Safety and Rheumatologic Tolerability of Letrozole in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer

NCT ID: NCT00329940

Last Updated: 2017-02-24

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

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Brief Summary

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The purpose of this study is to assess rheumatologic tolerability of letrozole in postmenopausal patients with hormone receptor positive breast cancer having discontinued anastrozole adjuvant treatment due to musculoskeletal disorders.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Letrozole

to evaluate the rheumatological tolerability of Femara

Group Type EXPERIMENTAL

Letrozole

Intervention Type DRUG

Interventions

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Letrozole

Intervention Type DRUG

Other Intervention Names

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Femara

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal women receiving anastrozole adjuvant therapy for hormone receptor positive breast cancer who want to interrupt the treatment because of severe rheumatologic adverse events
* Polymorphonuclear neutrophils (PNN) ≥ 1200/mm3, platelets ≥ 100000/mm3, hemoglobin (Hb) ≥ 10 g/dL
* Bilirubin ≤ 30 μmol, SGOT/SGPT \< 3N
* Fully signed informed consent

Exclusion Criteria

* Pain due to bone fracture
* Metastatic disease
* Hormone therapy other than anastrozole
* Incapacitating or uncontrolled concomitant disease that could hamper patient's quality of life
* Hypersensitivity to letrozole or its components
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Saint-Cloud, , France

Site Status

Countries

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France

Other Identifiers

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CFEM345DFR04

Identifier Type: -

Identifier Source: org_study_id

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