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Sponsored by: |
Pantarhei Bioscience |
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Information provided by: | Pantarhei Bioscience |
ClinicalTrials.gov Identifier: | NCT00464516 |
The study is designed as a single-center, randomized, double-blind, placebo-controlled study in pre- and postmenopausal women who will undergo surgery for breast cancer. Subjects will either receive estetrol or placebo during a 2 week treatment period.
Several biological markers, such as a cellular growth marker and cell death markers, will be assessed in the tumor tissue and surrounding normal tissue before and after the treatment period. During the 2 week interval between diagnosis of breast cancer and surgical resection, no therapy for breast cancer is usually administered.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: estetrol Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 30 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | April 2008 |
The study is designed as a single-center, randomized, double-blind, placebo-controlled study in pre- and postmenopausal women who will undergo surgery for breast cancer. Subjects will either receive estetrol or placebo during a 2 week treatment period.
Several biological markers, such as a cellular growth marker and cell death markers, will be assessed in the tumor tissue and surrounding normal tissue before and after the treatment period. In addition, receptor studies will be performed. During the 2 week interval between diagnosis of breast cancer and surgical resection, no therapy for breast cancer is usually administered.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects will be either pre- or post-menopausal.
Exclusion Criteria:
Previous use of estrogen/progestogen within:
Contraindications for using steroids:
Contact: Christian F Singer, MD, MPH | +43 1 40400 ext 2801 | christian.singer@meduniwien.ac.at |
Austria | |
University of Vienna | |
Vienna, Austria, 1090 |
Principal Investigator: | Christian F Singer, MD, MPH | Medical University of Vienna |
Study ID Numbers: | PR3076 |
Study First Received: | April 20, 2007 |
Last Updated: | April 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00464516 |
Health Authority: | Austria: Agency for Health and Food Safety |
Breast cancer (Estrogen Receptor positive) |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |