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ACTIVE NOT RECRUITING
NCT01992952
PHASE1/PHASE2

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

Sponsor: Velindre NHS Trust

View on ClinicalTrials.gov

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

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.

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