must be HER2 negative or low, based on specific medical tests.
  • Be receiving specific therapies:
    • Cohort 1: First or second line of hormone therapy with a CDK4/6 inhibitor.
    • Cohort 2: Have progressed on hormone therapies and completed at least one cycle of capecitabine.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have measurable metastatic disease based on standard criteria.
  • Be willing to undergo up to two biopsies during the study.
  • Have at least one site of disease that can be biopsied, not previously irradiated unless progression is shown.
  • Meet specific blood count and organ function criteria.
  • Agree to use effective contraception if of child-bearing potential, and have a negative pregnancy test at screening.
  • Must have recovered from major infections or surgeries and not have any significant active medical conditions that would prevent study treatment.

Exclusion Criteria

  • Have certain heart conditions, such as severe heart failure or uncontrolled arrhythmias.
  • Have autoimmune diseases or require chronic steroids or immunosuppressants.
  • Have had another cancer requiring treatment in the last 5 years.
  • Have allergies to the vaccine components.
  • Be pregnant or breastfeeding.
  • Have a history of HIV, hepatitis B, or hepatitis C infections.
  • Have had major surgery within 4 weeks before starting the study vaccine.
  • Be using immunosuppressive agents or systemic corticosteroids.
  • Be enrolled in another clinical trial involving experimental therapy.
  • Must wait 14 days between receiving a non-study vaccine and the STEMVAC vaccine, except for certain vaccines like tetanus and diphtheria.
  • Have any condition that may interfere with participation in the study.

Locations

FACILITYZIPCITYSTATE
Fred Hutch/University of Washington Cancer Consortium98109SeattleWashington

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