Clinical trial NCT00291798: Neoadjuvant Endocrinotherapy of Breast Cancer (Mamma Carcinoma) With Exemestane
Official title: Neoadjuvant Endocrinotherapy of Mamma Carcinoma With Exemestane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: pilot study
exemestane
endocrinotherapy
mamma carcinoma
neoadjuvant
ABCSG
17
Lead sponsor: Austrian Breast & Colorectal Cancer Study Group
Sponsor class: NETWORK
Collaborators: name: Pharmacia Austria GmbH
First posted: 2006-02-15
Enrollment: 98
Sex: FEMALE
Minimum age (years): 59
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: rate of remission
Secondary outcomes:
measure: Toxicity (WHO-grading)
measure: rate of mastectomy
measure: response of tumor subject to HER2-status
measure: collection of disease free survival and overall survival
Other outcomes:
Locations:
city: Guessing
country: Austria
facility: Hospital of Guessing
state: Burgenland
city: Klagenfurt
country: Austria
facility: State Hospital Klagenfurt, Surgery
state: Carinthia
city: Wolfsberg
country: Austria
facility: State Hospital Wolfsberg
state: Carinthia
city: Wiener Neustadt
country: Austria
facility: Hospital of Wiener Neustadt
state: Lower Austria
city: Graz
country: Austria
facility: Gynaegological Medical University of Graz
state: Styria
city: Graz
country: Austria
facility: Medical University of Graz, Oncology
state: Styria
city: Linz
country: Austria
facility: Hospital BHS Linz
state: Upper Austria
city: Linz
country: Austria
facility: General Hospital Linz
state: Upper Austria
city: Salzburg
country: Austria
facility: Paracelsus Medical University Salzburg, Oncology
city: Vienna
country: Austria
facility: Medical University of Vienna, General Hospital
city: Vienna
country: Austria
facility: Hanusch Hospital
Study officials:
affiliation: Austrian Breast & Colorectal Cancer Study Group
name: Brigitte Mlineritsch, MD
role: STUDY_CHAIR
References: