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Neoadjuvant Endocrinotherapy of Mamma Carcinoma With Exemestane

Phase 2
59 Years
Not Enrolling
Breast Cancer

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Trial Information

Neoadjuvant Endocrinotherapy of Mamma Carcinoma With Exemestane

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

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

rate of remission

Principal Investigator

Brigitte Mlineritsch, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Austrian Breast & Colorectal Cancer Study Group


Austria: Federal Ministry for Health and Women

Study ID:




Start Date:

September 2000

Completion Date:

March 2009

Related Keywords:

  • Breast Cancer
  • pilot study
  • exemestane
  • endocrinotherapy
  • mamma carcinoma
  • neoadjuvant
  • 17
  • Mamma Carcinoma
  • Breast Neoplasms
  • Carcinoma