A randomized, prospective trial of 2-6 weeks pre-operative hormonal treatment for hormone receptor positive breast cancer: Anastrozole +/- Fulvestrant or Tamoxifen Exposure - response in molecular profile (AFTER study) - AFTER study
- Conditions
- Invasive Breast Cancer, tumor size >= 1 cm (NOT inflammatory breast cancer), no clues of metastatic disease, no multicentric breast cancer
- Registration Number
- EUCTR2008-000644-13-NL
- Lead Sponsor
- KI-AV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
•Patients with proven invasive adenocarcinoma of the breast
•Any tumor with a size = 1cm (NOT inflammatory breast cancer)
•WHO-performance score 0 or 1
•Written informed consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Clues of metastatic disease by clinical examination according to most recent NABON guidelines
•Multicentric breast cancer
•Inflammatory breast cancer
•Hormone replacement during the last 12 months
•Already planned date for surgery within the next 2 weeks
•Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol
•Patient’s refusal to undergo a core biopsy procedure of the primary tumor before the start of treatment
NB: a concomitant malignancy within the last five years is not an exclusion criterium, because survival is not the primary endpoint. Just as prior invasive breast cancer or DCIS within the last 15 years is not an exclusion criterium.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method