Extension Study of 1.0mg Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

NCT ID: NCT00247663

Last Updated: 2012-04-19

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

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Brief Summary

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\- To investigate the safety of letrozole monotherapy at a dose 1.0 mg/day or fadrozole monotherapy at a dose 2.0mg in Japanese postmenopausal patients with advanced breast cancer which participated in double blind study.

Detailed Description

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Conditions

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Postmenopausal Women With Advanced 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

Group Type EXPERIMENTAL

Letrozole

Intervention Type DRUG

Interventions

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Letrozole

Intervention Type DRUG

Other Intervention Names

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FEM345

Eligibility Criteria

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Inclusion Criteria

\- Patients which participated in double blind study

Exclusion Criteria

* Patients with intolerable toxicity.
* Patients which confirmed progressive disease during double blind study.
* Patients which have received concurrent anti-cancer therapy during double blind study.
Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chugai Pharmaceutical

INDUSTRY

Sponsor Role collaborator

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

Kashiwa, Chiba, Japan

Site Status

Novartis Investigative Site

Amagasaki, Hyōgo, Japan

Site Status

Novartis Investigative Site

Hamamatsu, Shizuoka, Japan

Site Status

Novartis Investigative Site

Chuo-Ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Cyuo-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Shinjuku-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Fukuoka, , Japan

Site Status

Novartis Investigative Site

Kumamoto, , Japan

Site Status

Novartis Investigative Site

Nigata-honmachi, , Japan

Site Status

Novartis Investigative Site

Saitama, , Japan

Site Status

Countries

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Japan

Other Identifiers

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CFEM345 1601

Identifier Type: -

Identifier Source: org_study_id

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