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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

243

Participants

Timeline

Start Date

December 21, 2018

Primary Completion Date

November 29, 2024

Study Completion Date

February 26, 2027

Conditions
Triple Negative Breast Neoplasms
Interventions
DRUG

Durvalumab

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

DRUG

Capivasertib

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

DRUG

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

DRUG

Paclitaxel

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

DRUG

Trastuzumab deruxtecan

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

DRUG

Datopotamab deruxtecan

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

Trial Locations (32)

112

Research Site, Taipei

333

Research Site, Taoyuan District

10002

Research Site, Taipei

21044

Research Site, Columbia

23188

Research Site, Williamsburg

40447

Research Site, Taichung

49503

Research Site, Grand Rapids

63110

Research Site, St Louis

70403

Research Site, Tainan City

75246

Research Site, Dallas

80756

Research Site, Kaohsiung City

85715

Research Site, Tucson

02114

Research Site, Boston

02215

Research Site, Boston

V1Y 5L3

Research Site, Kelowna

N6A 4L6

Research Site, London

J4V 2H1

Research Site, Greenfield Park

H4A 3J1

Research Site, Montreal

80-952

Research Site, Gdansk

31-501

Research Site, Krakow

20-090

Research Site, Lublin

45-060

Research Site, Opole

35-021

Research Site, Rzeszów

02-781

Research Site, Warsaw

04-141

Research Site, Warsaw

03080

Research Site, Seoul

05505

Research Site, Seoul

06351

Research Site, Seoul

CB2 0QQ

Research Site, Cambridge

EC1M 6BQ

Research Site, London

M20 4BX

Research Site, Manchester

OX3 7LE

Research Site, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY