Early or locally advanced breast cancer
Conditions
Interventions
Trade Name: Exemestane 25mg Film-coated Tablets
Product Name: Exemestane
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Exemestane
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Women with histological diagnosis of primary invasive breast cancer on core biopsy - Not a candidate for chemotherapy - Localised or locally advanced breast cancer - Ultrasound size at least 10mm - No previous treatment for breast cancer - ER positive (allred score >4) - Palpable and measureable disease in the breast or axilla - Post menopausal defined by the following criteria: cessation of menstrual periods for at least 1 year or bilateral surgical oophorectomy or follicular stimulating hormone (FSH) and oestradiol in the post-menopausal range - At least 2 weeks since prior hormone replacement therapy or phyto-oestrogens herbal, alternative, or over-the counter (OTC) sex hormone remedies and not on concomitant hormonal therapy with these agents - ECOG performance status 0,1or 2 - Randomisation and treatment within 4 weeks of biopsy - Patient must have adequate bone marrow, hepatic and renal function - Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial - Written consent for the trial 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 2 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: - Patient unfit to receive endocrine-based therapy - Previous history of cancer excluding basal cell carcinoma, cervical carcinoma in-situ, or ductal carcinoma in situ of the breast - Previous deep vein thrombosis or pulmonary embolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Identify molecular markers that will predict the response or resistance to endocrine therapy with exemestane or tamoxifen ;Main Objective: To perform prospective analysis of (i) gene expression profiles; (ii) previously identified candidate genes; and (iii) blood analysis, before, during, and after neoadjuvant therapy with exemestane or tamoxifen to identify genes, gene profiles and serum markers predictive of response and resistance.; Secondary Objective: - Clinical response rate (cRR) - Radiological response rate (rRR) - Changes in Ki67 index in response to therapy - Clinical/radiological response among patients over-expressing EGFR/HER-1, 2,3 & 4 - VEGF-A, p-PDGFR-beta, VEGFR-1 and VEGFR-2 expression, and changes in expression during treatment and correlation with clinical outcomes - Serum levels of VEGF-R and VEGF-A before, during and after treatment - Cadherin-11 and Transcription factor (AP-1, Ets-2, Cyclin D1, TTF-1, ERK-1/2) -Gene profiling to identify molecular markers of response and resistance | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Clinical response rate (cRR) - Radiological response rate (rRR) - Changes in Ki67 counts in response to therapy - Clinical/radiological response among patients over-expressing EGFR/HER-2 - Serum levels of VEGF-R and VEGF before, during and after treatment - Serum circulatory HER-2 ECD and CEC changes during treatment - VEGFA, VEGFR-1 and VEGFR-2 expression and correlation with clinical outcomes - Cadherin-11,Transcription factor (AP-1, Ets-2,cyclin D1) - Gene profiling to identify molecular markers of response or resistance | — |
Countries
United Kingdom
Contacts
Public ContactData Management Team
Cambridge University Hospitals NHS Foundation Trust
Outcome results
None listed