Fulvestrant +/- Akt Inhibition in Advanced Aromatase Inhibitor Resistant Breast Cancer

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

149

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

March 31, 2019

Study Completion Date

December 31, 2023

Conditions
Estrogen Receptor Positive Breast Cancer
Interventions
DRUG

AZD5363

Up to 480mg oral tablets twice a day, taken four days on, 3 days off treatment.

DRUG

Placebo

Placebo tablets taken twice a day, 4 days on treatment, 3 days off treatment

DRUG

Fulvestrant

2 x 250mg injections, received on Days 1 and 15 of cycle 1, and on day 1 of each subsequent 28 day cycle.

Trial Locations (21)

Unknown

Christie Hospital, Manchester

Ysbyty Gwynedd, Bangor

Clatterbridge Cancer Centre, Bebington

Royal Blackburn Hospital, Blackburn

Blackpool Victoria Hospital, Blackpool

Velindre NHS Trust, Cardiff

University Hospital of North Durham, Durham

Great Western General Hospital, Edinburgh

Calderdale and Huddersfield NHS Foundation Trust, Huddersfield

The Ipswich Hospital NHS Trust, Ipswich

University Hospitals Morecambe Bay, Lancaster

St James's University Hospital, Leeds

Mount Vernon Cancer Centre, London

Royal Free Hospital, London

Derriford Hospital, Plymouth

Royal Preston Hospital, Preston

Glan Clwyd Hospital, Rhyl

Queen's Hospital, Romford

Southampton General Hospital, Southampton

Royal Stoke University Hospital, Stoke-on-Trent

Royal Albert and Edward Infirmary -Wrightington, Wigan

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

Cenduit LLC

INDUSTRY

collaborator

Covance

INDUSTRY

collaborator

Cardiff and Vale University Health Board

OTHER_GOV

lead

Velindre NHS Trust

OTHER_GOV