A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the 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 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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjentki mają co najmniej 18 lat.
- •Histologicznie potwierdzony rak piersi z przerzutami, reagujący na hormony (ER/PR-dodatni) i nieagresywny wobec HER2 (HER2-ujemny lub HER2-niski).
- •Pacjentki w pierwszej lub drugiej linii leczenia hormonalnego zaawansowanego raka piersi, po co najmniej 2 cyklach leczenia lekiem z grupy inhibitorów CDK4/6.
- •Pacjentki, u których choroba postępowała mimo leczenia hormonalnego i które otrzymały co najmniej 1 cykl chemioterapii kapecytabiną.
- •Ogólny stan zdrowia dobry (punktacja ECOG 0-1).
- •Zgoda na pobranie do dwóch próbek tkanki guza podczas badania.
- •Istnienie co najmniej jednego miejsca z guzem, które można pobrać do biopsji podczas leczenia.
- •Badania krwi wskazujące na prawidłową liczbę białych krwinek, limfocytów, neutrofilów i płytek krwi.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- April 6, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Fred Hutch/University of Washington Cancer Consortium
Seattle, United States
Trial contact
Research Coordinator(s)
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.