A Phase IV multicentre, open label study of postmenopausal women with oestrogen receptor positive locally advanced or metastatic breast cancer treated with everolimus (RAD001) in combination with exemestane, with exploratory epigenetic marker analysis - 4EVERUK

Phase 1

• Conditions: oestrogen receptor positive breast cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003689-41-GB
• Lead Sponsor: ovartis Pharmaceuticals UK Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-18
• Study Completion: 2016-08-15
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 49

Inclusion Criteria

1. Adult women (= 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy or any other non-systemic treatment.
2. Histological or cytological confirmation of oestrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.
3. Availability of archival tumour tissue (the tissue block or slides will be sent to the central laboratory for analysis).
4. Postmenopausal women. The investigator must confirm postmenopausal status.
5. Disease progression following prior therapy with NSAI

Other inclusion criteria will apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1. HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).
2. Pre-menopausal, pregnant, lactating women.
3. Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin) or to their excipients.
4. Known hypersensitivity to exemestane, to the active substance or to any of the excipients.

Other exclusion criteria will apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: overall response rate at 48 weeks;<br> Secondary Objective: Progression free survival (PFS)<br> Overall survival (OS)<br> Quality of life (EORTC-QLQ30 and the EQ-5D)<br> Safety<br> ;Primary end point(s): overall response rate;Timepoint(s) of evaluation of this end point: 48 weeks

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Progression-free survival<br> Overall survival<br> Quality of life<br> Aberrant methylation and miRNA profiles from cir-DNA<br> Genome-wide measurements in tumour DNA, RNA and protein<br> ;Timepoint(s) of evaluation of this end point: 12 weekly, End of Trial and at Follow-up