NCT00333047

Brief Summary

Therapeutic interventions for patients with metastatic breast cancer are aimed at prolonging survival and improving the quality of life. The objective of this trial is to assess if an initial chemotherapy followed by an endocrine therapy leads to a longer disease-free interval as compared to chemotherapy alone.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

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

July 1, 2002

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2006

Completed
Last Updated

November 19, 2009

Status Verified

November 1, 2009

First QC Date

May 31, 2006

Last Update Submit

November 18, 2009

Conditions

Metastatic Breast Cancer

Keywords

Metastatic breast cancerAromatase inhibitorLetrozole

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (complete remission, partial remission,no change, progressive disease) by clinical palpation and radiologic imaging every 3 months until disease progression

Secondary Outcomes (1)

  • Time to progression and safety and toxicity during treatment

Interventions

LetrozoleDRUG

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Histologically proven metastatic breast cancer
  • Measurable disease, patients with bone only disease are not eligible
  • Age ≥ 65 years
  • Performance status ≤ 2 (World Health Organization)
  • Estimated life expectancy under therapy of at least 3 months
  • Estrogen-/progesterone-receptor status positive or unknown
  • Signed informed consent

You may not qualify if:

  • Prior chemo- or hormone therapy for metastatic breast cancer; prior therapy with aromatase inhibitors in the adjuvant setting
  • Disease-free interval after adjuvant therapy \< 1 year
  • Clinical signs of central nervous system metastases
  • Renal, bone marrow, or liver insufficiency
  • Severe coronary heart disease, cardiac insufficiency or other severe concomitant internal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kiel, Germany

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

    Novartis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 31, 2006

First Posted

June 2, 2006

Study Start

July 1, 2002

Last Updated

November 19, 2009

Record last verified: 2009-11

Locations

DE(1)