PHOENIX DDR/Anti-PD-L1 Trial: A Pre-surgical Window of Opportunity and Post-surgical Adjuvant Biomarker Study of DNA Damage Response Inhibition With or Without Anti-PD-L1 Immunotherapy in Patients With Neoadjuvant Treatment Resistant Residual Triple Negative 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
PHOENIX is a window of opportunity (WOP), open-label, multi-centre, phase IIa trial comprising multiple non-comparative treatment cohorts with patient allocation via minimisation (cohorts A-D) or allocation according to HRD and germline BRCA1/2 mutation status (cohorts E-G). The trial consists of two parts: a post-neoadjuvant treatment preoperative WOP component (PART 1); and a post-operative component (PART 2). Cohorts A-D: To assess whether short exposure to a DDR inhibitor or anti-PD-L1 immunotherapy in a preoperative WOP in patients with post-NACT high risk residual disease, generates a signal of anti-tumour biological activity within residual disease tissue. Cohort E: To assess whether short exposure to a DDR inhibitor with or without anti-PD-1 immunotherapy in a preoperative WOP in patients with non-HRD associated TNBC and post-neoadjuvant treatment high risk residual disease, generates a signal of anti-tumour biological activity within residual disease tissue. Cohorts F \& G: To assess whether short exposure to the DDR inhibitor olaparib with or without anti-PD-1 immunotherapy in a preoperative WOP in patients with HRD associated TNBC and post-neoadjuvant treatment high risk residual disease, generates a signal of anti-tumour biological activity within residual disease tissue.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Podpisana świadoma zgoda na uczestnictwo w badaniu
- •Wiek 18 lat lub więcej
- •Potwierdzony nowotwór piersi typu triple negative (brak receptorów hormonalnych i HER2)
- •Planowane operacyjne leczenie po co najmniej 6 cyklach chemioterapii przedoperacyjnej
- •Guz widoczny w badaniach obrazowych i dostępny do biopsji
- •Stan ogólny pacjenta pozwala na operację i chemioterapię
- •Zdolność do udziału w badaniu przez co najmniej 2 tygodnie przed operacją
- •Zgoda na wykonanie biopsji przed i po leczeniu eksperymentalnym
✗ Disqualifies
- •Przerzuty nowotworu na odległe narządy
- •Poprzedni nowotwór złośliwy (inny niż rak piersi) - jeśli nie upłynęło 5 lat od leczenia
- •Warunki psychiczne, rodzinne lub społeczne uniemożliwiające uczestnictwo w badaniu
- •Ciąża lub brak zastosowania metod antykoncepcji przez co najmniej 6 miesięcy po badaniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 11, 2025
- Sex
- No restrictions
Therapies / drugs in trial
Locations (6)
Royal Bournemouth Hospital
Bournemouth, United Kingdom
King's College Hospital
London, United Kingdom
Christie Hospital NHS Trust
Manchester, United Kingdom
Velindre Cancer Center at Velinde Hospital
Cardiff, United Kingdom
Guy's and St Thomas' Hospital NHS Foundation Trust
London, United Kingdom
Weston Park Hospital
Sheffield, United Kingdom
Trial contact
Christophe Verstegen
Michelle Frost
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.