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Letrozole in Metastatic Breast Cancer in Combination With Chemotherapy

NCT ID: NCT00333047

Last Updated: 2009-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Breast Cancer

Keywords

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Metastatic breast cancer Aromatase inhibitor Letrozole

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Letrozole

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis

Role: STUDY_CHAIR

Novartis

Locations

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Kiel, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CFEM345ADE07

Identifier Type: -

Identifier Source: org_study_id