Neoadjuvant Endocrinotherapy of Breast Cancer (Mamma Carcinoma) With Exemestane

Austrian Breast & Colorectal Cancer Study Group

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Procedure: rate of remission

Study type

Interventional

Funder types

NETWORK

Other

Identifiers

NCT00291798

ABCSG-17

Details and patient eligibility

About

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.

Full 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

Sex

Female

Ages

59+ years old

Volunteers

No Healthy Volunteers

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