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Letrozole in Metastatic Breast Cancer in Combination With Chemotherapy

This study has been completed.
Information provided by:
Novartis Identifier:
First received: May 31, 2006
Last updated: November 18, 2009
Last verified: November 2009
May 31, 2006
November 18, 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
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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.
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Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Breast Cancer
Drug: Letrozole
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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
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Study Chair: Novartis Novartis
November 2009

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