NCT00247663

Brief Summary

\- 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2005

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Last Updated

April 19, 2012

Status Verified

April 1, 2012

Enrollment Period

6 years

First QC Date

November 1, 2005

Last Update Submit

April 18, 2012

Conditions

Postmenopausal Women With Advanced Breast Cancer

Keywords

Aromatase inhibitorletrozolebreast cancer

Outcome Measures

Primary Outcomes (1)

  • Safety during treatment

Secondary Outcomes (1)

  • No secondary outcomes/objectives planned

Study Arms (1)

Letrozole

EXPERIMENTAL
Drug: Letrozole

Interventions

LetrozoleDRUG
Also known as: FEM345
Letrozole

Eligibility Criteria

Age20 Years - 74 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients which participated in double blind study

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Novartis Investigative Site

Kashiwa, Chiba, 277-8577, Japan

Location

Novartis Investigative Site

Amagasaki, Hyōgo, 660-8511, Japan

Location

Novartis Investigative Site

Hamamatsu, Shizuoka, 430-8558, Japan

Location

Novartis Investigative Site

Chuo-Ku, Tokyo, 104-0045, Japan

Location

Novartis Investigative Site

Cyuo-ku, Tokyo, 104-8560, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Novartis Investigative Site

Fukuoka, 811-4395, Japan

Location

Novartis Investigative Site

Kumamoto, 862-0909, Japan

Location

Novartis Investigative Site

Nigata-honmachi, 951-8566, Japan

Location

Novartis Investigative Site

Saitama, 338-8553, Japan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2005

First Posted

November 2, 2005

Study Start

December 1, 1999

Primary Completion

December 1, 2005

Last Updated

April 19, 2012

Record last verified: 2012-04

Locations

JP(10)