NCT00050141

Brief Summary

The purpose of this study is to determine if the addition of tipifarnib to standard letrozole therapy leads to a better response to treatment for your cancer in comparison to letrozole plus a placebo. Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors (FTI). It blocks proteins that make cancer cells grow.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Sep 2002

Typical duration for phase_2 breast-cancer

Geographic Reach
6 countries

23 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

September 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2002

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 28, 2002

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 1, 2013

Status Verified

January 1, 2013

Enrollment Period

3.1 years

First QC Date

November 22, 2002

Last Update Submit

January 31, 2013

Conditions

Breast Cancer

Keywords

Breast cancerZARNESTRAtipifarnibR115777Estrogen receptor positiveProgesterone receptor positiveAnti-estrogen therapy

Outcome Measures

Primary Outcomes (1)

  • Comparisons between the two treatment groups will be made for patients who have achieve a confirmed Complete Response (CR) or Partial Response (PR).

Secondary Outcomes (1)

  • Effectiveness will be assessed by time to disease progression; time to treatment failure; duration of response; clinical benefit; duration of clinical benefit; survival time. The study will include evaluations of safety and tolerability.

Interventions

ZARNESTRA, tipifarnib, R115777DRUG

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Locally advanced, inoperable loco-regionally-recurrent, or metastatic breast cancer
  • Estrogen and/or progesterone positive disease
  • Progression of disease after antiestrogen therapy
  • Measurable disease
  • Postmenopausal
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.

You may not qualify if:

  • Previous endocrine therapy, other than antiestrogen therapy
  • More than 1 prior chemotherapy regimen
  • Previous therapy with farnesyl transferase inhibitor
  • Presence of rapidly progressive, life-threatening metastases
  • Concomitant anticancer treatment
  • Other malignancy within the past 5 years
  • Symptomatic peripheral neuropathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Cleveland, Ohio, United States

Location

Unknown Facility

Fort Worth, Texas, United States

Location

Unknown Facility

Tyler, Texas, United States

Location

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Bordeaux, France

Location

Unknown Facility

Clermont-Ferrand, France

Location

Unknown Facility

Montpellier Cedex 5 N/A, France

Location

Unknown Facility

Rennes, France

Location

Unknown Facility

Saint-Herblain, France

Location

Unknown Facility

Vandœuvre-lès-Nancy, France

Location

Unknown Facility

The Hague, Netherlands

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Huddersfield, United Kingdom

Location

Unknown Facility

Leeds, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Manchester, United Kingdom

Location

Unknown Facility

Newcastle upon Tyne, United Kingdom

Location

Unknown Facility

Sutton, United Kingdom

Location

Related Publications (1)

  • Johnston SR, Semiglazov VF, Manikhas GM, Spaeth D, Romieu G, Dodwell DJ, Wardley AM, Neven P, Bessems A, Park YC, De Porre PM, Perez Ruixo JJ, Howes AJ. A phase II, randomized, blinded study of the farnesyltransferase inhibitor tipifarnib combined with letrozole in the treatment of advanced breast cancer after antiestrogen therapy. Breast Cancer Res Treat. 2008 Jul;110(2):327-35. doi: 10.1007/s10549-007-9726-1. Epub 2007 Sep 13.

    PMID: 17851757DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

tipifarnib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2002

First Posted

November 28, 2002

Study Start

September 1, 2002

Primary Completion

October 1, 2005

Study Completion

January 1, 2008

Last Updated

February 1, 2013

Record last verified: 2013-01

Locations

NL(1)FR(6)US(6)BE(2)RU(2)GB(6)