Neoadjuvant Endocrinotherapy of Breast Cancer (Mamma Carcinoma) With Exemestane
This study has been completed.
Sponsor:
Austrian Breast & Colorectal Cancer Study Group
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
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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 2 |
| 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
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 |
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:
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 May 21, 2013