Neoadjuvant Endocrinotherapy of Breast Cancer (Mamma Carcinoma) With Exemestane

Study Overview
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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

Official Title
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Neoadjuvant Endocrinotherapy of Mamma Carcinoma With Exemestane

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: rate of remission


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 59 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: rate of remission|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of remission |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity (WHO-grading) |  |  | 
| rate of mastectomy |  |  | 
| response of tumor subject to HER2-status |  |  | 
| collection of disease free survival and overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pilot study, exemestane, endocrinotherapy, mamma carcinoma, neoadjuvant, ABCSG, 17