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

PHASE2RecruitingINTERVENTIONAL
Enrollment

119

Participants

Timeline

Start Date

October 15, 2019

Primary Completion Date

December 31, 2026

Study Completion Date

June 30, 2029

Conditions
Breast NeoplasmTriple Negative Breast Cancer (TNBC)HRD
Interventions
DRUG

AZD6738

"PART 1: Pre-operative exposure of 160mg AZD6738 to be administered orally twice daily on Days 5 -14 of the WOP.~PART 2: 12 months post-operative exposure to 160mg AZD6738 to be administered orally twice daily on Days 1 - 14 of a 28 day cycle.~AZD6738 was removed as intervention under investigation as of 06 August 2024 (due to formal closure of cohort B)"

DRUG

Olaparib

"PART 1 (cohort C, and cohorts E-G): Pre-operative exposure to 300mg of olaparib to be administered orally twice daily on Days 1-14 of the WOP.~PART 2 (cohort C, and cohorts F and G): 12 months post-operative exposure to 300mg olaparib (2 x 150mg tablets) to be administered orally twice daily on a continuous schedule Day 1-28 of a 28 day cycle.~Cohort C was formally closed to recruitment since 06 August 2024."

DRUG

Durvalumab

"PART 1 (cohort D): Pre-operative exposure to 1500mg durvalumab to be administered via intravenous (IV) infusion on Day 1 only of the WOP.~PART 2 (cohorts A and D, and cohorts F and G): 12 months post-operative exposure to 1500mg durvalumab to be administered via intravenous (IV) infusion on Day 1 only of a 28 day cycle.~Cohorts A and D were formally closed to recruitment since 06 August 2024."

Trial Locations (6)

BH7 7DW

NOT_YET_RECRUITING

Royal Bournemouth Hospital, Bournemouth

SE5 9RS

RECRUITING

King's College Hospital, London

M20 4BX

NOT_YET_RECRUITING

Christie Hospital NHS Trust, Manchester

CF14 2TL

RECRUITING

Velindre Cancer Center at Velinde Hospital, Cardiff

SE1 9RT

RECRUITING

Guy's and St Thomas' Hospital NHS Foundation Trust, London

Unknown

NOT_YET_RECRUITING

Weston Park Hospital, Sheffield

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Institute of Cancer Research, United Kingdom

OTHER