NCT00171847

Brief Summary

Phase IV trial to investigate the effect of the combination of Letrozole with trastuzumab in metastatic breast cancer patients

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Last Updated

March 31, 2010

Status Verified

March 1, 2010

Enrollment Period

5.6 years

First QC Date

September 13, 2005

Last Update Submit

March 30, 2010

Conditions

Metastatic Breast Cancer

Keywords

Breast cancerMetastaticTrastuzumabLetrozole

Outcome Measures

Primary Outcomes (1)

  • Time to progression as assessed by clinical palpation and radiologic imaging every 3 months

    3 months

Secondary Outcomes (4)

  • Objective response rate/Clinical Benefit rate

    3 months

  • Time to treatment failure

    3 months

  • Duration of response/clinical benefit during treatment

    3 months

  • Overall survival

    3 months

Study Arms (3)

A - HER-2 +ve patients with Femara alone

EXPERIMENTAL
Drug: Letrozole

B - HER-2 +ve patients with Femara + Herceptin

EXPERIMENTAL
Drug: Trastuzumab plus Letrozole

C - HER-2 -ve patients with Femara alone

EXPERIMENTAL
Drug: Letrozole

Interventions

LetrozoleDRUG
A - HER-2 +ve patients with Femara alone
Trastuzumab plus LetrozoleDRUG
B - HER-2 +ve patients with Femara + Herceptin

Eligibility Criteria

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

You may qualify if:

  • Postmenopausal
  • Her-2 overexpression and ER and/or PgR positive
  • Metastatic Breast Cancer

You may not qualify if:

  • Previous treatment with trastuzumab
  • Significant Liver or renal impairment
  • Erbb2 negative and/or ER and PgR negative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Tübingen, Germany

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

LetrozoleTrastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmeceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

March 1, 2003

Primary Completion

October 1, 2008

Last Updated

March 31, 2010

Record last verified: 2010-03

Locations

DE(1)