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Clinical Trials in the UK / NCT03742102
Active, not recruiting Phase 1/2

A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

NCT03742102 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 1/2
Started
2018-12-21
Last updated
2026-08-04

Condition(s) studied

Triple Negative Breast Neoplasms

Investigational drug(s) / intervention(s)

DurvalumabCapivasertibOleclumabPaclitaxelTrastuzumab deruxtecanDatopotamab deruxtecan

Durvalumab: Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8

Capivasertib: Capivasertib oral bid 4-week cycles; 3 weeks on (dosing on days 2,3,4 and 5) and 1 week off

Oleclumab: Oleclumab iv Every 2 weeks (q2w) for first 2 cycles (days 1 and 15 in cycles 1 and 2), then every 4 weeks (q4w) starting at cycle 3 day 1

Paclitaxel: Paclitaxel iv 4-week cycles: 3 weeks once weekly (q1w) and 1 week off

Trastuzumab deruxtecan: Trastuzumab deruxtecan iv 3-week cycles (once weekly) q3w

Datopotamab deruxtecan: Datopotamab deruxtecan iv 3-week cycles (once weekly) q3w

Study summary

This study is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel for first-line metastatic triple negative breast cancer

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion criteria 1. Female 2. At least 18 years of age at the time of screening 3. Patient must have locally confirmed advanced/unresectable or metastatic TNBC. 4. No prior treatment for metastatic (Stage IV) TNBC 5. Patient must have at least 1 lesion, not previously irradiated, that can be accurately measured 6. WHO/ECOG status at 0 or 1 at enrollment Patients enrolled to Arm 6 (durvalumab and DS-8201a) Must provide documentation of locally determined advanced/unresectable or metastatic TNBC with HER2 low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested) Patients enrolled in Arm 8 (durvalumab + Dato-DXd) Must have PD-L1 positive tumor as determined by an IHC based assay Exclusion criteria 1. History of allogeneic organ transplantation 2. Active or prior documented autoimmune or inflammatory disorders 3. Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen \[HBsAg\] result), hepatitis C virus (HCV), or human immunodeficiency virus (positive HIV 1/2 antibodies) 4. Untreated CNS metastases 5. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients 6. Any concurrent chemotherapy, IP, or biologic therapy for cancer treatment 7. Female patients who are pregnant, breastfeeding 8. Cardiac Ejection Fraction less than 50% Patients enrolled in Arm 2 only: 1. Potent inhibitors or inducers or substrates of CYP3A4 or substrates of CYP2C9 or CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort) 2. Diagnosis of diabetes mellitus Type I or diabetes mellitus Type II requiring insulin treatment. 3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval 4. Prior treatment with PI3K inhibitors, AKT inhibitors, or mammalian target of rapamycin (mTOR) inhibitors. Patients enrolled in Arm 5 only: History of venous thromboembolism in the past 3 months Patients enrolled in Arm 7 and 8 only: Clinically significant corneal disease in the opinion of the Investigator. Patients enrolled in Arm 6, 7 and 8 only: 1. History of or active interstitial lung disease/pneumonitis 2. Use of chloroquine or hydroxychloroquine in \<14 days prior to Day 1 of DS-8201a (Arm 6) or Dato-DXd (DS-1062a; Arm 7 and 8) treatment 3. Patients enrolled in Arm 6 only: Previously been diagnosed as HER2+ or received HER2-targeted therapy.

Primary outcome measure(s)

Trial sites (32)

FacilityCityRegionStatus
Research Site Tucson Arizona
Research Site Columbia Maryland
Research Site Boston Massachusetts
Research Site Boston Massachusetts
Research Site Grand Rapids Michigan
Research Site St Louis Missouri
Research Site Dallas Texas
Research Site Williamsburg Virginia
Research Site Kelowna British Columbia
Research Site London Ontario
Research Site Greenfield Park Quebec
Research Site Montreal Quebec
Research Site Gdansk Poland
Research Site Krakow Poland
Research Site Lublin Poland
Research Site Opole Poland
Research Site Rzeszów Poland
Research Site Warsaw Poland
Research Site Warsaw Poland
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Kaohsiung City Taiwan
Research Site Taichung Taiwan
Research Site Tainan Taiwan
Research Site Taipei Taiwan
Research Site Taipei Taiwan
Research Site Taoyuan Taiwan
Research Site Cambridge United Kingdom
Research Site London United Kingdom
Research Site Manchester United Kingdom
Research Site Oxford United Kingdom

On this site

📄 Imfinzi (durvalumab) drug profile → 📄 Enhertu (trastuzumab deruxtecan) drug profile →

More AstraZeneca trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03742102 on ClinicalTrials.gov ↗ ← All trials in the UK