Preoperative hormone therapy for pre- and postmenopausal women with ER positive breast cancer: A double blind randomized parallel group phase II trial, comparing the effect of 2 weeks of preoperative Estetrol with placebo - Preoperative estetrol
- Conditions
- breast cancer
- Registration Number
- EUCTR2006-006542-34-AT
- Lead Sponsor
- Pantarhei Bioscience B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
1. Histologically confirmed diagnosis of early invasive primary breast cancer
(clinically stage I or II; T1 – T3; N0-1; M0, which requires surgery).
2. The malignant tumor must be estrogen receptor (ER) positive as determined by the local pathologist at screening.
3. The breast tumor size must be adequate for core cut biopsy to obtain sufficient amount of tissue for gene and protein expression analysis.
4. Subjects will be either pre- or post-menopausal.
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
1.Any serious disease (e.g. severe liver or renal disease), clinically significant abnormal laboratory values (e.g. abnormal serum liver enzyme concentrations above the upper safety limit) or any other clinically significant abnormalities which, in the investigator’s opinion, may lead to adverse events during the course of the trial
2.Previous use of estrogen/progestogen within:
-6 months for depot preparations.
-8 weeks for oral preparations or progestogen containing IUD.
-4 weeks for transdermal preparations
3.Use of hormone containing implant at any time
4.Contraindications for using steroids
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare changes in the expression of the proliferation marker Ki-67 in malignant breast tissue after treatment with E4 or Placebo.;Secondary Objective: - To investigate treatment effects of E4 on apoptosis and apoptosis-related proteins in tumor tissue and in adjacent normal breast tissue.<br>- To investigate hormone receptors, serum hormone levels and E4 levels.<br>;Primary end point(s): The primary variable is the proportion of patients in each treatment arm with a relative reduction in the expression of the proliferation parameter Ki-67 in % between the pre-treatment and the post-treatment tumor biopsy.
- Secondary Outcome Measures
Name Time Method