STEMVAC Vaccine for Metastatic Hormone Receptor Positive Breast Cancer

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

Recruiting Phase 2 Interventional Study
Anatomic Stage IV Breast Cancer AJCC v8 Metastatic HER2-Negative Breast Carcinoma Metastatic Hormone Receptor-Positive Breast Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
University of Washington · Other
Who this trial is looking for

This trial is looking for patients with advanced hormone receptor positive breast cancer. Participants will receive the STEMVAC vaccine along with standard therapies to see how well it works against cancer that has spread.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have hormone receptor positive metastatic breast cancer.
  • I have HER2-negative or low breast cancer.
  • I have a confirmed site of disease that can be biopsied.
  • I am willing to have up to two biopsies during the study.
  • I have a good performance status (ECOG score of 0 or 1).
  • I have normal blood cell counts and liver function.
  • Women of child-bearing potential will use effective contraception.

You may not be able to join if

  • I have serious heart conditions.
  • I have an autoimmune disease that needs steroids.
  • I have had another cancer needing treatment in the last 5 years.
  • I am pregnant or breastfeeding.
  • I have a history of HIV, hepatitis B, or hepatitis C.
  • I have had major surgery in the last 4 weeks.
  • I am currently taking immunosuppressants or systemic steroids.
  • I am enrolled in another clinical trial involving experimental treatment.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patients must be at least ≥ 18 years of age * Histologically confirmed hormone receptor positive metastatic breast cancer: Tumors that are positive for estrogen receptor (ER) and/or progesterone receptor (PR) * HER2-negative or HER2-low will be included and defined as: * 0-…
Contacts

Research Coordinator(s)

1-866-932-8588

cvitrial@uw.edu

CONTACT