Preoperative Estetrol in Breast Cancer

NCT00464516 | Completed Phase 2

• 1 other identifier: PR3076
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

Breast cancer (Estrogen Receptor positive)

Outcome Measures

Primary Outcomes (1)

• To compare changes in the expression of a proliferation marker in malignant breast tissue after treatment with E4 or Placebo.

  14 days

Secondary Outcomes (4)

• To investigate treatment effects of Estetrol on apoptosis and apoptosis-related proteins in tumor tissue and in adjacent normal breast tissue.

  14 days

• To investigate hormone receptors, serum hormone levels and estetrol levels.

  14 days

• To investigate the effect of estetrol on the endometrium in women with an intact uterus.

  14 days

• To determine safety and tolerability of estetrol in women with Estrogen Receptor (ER) positive breast cancer

  21 days

Study Arms (2)

estetrol

EXPERIMENTAL

Drug: Estetrol

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

placebo DRUG

once daily for 14 days orally

placebo

Estetrol DRUG

once daily for 14 days orally

estetrol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of early invasive primary breast cancer (clinically stage I or II; T1 - T2; N0-1; M0, which requires surgery).
• The breast tumor size must be adequate for core cut biopsy to obtain sufficient amount of tissue for gene and protein expression analysis.
• Subjects will be either pre- or post-menopausal.
• BMI must be between 18 and 32 kg/m2.
• The patient must provide voluntary written informed consent.

You may not qualify if:

• 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
• Previous use of estrogen/progestogen within:
• months for depot preparations.
• weeks for oral preparations or progestogen containing IUD.
• weeks for transdermal preparations
• Use of hormone containing implant at any time
• Contraindications for using steroids:
• A history of, or existing thromboembolic, cardiovascular or cerebrovascular disorder.
• A history of, or existing conditions predisposing to, or being prodromi of, a thrombosis.
• A known defect in the blood coagulation system (e.g. deficiencies in AT-III, protein C, S, and APC resistance).
• A medical history positive for the presence of more than one risk factor for vascular disease (e.g. dyslipoproteinemia; diabetes mellitus; hyperhomocysteinemia; systemic lupus erythematosus; chronic inflammatory bowel disease; smoking; venous thromboembolism in sibling or parent below the age of 50, or arterial disease in sibling or parent below the age of 30-35).
• Hypertension, i.e. systolic blood pressure \>160 mm Hg and/or diastolic blood pressure \>100 mm Hg.
• Disturbance of liver function: cholestatic jaundice, a history of jaundice of pregnancy or jaundice due to previous estrogen use, Rotor syndrome and Dubin-Johnson syndrome.
• Any previous hormone-related malignancies within the last 5 years. History or presence of endometrial cancer. Exceptions are basaliomas of the skin and intraepithelial cervical neoplasias (CIN1-3).
• Undiagnosed vaginal bleeding.

Sponsors & Collaborators

• Pantarhei Bioscience: lead

Study Sites (1)

University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Estetrol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estriol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Christian F Singer, MD, MPH

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2007
• First Posted: April 23, 2007
• Study Start: April 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2010
• Last Updated: July 2, 2012

Record last verified: 2012-06

Locations

AU (1)