Genomic and Transcriptomic Predictors of Sequential SG Sensitivity After T-DXd in ER+/HER2-Low Metastatic 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
Advanced hormone positive (HR+), HER2 negative breast cancer continues to pose a challenge when patients have progressed on CDK4/6 inhibitor and endocrine therapy leaving limited treatment options. Antibody-drug conjugates (ADCs) such as sacituzumab govitecan (SG) and trastuzumab deruxtecan (T-DXd) have changed practice due to significant improvement in progression free survival (PFS) and overall survival (OS) seen in this disease setting. There is a genuine interest to use SG sequentially after T-DXd, however there is no current prospectively curated evidence to support this strategy. Though the epitope is different, the payload are both topoisomerase I inhibitors. Thus, evidence is needed of both clinical efficacy and identification of mechanisms of sensitivity and resistance to sequential ADCs in HER-2 low MBC. It is hypothesized that performing whole genome and whole transcriptome sequencing in fresh tumour biopsies post progression of T-DXd and prior to SG in ER+/HER2 low metastatic breast cancer (MBC) will provide mechanistic insights into identifying biomarkers, and thus patients, sensitive to sequential SG.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Rак piersi zaawansowany lub rozsiany, dodatni na receptor estrogenowy, ujemny na HER2
- •Wcześniejsze leczenie hormonalne połączone z inhibitorem CDK4/6
- •Co najmniej jedna linia chemioterapii, ostatnio trastuzumab deruksotecan
- •Guz dostępny do bezpiecznego pobrania próbki
- •Ujemny test ciążowy u kobiet przed menopauzą i zgoda na antykoncepcję przez 12 tygodni po leczeniu
- •Stan ogólny pacjenta ECOG 0-2
- •Oczekiwana długość życia co najmniej 3 miesiące
✗ Disqualifies
- •Uczestnictwo w innym badaniu medycznym niezgodnym z tym badaniem
- •Uczulenie na lek SG, irinotekan lub jego metabolit
- •Niedostępność pacjenta do kontroli podczas badania
- •Brak zgody pacjenta na leczenie systemowe
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- June 25, 2025
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
BC Cancer - Vancouver Center
Vancouver, Canada
Trial contact
Stephen Chia, MD
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.