Neoadjuvant Endocrinotherapy of Breast Cancer (Mamma Carcinoma) With Exemestane

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00291798
• Lead Sponsor: Austrian Breast & Colorectal Cancer Study Group

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.

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

Study Timeline

• Study Start: 2000-09
• Status Verified: 2006-02
• Study First Submitted: 2006-02-14
• Study First Submitted QC: 2006-02-14
• Study First Posted: 2006-02-15
• Last Update Submitted: 2006-09-18
• Last Update Posted: 2006-09-19
• Study Completion: 2009-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
rate of remission

Secondary Outcome Measures

Name	Time	Method
collection of disease free survival and overall survival
Toxicity (WHO-grading)
rate of mastectomy
response of tumor subject to HER2-status

Trial Locations

Locations (11)

Hospital of Guessing; 🇦🇹 Guessing, Burgenland, Austria

Hospital of Wiener Neustadt; 🇦🇹 Wiener Neustadt, Lower Austria, Austria

Gynaegological Medical University of Graz; 🇦🇹 Graz, Styria, Austria

Medical University of Graz, Oncology; 🇦🇹 Graz, Styria, Austria

Hospital BHS Linz; 🇦🇹 Linz, Upper Austria, Austria

General Hospital Linz; 🇦🇹 Linz, Upper Austria, Austria

Paracelsus Medical University Salzburg, Oncology; 🇦🇹 Salzburg, Austria

Hanusch Hospital; 🇦🇹 Vienna, Austria

State Hospital Wolfsberg; 🇦🇹 Wolfsberg, Carinthia, Austria

State Hospital Klagenfurt, Surgery; 🇦🇹 Klagenfurt, Carinthia, Austria

Medical University of Vienna, General Hospital; 🇦🇹 Vienna, Austria