Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK4/6 Inhibitor Failure (DAWNA-FES)

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

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About the trial

CDK4/6 inhibitors are currently the standard treatment for female breast cancer patients with HR+ tumors. However, there is no established standard treatment for patients who experience treatment failure with CDK4/6 inhibitors. The MAINTAIN study has shown clinical benefits by switching to Ribociclib and changing endocrine therapy after progression on CDK4/6 inhibitors. We hypothesize that combining Dalpiciclib with physician-selected endocrine therapy, following treatment failure with CDK4/6 inhibitors, would similarly lead to improved patient survival. In this study, 18F-FES PET/CT will be employed as a non-invasive alternative to biopsy techniques for evaluating the expression of ER in various systemic lesions of the patients.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wyniki badań wykazały, że rak piersi ma cechy HR-dodatnie i HER2-ujemne.
  • •Specjalistyczne badanie obrazowe (PET/CT z 18F-FES) potwierdziło obecność komórek nowotworowych reagujących na hormony.
  • •Ogólny stan zdrowia pacjentki pozwala na udział w badaniu (oceniane według skali ECOG).
  • •Przewidywany czas życia pacjentki wynosi co najmniej 3 miesiące.
  • •Pacjentka wcześniej otrzymywała określone leczenie, w tym terapie celowane (inhibitory CDK4/6) oraz chemioterapię lub leczenie hormonalne.
  • •Pacjentka wyraża zgodę na wykonanie standardowego badania PET/CT z 18F-FDG.
  • •Wykryto co najmniej jedną zmianę nowotworową poza czaszką, którą można zmierzyć.
  • •Funkcje ważnych organów pacjentki są w normie i pacjentka wyzdrowiała z ewentualnych skutków ubocznych poprzedniego leczenia.

✗ Disqualifies

  • •Badanie PET/CT z 18F-FES wykazało, że wszystkie komórki nowotworowe nie reagują na hormony.
  • •Pacjentka wcześniej przyjmowała lek Dalpiciclib.
  • •Potwierdzono przerzuty do opon mózgowo-rdzeniowych lub do mózgu.
  • •Pacjentka jest w stanie krytycznym, szybko postępuje choroba lub nie nadaje się do leczenia hormonalnego.
  • •Pacjentka ma wodobrzusze, objawowy płyn w jamie opłucnej lub osierdziu, który wymaga drenażu.
  • •Pacjentka ma trudności z połykaniem, niedrożność jelit lub inne problemy wpływające na przyjmowanie leków.
  • •Pacjentka chorowała na inne nowotwory w ciągu ostatnich 5 lat (z pewnymi wyjątkami dotyczącymi raka skóry).

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
80 Years
Last updated (source)
March 12, 2024
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

Peking Union Medical College Hospital

Beijing, China

Trial contact

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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