Letrozole in Metastatic Breast Cancer in Combination With Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00333047
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : November 19, 2009
Information provided by:

May 31, 2006
June 2, 2006
November 19, 2009
July 2002
Not Provided
Objective response rate (complete remission, partial remission,no change, progressive disease) by clinical palpation and radiologic imaging every 3 months until disease progression
Same as current
Complete list of historical versions of study NCT00333047 on Archive Site
Time to progression and safety and toxicity during treatment
Same as current
Not Provided
Not Provided
Letrozole in Metastatic Breast Cancer in Combination With Chemotherapy
A Study of Letrozole in the Treatment of Metastatic Breast Cancer in Combination With Chemotherapy
Therapeutic interventions for patients with metastatic breast cancer are aimed at prolonging survival and improving the quality of life. The objective of this trial is to assess if an initial chemotherapy followed by an endocrine therapy leads to a longer disease-free interval as compared to chemotherapy alone.
Not Provided
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Breast Cancer
Drug: Letrozole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
Not Provided
Not Provided

Inclusion criteria

  • Histologically proven metastatic breast cancer
  • Measurable disease, patients with bone only disease are not eligible
  • Age ≥ 65 years
  • Performance status ≤ 2 (World Health Organization)
  • Estimated life expectancy under therapy of at least 3 months
  • Estrogen-/progesterone-receptor status positive or unknown
  • Signed informed consent

Exclusion criteria

  • Prior chemo- or hormone therapy for metastatic breast cancer; prior therapy with aromatase inhibitors in the adjuvant setting
  • Disease-free interval after adjuvant therapy < 1 year
  • Clinical signs of central nervous system metastases
  • Renal, bone marrow, or liver insufficiency
  • Severe coronary heart disease, cardiac insufficiency or other severe concomitant internal diseases
  • Pulmonary fibrosis/alveolitis Additional protocol-defined inclusion/exclusion criteria may apply.
Sexes Eligible for Study: Female
65 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Study Chair: Novartis Novartis
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP