Molecular profiling of postmenopausal women with breast cancer on neoadjuvant exemestane or tamoxife

Phase 1

• Conditions: Early or locally advanced breast cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2005-001698-89-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-03
• Study Completion: 2015-06-05
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 26

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

- 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

Study & Design

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