REGYNERA(dia)TION is an international, multicenter, ambispective observational patient registry of adults with recurrent gynecologic malignancies after prior radiotherapy who are treated or planned for reirradiation and/or total ablative strategies as part of routine clinical care. The registry does not assign treatment. Radiotherapy technique, dose, systemic therapy, surgery, metastasis-directed therapy, imaging, and follow-up are selected by the treating multidisciplinary team according to local standards and patient-specific factors. The registry will collect harmonized retrospective and prospective data on disease characteristics, prior radiotherapy, recurrence pattern, reirradiation or ablative treatment exposure, response, progression, survival, severe treatment-related morbidity, fistula events, and patient-reported outcomes where available.
Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK4/6 Inhibitor Failure (DAWNA-FES)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
This trial is no longer recruiting — here are similar active trials
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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
Bo Pan, M.D.
Qiang Sun, 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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