Breast Cancer
Conditions
Keywords
pilot study, exemestane, endocrinotherapy, mamma carcinoma, neoadjuvant, ABCSG, 17
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
Interventions
PROCEDURErate of remission
Sponsors
Pharmacia Austria GmbH
Austrian Breast & Colorectal Cancer Study Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
59 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of remission | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity (WHO-grading) | — |
| rate of mastectomy | — |
| response of tumor subject to HER2-status | — |
| collection of disease free survival and overall survival | — |
Countries
Austria
Outcome results
None listed