NCT00329940

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

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

November 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

2.2 years

First QC Date

May 23, 2006

Last Update Submit

February 22, 2017

Conditions

Breast Cancer

Keywords

Letrozolebreast cancercritical musculoskeletalpostmenopausalrheumatologic tolerance

Outcome Measures

Primary Outcomes (1)

  • To evaluate the rheumatological tolerability of letrozole 2.5 mg/day in patients treated with anastrozole 1 mg/day

    at 1, 3 and 6 months of letrozole treatment

Secondary Outcomes (2)

  • To determine the causes of discontinuation

    at 1, 3 and 6 months of letrozole treatment

  • To determine how long letrozole treatment is maintained

    at 1, 3 and 6 months of letrozole treatment

Study Arms (1)

Letrozole

EXPERIMENTAL

to evaluate the rheumatological tolerability of Femara

Drug: Letrozole

Interventions

LetrozoleDRUG
Also known as: Femara
Letrozole

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Saint-Cloud, France

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 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2006

First Posted

May 25, 2006

Study Start

November 1, 2005

Primary Completion

January 1, 2008

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

FR(1)