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

Overview

No summary available.

Registry

who.int

Start Date

January 2, 2007

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•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

•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