Trials Sponsors Conditions Drugs Pricing

Conditions

Postmenopausal Women With Advanced Breast Cancer

Keywords

Aromatase inhibitorletrozolebreast cancer

Outcome Measures

Primary Outcomes (2)

Safety during treatment
Until disease progression or appearance of unacceptable toxicity whichever comes first
Response Rate during treatment
Until disease progression or appearance of unacceptable toxicity whichever comes first

Secondary Outcomes (6)

Clinical Benefit Rate during treatment
Until disease progression or appearance of unacceptable toxicity whichever comes first
Duration of response
from the first date of response confirmed and the last date of response confirmed
Time to progression
from the first date of response confirmed and the last date of response confirmed
Time to treatment failure
from the date of study initiation and the date of disease progression confirmed or discontinuation other than disease progression
Plasma drug concentration from baseline, every 4 weeks until 28 weeks, at 40 weeks and at 52 weeks
Baseline, 52 weeks
+1 more secondary outcomes

Study Arms (1)

Letrozole

EXPERIMENTAL

Drug: Letrozole

Interventions

LetrozoleDrug

Also known as: FEM345

Letrozole

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age20 Years - 79 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with histologically or cytologically documented breast cancer
Patients with progressive breast cancer (advanced breast cancer, locoregional recurrence not operative, or metastatic breast cancer)

Sponsors & Collaborators

Chugai Pharmaceutical
Industrycollaborator
Novartis Pharmaceuticals
Industrylead

Study Sites (24)

Novartis Investigative Site

Nagoya, Aichi-ken, 464-8681, Japan

Novartis Investigative Site

Nagoya, Aichi-ken, 465-0024, Japan

Novartis Investigative Site

Kashiwa, Chiba, 277-8577, Japan

Novartis Investigative Site

Matsuyama, Ehime, 791-0280, Japan

Novartis Investigative Site

Fukuoka, Fukuoka, 811-1395, Japan

Novartis Investigative Site

Fukushima, Fukushima, 960-1295, Japan

Novartis Investigative Site

kooriyama, Fukushima, 963-8501, Japan

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

Enrollment

47 participants (actual enrollment reported by the registry).

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

October 9, 2005

First Posted

October 12, 2005

Study Start

March 2004

Date type not reported

This date has not been verified as actual or estimated.

Study of Safety and Efficacy of Letrozole Monotherapy as Second-line Endocrine Therapy in Postmenopausal Patients With Advanced Breast Cancer Who Received Previous Anti-estrogen Treatment

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Study Arms (1)

Letrozole

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (24)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Study Arms (1)

Letrozole

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (24)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations