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OpenTrials
Completed

NCT Number: NCT00291798

Neoadjuvant Endocrinotherapy of Breast Cancer (Mamma Carcinoma) With Exemestane

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

59 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hospital of Guessing, Guessing, Burgenland, Austria

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rate of remission

Procedure

Primary outcomes

  1. rate of remission

Secondary outcomes

  1. Toxicity (WHO-grading)

  2. rate of mastectomy

  3. response of tumor subject to HER2-status

  4. collection of disease free survival and overall survival

Sponsors and collaborators

Lead sponsor

Austrian Breast & Colorectal Cancer Study Group

Network

Collaborators

  • Pharmacia Austria GmbH

Registry information

Official study title

Neoadjuvant Endocrinotherapy of Mamma Carcinoma With Exemestane

Important dates

Study start
2000
Study completion
2009
First posted
Feb 15, 2006
Registry last updated
Sep 19, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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