Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing
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
Historically, serial testing of patients with metastatic breast cancer has included a combination of physical exam, symptom evaluation, laboratory testing, and imaging. Circulating tumor biomarkers are sometimes also incorporated. Frequent testing with numerous diagnostics at each time point is a significant burden to patients and to healthcare systems. The DiviTum® TKa assay measures TK1 activity. Numerous studies have illustrated the prognostic nature of plasma or serum TK1 activity level in metastatic cancer. The investigators hypothesize that the incorporation of data from DiviTum® TKa measurement into the treatment monitoring schema will be associated with physician desire to change the near-term usage and/or timing of other routine restaging tests, including either standard tumor imaging or tumor marker testing. Given the relatively low rate of disease progression in this first-line population, it is expected that most of this change will be an intended reduction in scheduling of routine treatment surveillance testing with increase in intervals of subsequent tumor restaging imaging by at least 4 weeks. Secondarily, the consequences of rescheduling of routine surveillance testing may ultimately result in an absolute reduction in the number of some tests used during the time period examined.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Zaawansowany lub rozprzestrzeniający się rak piersi wrażliwy na hormony (HR+) i odporny na HER2, potwierdzony badaniem obrazowym w ciągu 4 tygodni przed rozpoczęciem badania
- •Grupa 1: Planowane rozpoczęcie leczenia kombinacją hormonalną i inhibitorem CDK 4/6, lub wcześniejsza progresja na samym leczeniu hormonalnym, lub rozpoczęte leczenie hormonalne z zamiarem dodania inhibitora CDK 4/6
- •Grupa 2: Aktualnie przyjmowanie pierwszej linii leczenia kombinacją hormonalną i inhibitorem CDK 4/6, z co najmniej stabilnym stanem choroby przez 12 tygodni; leczenie CDK 4/6 rozpoczęte w ciągu ostatnich 24 miesięcy
- •Poprzednie leczenie raka piersi we wczesnym stadium (hormonalne lub chemioterapia) jest dozwolone
- •Wiek co najmniej 18 lat
- •Spodziewana długość życia powyżej 6 miesięcy
- •Status postmenopauzalny: wiek ≥60 lat, lub amenorrhea przez 12 miesięcy, lub usunięcie jajników/macicy, lub tłumiona funkcja jajników
- •Zdolność do zrozumienia i podpisania świadomej zgody
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 6, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Washington University School of Medicine
St Louis, United States
Trial contact
Nusayba Bagegni, M.D.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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