Letrozole in 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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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Kiel, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

letrozole

Drug

Primary outcomes

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

Secondary outcomes

Time to progression and safety and toxicity during treatment

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Study of Letrozole in the Treatment of Metastatic Breast Cancer in Combination With Chemotherapy

Important dates

Study start: 2002
First posted: Jun 2, 2006
Registry last updated: Nov 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed