oestrogen receptor positive breast cancer
Conditions
Interventions
Trade Name: Afinitor 5 mg tablets
Product Code: RAD001
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
CAS Number: 159351-69
Sponsors
Novartis Pharmaceuticals UK Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: overall response rate at 48 weeks; Secondary Objective: Progression free survival (PFS) Overall survival (OS) Quality of life (EORTC-QLQ30 and the EQ-5D) Safety ;Primary end point(s): overall response rate;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression-free survival Overall survival Quality of life Aberrant methylation and miRNA profiles from cir-DNA Genome-wide measurements in tumour DNA, RNA and protein ;Timepoint(s) of evaluation of this end point: 12 weekly, End of Trial and at Follow-up | — |
Countries
United Kingdom
Contacts
Public ContactMedical Collaboration Centre
Novartis Pharmaceuticals UK Ltd
Outcome results
None listed