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Fulvestrant +/- Akt Inhibition in Advanced Aromatase Inhibitor Resistant Breast Cancer
Sponsor: Velindre NHS Trust
Summary
This is a two stage study, with an initial dose escalation phase I study and subsequent double blind randomised phase II controlled trial. Eligible patients are post-menopausal women with metastatic ER+ breast cancer not suitable for surgical resection. Patients should be suitable for endocrine treatment, but have received no more than 3 previous lines of endocrine treatment and up to 1 line of chemotherapy for metastatic disease. They will also have had progressive disease during treatment with an aromatase inhibitor. Following the dose-escalation in stage 1, patients will be randomised to receive fulvestrant plus either placebo or 480mg (or maximum tolerated dose) of AZD5363 oral capsules or tablets taken once daily. Patients will receive fulvestrant in combination with either placebo or AZD5363 until disease progression. Patients may continue to receive fulvestrant and AZD5363/placebo treatment even after the last trial visit.
Official title: A Phase 1b/2 Randomised Placebo Controlled Trial of Fulvestrant +/- AZD5363 in Postmenopausal Women With Advanced Breast Cancer Previously Treated With a Third Generation Aromatase Inhibitor
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
149
Start Date
2014-05-07
Completion Date
2025-12-31
Last Updated
2025-11-26
Healthy Volunteers
No
Conditions
Interventions
AZD5363
Up to 480mg oral tablets twice a day, taken four days on, 3 days off treatment.
Placebo
Placebo tablets taken twice a day, 4 days on treatment, 3 days off treatment
Fulvestrant
2 x 250mg injections, received on Days 1 and 15 of cycle 1, and on day 1 of each subsequent 28 day cycle.
Locations (21)
Velindre NHS Trust
Cardiff, Cardiff, United Kingdom
Christie Hospital
Manchester, Greater Manchester, United Kingdom
Ysbyty Gwynedd
Bangor, United Kingdom
Clatterbridge Cancer Centre
Bebington, United Kingdom
Royal Blackburn Hospital
Blackburn, United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom
University Hospital of North Durham
Durham, United Kingdom
Great Western General Hospital
Edinburgh, United Kingdom
Calderdale and Huddersfield NHS Foundation Trust
Huddersfield, United Kingdom
The Ipswich Hospital NHS Trust
Ipswich, United Kingdom
University Hospitals Morecambe Bay
Lancaster, United Kingdom
St James's University Hospital
Leeds, United Kingdom
Mount Vernon Cancer Centre
London, United Kingdom
Royal Free Hospital
London, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Royal Preston Hospital
Preston, United Kingdom
Glan Clwyd Hospital
Rhyl, United Kingdom
Queen's Hospital
Romford, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom
Royal Albert and Edward Infirmary -Wrightington
Wigan, United Kingdom