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Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

NCT ID: NCT00332852

Last Updated: 2017-02-23

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

655 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Brief Summary

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This is a prospective open-label one-arm phase III trial designed to evaluate the safety and efficacy of letrozole 2.5 mg administered orally daily for 24 months as adjuvant therapy in postmenopausal patients with primary breast cancer.

This trial is not recruiting patients in the United States.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Letrozole

Group Type EXPERIMENTAL

Letrozole

Intervention Type DRUG

2.5 mg/day - oraly

Interventions

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Letrozole

2.5 mg/day - oraly

Intervention Type DRUG

Other Intervention Names

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Femara FEM345

Eligibility Criteria

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Inclusion Criteria

* Compliant postmenopausal women with primary operable breast cancer after complete surgery and suitable for endocrine treatment
* Nodal status negative or positive
* Good Health status 0-2 (Eastern Cooperative Oncology Group)
* Estrogen- and/or progesterone-receptor positive
* Adequate marrow, kidney and liver function

Exclusion Criteria

* Metastatic or inflammatory breast cancer
* Patients with previous or concomitant cancers (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell skin cancer or in situ cancer of the cervix. Patients with other previous cancers must have been disease-free for at least 5 years and Patients with uncontrolled, non-malignant systemic cardiovascular, kidney, and liver diseases.
* Current/active dental problems including infection of the teeth or jawbone, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures.
* Recent (within 6 weeks) or planned dental or jaw surgery
* Patients with primary overactive parathyroid
* Patients with a known hypersensitivity to zoledronic acid or other bisphosphonates.
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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Novartis Pharmaceuticals

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmeceuticals

Locations

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Novartis Investigative Site

Albstadt, , Germany

Site Status

Schorndorf

Augsburg, , Germany

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Novartis Investigative Site

Bamberg, , Germany

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Novartis Investigative Site

Berlin, , Germany

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Novartis Investigative Site

Bonn, , Germany

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Novartis Investigative Site

Bottrop, , Germany

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Novartis Investigative Site

Braunschweig, , Germany

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Novartis Investigative site

Celle, , Germany

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Chemnitz, , Germany

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Novartis Investigative Site

Dortmund, , Germany

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Frankfurt, , Germany

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Fulda, , Germany

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Novartis Investigative Site

Gera, , Germany

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Novartis Investigative Site

Gütersloh, , Germany

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Hamburg, , Germany

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Hamelin, , Germany

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Hanover, , Germany

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Herne, , Germany

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Holzminden, , Germany

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Höxter, , Germany

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Ilsede, , Germany

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Itzehoe, , Germany

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Jena, , Germany

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Karlsruhe, , Germany

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Kempten, , Germany

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Novartis Investigative Site

Konigs, , Germany

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Schorndorf

Konstanz, , Germany

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Novartis Investigative Site

Lich, , Germany

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Novartis Investigative Site

Lohsa/Weisskollm, , Germany

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Novartis Investigative Site

Ludwigsburg, , Germany

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Novartis Investigative Site

Memmingen, , Germany

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Mühlhausen, , Germany

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München, , Germany

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Münster, , Germany

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Neumünster, , Germany

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Neunkirchen, , Germany

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Novartis Investigative Site

Offenburg, , Germany

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Pforzheim, , Germany

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Rendsburg, , Germany

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Saarbrücken, , Germany

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Saarlouis, , Germany

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Novartis Investigative Site

Saint Wendel, , Germany

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Novartis Investigative Site

Salzgitter, , Germany

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Novartis Investigative Site

Schorndorf, , Germany

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Novartis Investigative Site

Schwetzingen, , Germany

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Novartis Investigative Site

Starnberg, , Germany

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Novartis Investigative Site

Stuttgart, , Germany

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Novartis Investigative Site

Tuttlingen, , Germany

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Novartis Investigative Site

Ulm, , Germany

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Novartis Investigative Site

Walsrode, , Germany

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Novartis Investigative Site

Westerburg, , Germany

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Novartis Investigative Site

Wiesbaden, , Germany

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Novartis Investigative Site

Wolfsburg, , Germany

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Countries

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Germany

Other Identifiers

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CFEM345DDE10

Identifier Type: -

Identifier Source: org_study_id

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