ctDNA-guided Treatment Decision-making
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 is an exploratory, ctDNA-guided, multi-stage clinical study designed to evaluate the clinical value of treatment decision-making based on circulating tumor DNA (ctDNA) variant allele frequency (VAF) dynamics in patients with HER2-negative metastatic breast cancer. All enrolled patients will receive antibody-drug conjugate (ADC) therapy for two cycles in Stage 1, with serial ctDNA assessments performed prior to Cycle 1 and Cycle 2. In Stage 2, patients without disease progression will be assigned to different treatment strategies based on the percentage reduction in mean ctDNA VAF. The study aims to assess whether ctDNA VAF dynamics can serve as an early biomarker to guide treatment intensification and improve clinical outcomes in metastatic breast cancer.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek od 18 do 75 lat
- •Ogólny dobry stan zdrowia (pozwala na leczenie)
- •Potwierdzony przerzutowy rak piersi (HER2-ujemny)
- •Potwierdzona obecność zmian wymagających leczenia
- •Dobra praca narządów i szpiku kostnego
- •Przewidywana długość życia co najmniej 3 miesiące
- •Zgoda na pobranie próbek tkanki i krwi
- •Świadoma zgoda na udział w badaniu
✗ Disqualifies
- •Wcześniejsze leczenie tym samym rodzajem leku (ADC)
- •Aktywne przerzuty do mózgu
- •Ciężkie choroby serca lub płuc
- •Ciąża lub karmienie piersią
- •Ciężkie choroby autoimmunologiczne lub infekcje
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- February 6, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, China
Trial contact
Hongxia WANG
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.