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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
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

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

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
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Please refer to this study by its identifier: NCT00333047

Kiel, Germany
Sponsors and Collaborators
Study Chair: Novartis Novartis
  More Information Identifier: NCT00333047     History of Changes
Other Study ID Numbers: CFEM345ADE07 
Study First Received: May 31, 2006
Last Updated: November 18, 2009
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Metastatic breast cancer
Aromatase inhibitor

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
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 processed this record on October 26, 2016