An Open Label Study of Postmenopausal Women With Oestrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Treated With Everolimus (RAD001) With Exemestane, With Exploratory Epigenetic Marker Analysis

PHASE4CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

August 15, 2016

Study Completion Date

August 15, 2016

Conditions
Oestrogen Receptor Positive Advanced Breast Cancer
Interventions
DRUG

RAD001

All postmenopausal women with oestrogen receptor positive locally advanced or metastatic breast cancer were treated with oral tablet RAD001 at a dose of 10mg daily and oral tablet exemestane 25mg daily. The study treatment for an individual patient was to begin on Study Day 1 and continue until the last patient enrolled completed the study at day 336 or until disease progression; unacceptable toxicity, death or early discontinuation from the study for any other reason, whichever occurs first.

DRUG

Exemestane

All postmenopausal women with oestrogen receptor positive locally advanced or metastatic breast cancer were to be treated with oral tablet RAD001 at a dose of 10mg daily and oral tablet exemestane 25mg daily. The study treatment for an individual patient was to begin on Study Day 1 and continue until the last patient enrolled completed the study at day 336 or until disease progression; unacceptable toxicity, death or early discontinuation from the study for any other reason, whichever occurs first.

Trial Locations (11)

CM16 6TN

Novartis Investigative Site, Epping

IV2 3RE

Novartis Investigative Site, Inverness

IP4 5PD

Novartis Investigative Site, Ipswich

SM2 5PT

Novartis Investigative Site, Sutton

CF14 2TL

Novartis Investigative Site, Cardiff

LL18 5UJ

Novartis Investigative Site, Denbighshire

G75 8RG

Novartis Investigative Site, East Kilbride

HU16 5JQ

Novartis Investigative Site, East Yorkshire

EH4 2XU

Novartis Investigative Site, Edinburgh

SW3 6JJ

Novartis Investigative Site, London

PO6 3LY

Novartis Investigative Site, Portsmouth

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY