Neoadjuvant Endocrinotherapy of Breast Cancer (Mamma Carcinoma) With Exemestane

NCT ID: NCT00291798

Last Updated: 2006-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2009-03-31

Brief Summary

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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

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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

Conditions

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Breast Cancer

Keywords

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pilot study exemestane endocrinotherapy mamma carcinoma neoadjuvant ABCSG 17

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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rate of remission

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pharmacia Austria GmbH

UNKNOWN

Sponsor Role collaborator

Austrian Breast & Colorectal Cancer Study Group

NETWORK

Sponsor Role lead

Principal Investigators

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Brigitte Mlineritsch, MD

Role: STUDY_CHAIR

Austrian Breast & Colorectal Cancer Study Group

Locations

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Hospital of Guessing

Güssing, Burgenland, Austria

Site Status

State Hospital Klagenfurt, Surgery

Klagenfurt, Carinthia, Austria

Site Status

State Hospital Wolfsberg

Wolfsberg, Carinthia, Austria

Site Status

Hospital of Wiener Neustadt

Wiener Neustadt, Lower Austria, Austria

Site Status

Paracelsus Medical University Salzburg, Oncology

Salzburg, Salzburg, Austria

Site Status

Gynaegological Medical University of Graz

Graz, Styria, Austria

Site Status

Medical University of Graz, Oncology

Graz, Styria, Austria

Site Status

Hospital BHS Linz

Linz, Upper Austria, Austria

Site Status

General Hospital Linz

Linz, Upper Austria, Austria

Site Status

Medical University of Vienna, General Hospital

Vienna, Vienna, Austria

Site Status

Hanusch Hospital

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Related Links

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Other Identifiers

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ABCSG-17

Identifier Type: -

Identifier Source: org_study_id