Neoadjuvant Endocrinotherapy of Breast Cancer (Mamma Carcinoma) With Exemestane

This study has been completed.

First Received on February 14, 2006. Last Updated on September 18, 2006 History of Changes

Sponsor:	Austrian Breast & Colorectal Cancer Study Group
Collaborator:	Pharmacia Austria GmbH
Information provided by:	Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:	NCT00291798

Purpose

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	Intervention	Phase
Breast Cancer	Procedure: rate of remission	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Neoadjuvant Endocrinotherapy of Mamma Carcinoma With Exemestane

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Exemestane

U.S. FDA Resources

Further study details as provided by Austrian Breast & Colorectal Cancer Study Group:

Primary Outcome Measures:

rate of remission

Secondary Outcome Measures:

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

Estimated Enrollment:	98
Study Start Date:	September 2000
Estimated Study Completion Date:	March 2009

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

Eligibility

Ages Eligible for Study:	59 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291798

Locations

Austria
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

Investigators

Study Chair:

Brigitte Mlineritsch, MD

Austrian Breast & Colorectal Cancer Study Group

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00291798 History of Changes
Other Study ID Numbers:	ABCSG-17
Study First Received:	February 14, 2006
Last Updated:	September 18, 2006
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Austrian Breast & Colorectal Cancer Study Group:

pilot study
exemestane
endocrinotherapy
mamma carcinoma

neoadjuvant
ABCSG
17
Mamma Carcinoma

Additional relevant MeSH terms:

Breast Neoplasms
Carcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

Exemestane
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012