Neoadjuvant Endocrinotherapy of Breast Cancer (Mamma Carcinoma) With Exemestane

Breast Cancer Clinical Trial

Official title:

Neoadjuvant Endocrinotherapy of Mamma Carcinoma With Exemestane

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291798
• Other study ID #: ABCSG-17
• Status: Completed
• Phase: Phase 2
• First received: February 14, 2006
• Last updated: September 18, 2006
• Start date: September 2000
• Est. completion date: March 2009

Study information

• Verified date: February 2006
• Source: Austrian Breast & Colorectal Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 59 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• rate of remission

Locations

Country	Name	City	State
Austria	Gynaegological Medical University of Graz	Graz	Styria
Austria	Medical University of Graz, Oncology	Graz	Styria
Austria	Hospital of Guessing	Guessing	Burgenland
Austria	State Hospital Klagenfurt, Surgery	Klagenfurt	Carinthia
Austria	General Hospital Linz	Linz	Upper Austria
Austria	Hospital BHS Linz	Linz	Upper Austria
Austria	Paracelsus Medical University Salzburg, Oncology	Salzburg
Austria	Hanusch Hospital	Vienna
Austria	Medical University of Vienna, General Hospital	Vienna
Austria	Hospital of Wiener Neustadt	Wiener Neustadt	Lower Austria
Austria	State Hospital Wolfsberg	Wolfsberg	Carinthia

Sponsors (2)

Lead Sponsor	Collaborator
Austrian Breast & Colorectal Cancer Study Group	Pharmacia Austria GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of remission
Secondary	Toxicity (WHO-grading)
Secondary	rate of mastectomy
Secondary	response of tumor subject to HER2-status
Secondary	collection of disease free survival and overall survival

External Links

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