Neoadjuvant Endocrinotherapy of Breast Cancer (Mamma Carcinoma) With Exemestane
1 other identifier
interventional
98
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 breast-cancer
Started Sep 2000
Longer than P75 for phase_2 breast-cancer
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2000
CompletedFirst Submitted
Initial submission to the registry
February 14, 2006
CompletedFirst Posted
Study publicly available on registry
February 15, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedSeptember 19, 2006
February 1, 2006
February 14, 2006
September 18, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of remission
Secondary Outcomes (4)
Toxicity (WHO-grading)
rate of mastectomy
response of tumor subject to HER2-status
collection of disease free survival and overall survival
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Hospital of Guessing
Güssing, Burgenland, 7540, Austria
State Hospital Klagenfurt, Surgery
Klagenfurt, Carinthia, 9026, Austria
State Hospital Wolfsberg
Wolfsberg, Carinthia, 9400, Austria
Hospital of Wiener Neustadt
Wiener Neustadt, Lower Austria, 2700, Austria
Paracelsus Medical University Salzburg, Oncology
Salzburg, Salzburg, 5020, Austria
Gynaegological Medical University of Graz
Graz, Styria, 8036, Austria
Medical University of Graz, Oncology
Graz, Styria, 8036, Austria
Hospital BHS Linz
Linz, Upper Austria, 4010, Austria
General Hospital Linz
Linz, Upper Austria, 4020, Austria
Medical University of Vienna, General Hospital
Vienna, Vienna, 1090, Austria
Hanusch Hospital
Vienna, Vienna, 1140, Austria
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Brigitte Mlineritsch, MD
Austrian Breast & Colorectal Cancer Study Group
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
February 14, 2006
First Posted
February 15, 2006
Study Start
September 1, 2000
Study Completion
March 1, 2009
Last Updated
September 19, 2006
Record last verified: 2006-02