Neoadjuvant Endocrinotherapy of Breast Cancer (Mamma Carcinoma) With Exemestane

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00291798
Recruitment Status : Completed
First Posted : February 15, 2006
Last Update Posted : September 19, 2006
Pharmacia Austria GmbH
Information provided by:
Austrian Breast & Colorectal Cancer Study Group

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: rate of remission Phase 2

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  (Clinical Trial)
Enrollment : 98 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Endocrinotherapy of Mamma Carcinoma With Exemestane
Study Start Date : September 2000
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Exemestane
U.S. FDA Resources

Primary Outcome Measures :
  1. rate of remission

Secondary Outcome Measures :
  1. Toxicity (WHO-grading)
  2. rate of mastectomy
  3. response of tumor subject to HER2-status
  4. collection of disease free survival and overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   59 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00291798

Hospital of Guessing
Guessing, Burgenland, Austria, 7540
State Hospital Klagenfurt, Surgery
Klagenfurt, Carinthia, Austria, 9026
State Hospital Wolfsberg
Wolfsberg, Carinthia, Austria, 9400
Hospital of Wiener Neustadt
Wiener Neustadt, Lower Austria, Austria, 2700
Gynaegological Medical University of Graz
Graz, Styria, Austria, 8036
Medical University of Graz, Oncology
Graz, Styria, Austria, 8036
Hospital BHS Linz
Linz, Upper Austria, Austria, 4010
General Hospital Linz
Linz, Upper Austria, Austria, 4020
Paracelsus Medical University Salzburg, Oncology
Salzburg, Austria, 5020
Medical University of Vienna, General Hospital
Vienna, Austria, 1090
Hanusch Hospital
Vienna, Austria, 1140
Sponsors and Collaborators
Austrian Breast & Colorectal Cancer Study Group
Pharmacia Austria GmbH
Study Chair: Brigitte Mlineritsch, MD Austrian Breast & Colorectal Cancer Study Group

Additional Information: Identifier: NCT00291798     History of Changes
Other Study ID Numbers: ABCSG-17
First Posted: February 15, 2006    Key Record Dates
Last Update Posted: September 19, 2006
Last Verified: February 2006

Keywords provided by Austrian Breast & Colorectal Cancer Study Group:
pilot study
mamma carcinoma

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs