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Neoadjuvant Endocrinotherapy of Breast Cancer (Mamma Carcinoma) With Exemestane

This study has been completed.
Sponsor:
Collaborator:
Pharmacia Austria GmbH
Information provided by:
Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00291798
First received: February 14, 2006
Last updated: September 18, 2006
Last verified: February 2006
History of Changes

February 14, 2006
September 18, 2006
September 2000
Not Provided
rate of remission
Same as current
Complete list of historical versions of study NCT00291798 on ClinicalTrials.gov Archive Site
  • Toxicity (WHO-grading)
  • rate of mastectomy
  • response of tumor subject to HER2-status
  • collection of disease free survival and overall survival
  • Toxicity (WHO-grading)
  • rate of mastectomy
  • response of tumor subject to HER2-status
  • colletion of disease free survival and overall survival
Not Provided
Not Provided
 
Neoadjuvant Endocrinotherapy of Breast Cancer (Mamma Carcinoma) With Exemestane
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.

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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Procedure: rate of remission
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
March 2009
Not Provided

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
Female
59 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00291798
ABCSG-17
Not Provided
Not Provided
Austrian Breast & Colorectal Cancer Study Group
Pharmacia Austria GmbH
Study Chair: Brigitte Mlineritsch, MD Austrian Breast & Colorectal Cancer Study Group
Austrian Breast & Colorectal Cancer Study Group
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP