breast cancer
Conditions
Interventions
Product Name: estetrol
Product Code: E4
Pharmaceutical Form: Oral solution
Pharmaceutical form of the placebo: Oral liquid
Route of administration of the placebo: Oral use
Sponsors
Pantarhei Bioscience B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. - To investigate hormone receptors, serum hormone levels and E4 levels. ;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. | — |
Countries
Austria
Outcome results
None listed