Status:
COMPLETED
Neoadjuvant Endocrinotherapy of Breast Cancer (Mamma Carcinoma) With Exemestane
Lead Sponsor:
Austrian Breast & Colorectal Cancer Study Group
Collaborating Sponsors:
Pharmacia Austria GmbH
Conditions:
Breast Cancer
Eligibility:
FEMALE
59+ years
Phase:
PHASE2
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 procedure...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
End Date :
March 1 2009
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00291798
Start Date
September 1 2000
End Date
March 1 2009
Last Update
September 19 2006
Active Locations (11)
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1
Hospital of Guessing
Güssing, Burgenland, Austria, 7540
2
State Hospital Klagenfurt, Surgery
Klagenfurt, Carinthia, Austria, 9026
3
State Hospital Wolfsberg
Wolfsberg, Carinthia, Austria, 9400
4
Hospital of Wiener Neustadt
Wiener Neustadt, Lower Austria, Austria, 2700