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Letrozole in Metastatic Breast Cancer in Combination With Chemotherapy

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00333047
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 ClinicalTrials.gov 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
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
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.
Female
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00333047
CFEM345ADE07
Not Provided
Not Provided
Novartis
Not Provided
Study Chair: Novartis Novartis
Novartis
November 2009

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