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NCT07112053 · ClinicalTrials.gov registry record · Phase 2
A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer
A Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic HER2-Negative Breast Carcinoma, sponsored by University of Washington.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT07112053: Recruiting Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic HER2-Negative Breast Carcinoma, sponsored by University of Washington.
NCT07112053 is a Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic HER2-Negative Breast Carcinoma that is actively recruiting participants, run by University of Washington. The registered enrollment target is 40 participants, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07112053, a Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic HER2-Negative Breast Carcinoma, is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
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 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.
Primary Outcome
Safety and systemic toxicity will be determined by chemical and clinical parameters evaluated at various time points. Toxicity grading will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 6.0 and monitoring of AEs will be done per Food and Drug Administration and NCI guidelines. The type and grade of toxicities noted during the immunization regimen will be summarized. The duration of toxicities will also be summarized using des
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- DRUG Capecitabine
- BIOLOGICAL CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
- DRUG Cyclin-Dependent Kinase 4 Inhibitor
- DRUG Cyclin-Dependent Kinase 6 Inhibitor
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-11-17 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
What NCT07112053 shows while recruiting
NCT07112053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (76% lower).
The record links to 3 conditions, with Anatomic Stage IV Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT07112053 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT07112053 about?
NCT07112053 is a clinical study titled "A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer". 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 spr...
What is the current status of trial NCT07112053?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2025-11-17. Estimated completion is 2028-12-31.
What conditions does trial NCT07112053 study?
This clinical trial studies the following conditions: Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma.
What interventions are being tested in trial NCT07112053?
The interventions under investigation include: Computed Tomography (PROCEDURE), Capecitabine (DRUG), CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine (BIOLOGICAL), Cyclin-Dependent Kinase 4 Inhibitor (DRUG), Cyclin-Dependent Kinase 6 Inhibitor (DRUG).
Who is sponsoring clinical trial NCT07112053?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07112053 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07112053's enrollment target sits among peer trials
40 31st of 59 higher than 29 of 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage IV Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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