Neoadjuvant Endocrinotherapy of Breast Cancer (Mamma Carcinoma) With Exemestane

September 18, 2006 updated by: Austrian Breast & Colorectal Cancer Study Group

Neoadjuvant Endocrinotherapy of Mamma Carcinoma With Exemestane

The objective of the present clinical investigation is to determine whether hormonal therapy given preoperatively is able to reduce tumor size to an extent that facilitates breast-conserving procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This open, prospective multicenter Phase II pilot trial investigates the efficacy of exemestane, 25 mg once daily over 4 months, in postmenopausal women with primary breast cancer, measured in terms of clinical response

Study Type

Interventional

Enrollment

98

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • Paracelsus Medical University Salzburg, Oncology
      • Vienna, Austria, 1090
        • Medical University of Vienna, General Hospital
      • Vienna, Austria, 1140
        • Hanusch Hospital
    • Burgenland
      • Guessing, Burgenland, Austria, 7540
        • Hospital of Guessing
    • Carinthia
      • Klagenfurt, Carinthia, Austria, 9026
        • State Hospital Klagenfurt, Surgery
      • Wolfsberg, Carinthia, Austria, 9400
        • State Hospital Wolfsberg
    • Lower Austria
      • Wiener Neustadt, Lower Austria, Austria, 2700
        • Hospital of Wiener Neustadt
    • Styria
      • Graz, Styria, Austria, 8036
        • Medical University of Graz, Oncology
      • Graz, Styria, Austria, 8036
        • Gynaegological Medical University of Graz
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • General Hospital Linz
      • Linz, Upper Austria, Austria, 4010
        • Hospital BHS Linz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

59 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically verified breast cancer (punch biopsy), established HER-2/neu status
  • Postmenopausal patients (> 1 year following outset of menopause and/or postmenopausal hormonal profile)
  • Clinical staging: T2 (> 3 cm), T3, T4a-c, N0-1
  • Hormone receptor positivity, i.e. estrogen and/or progesterone receptor > 10 fmol/mg cytosolic protein or ER-ICA-positive and/or PgR-ICA-positive. Positivity of + (low-grade) in one hormone receptor is only eligible in the presence of positivity in the other hormone receptor.
  • no internal contraindication
  • life expectation > 6 month
  • written informed consent

Exclusion Criteria:

  • premenopausal patients and patients with no clearly indicated menopausal status
  • manifest second malignant tumor (except basalioma or in situ carcinoma of cervix uteri)
  • uncontrolled internal disease i.e. diabetes mellitus, cardiac disease (NYHA III/IV)
  • thromboembolic disease
  • inflammatory mamma carcinoma
  • existence of distant metastases
  • former or simultaneously therapy with antioestrogens, aromatase inhibitors, cytostatics or radiotherapy
  • corticosteroids before and during the study (except inhalant application)
  • lack of compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
rate of remission

Secondary Outcome Measures

Outcome Measure
Toxicity (WHO-grading)
rate of mastectomy
response of tumor subject to HER2-status
collection of disease free survival and overall survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Austrian Breast & Colorectal Cancer Study Group

Collaborators

Pharmacia Austria GmbH

Investigators

  • Study Chair: Brigitte Mlineritsch, MD, Austrian Breast & Colorectal Cancer Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Study Completion

March 1, 2009

Study Registration Dates

First Submitted

February 14, 2006

First Submitted That Met QC Criteria

February 14, 2006

First Posted (ESTIMATE)

February 15, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

September 19, 2006

Last Update Submitted That Met QC Criteria

September 18, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABCSG-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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