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Letrozole in Metastatic Breast Cancer in Combination With Chemotherapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00333047
First Posted: June 2, 2006
Last Update Posted: November 19, 2009
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.
Information provided by:
Novartis
  Purpose
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.

Condition Intervention Phase
Metastatic Breast Cancer Drug: Letrozole Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Letrozole in the Treatment of Metastatic Breast Cancer in Combination With Chemotherapy

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Objective response rate (complete remission, partial remission,no change, progressive disease) by clinical palpation and radiologic imaging every 3 months until disease progression

Secondary Outcome Measures:
  • Time to progression and safety and toxicity during treatment

Estimated Enrollment: 24
Study Start Date: July 2002
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333047


Locations
Germany
Kiel, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

ClinicalTrials.gov Identifier: NCT00333047     History of Changes
Other Study ID Numbers: CFEM345ADE07
First Submitted: May 31, 2006
First Posted: June 2, 2006
Last Update Posted: November 19, 2009
Last Verified: November 2009

Keywords provided by Novartis:
Metastatic breast cancer
Aromatase inhibitor
Letrozole

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs