MedTrace Logo

Preoperative Estetrol in Breast Cancer

NCT00464516 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-07-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

placebo

once daily for 14 days orally

DRUG

Estetrol

once daily for 14 days orally

Sponsors & Collaborators

  • Pantarhei Bioscience

    lead INDUSTRY

Principal Investigators

  • Christian F Singer, MD, MPH · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2009-02-28
Completion
2010-03-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00464516 on ClinicalTrials.gov