Neoadjuvant Endocrinotherapy of Breast Cancer (Mamma Carcinoma) With Exemestane
Information source: Austrian Breast & Colorectal Cancer Study Group
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: rate of remission (Procedure)
Phase: Phase 2
Status: Completed
Sponsored by: Austrian Breast & Colorectal Cancer Study Group Official(s) and/or principal investigator(s):
Brigitte Mlineritsch, MD, Study Chair, Affiliation: ABCSG
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.
Clinical Details
Official title: Neoadjuvant Endocrinotherapy of Mamma Carcinoma With Exemestane
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: rate of remission
Secondary outcome: Toxicity (WHO-grading)rate of mastectomy response of tumor subject to HER2-status collection of disease free survival and overall survival
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
Minimum age: 59 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Paracelsus Medical University Salzburg, Oncology, Salzburg 5020, Austria
Medical University of Vienna, General Hospital, Vienna 1090, Austria
Medical University of Vienna, General Hospital, Vienna 1090, Austria
Medical University of Vienna, General Hospital, Vienna 1090, Austria
Hanusch Hospital, Vienna 1140, Austria
Hospital of Guessing, Guessing, 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
Gynaegological Medical University of Graz, Graz, Styria 8036, Austria
Medical University of Graz, Oncology, Graz, Styria 8036, Austria
General Hospital Linz, Linz, Upper Austria 4020, Austria
Hospital BHS Linz, Linz, Upper Austria 4010, Austria
Additional Information
Starting date: September 2000
Ending date: March 2009
Last updated: September 18, 2006
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