Study of Letrozole Plus Tipifarnib or Placebo in the Treatment of Advanced Breast Cancer

January 31, 2013 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Randomised, Blinded, Phase 2 Study of Letrozole Plus the Farnesyl Transferase Inhibitor ZARNESTRA TM (R115777) and Letrozole Plus Placebo in the Treatment of Advanced Breast Cancer After Antiestrogen Therapy.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This clinical study involves two groups of patients with advanced breast cancer. One group (2/3rds of all the patients) will be taking tipifarnib in combination with another anticancer drug called letrozole, and the other group (1/3rd of all the patients) will be taking letrozole plus a placebo (an inactive substance given in the same form as a real drug). The assignment to one of these two groups will be by chance (like flipping a coin). Unless the need arises, neither the patient nor the study staff will know whether the patient is receiving tipifarnib with the letrozole. Comparisons between the two groups will be made for patients who have achieve a confirmed Complete Response (CR) or Partial Response (PR). The interval between the date of randomization and the earliest date of disease progression will also be assessed. The study will include evaluations of safety and tolerability. Patients should expect their participation in this trial to last a minimum of 4 to 8 weeks. Their participation could continue for several months or beyond a year, depending on how their disease responds to the treatment. After completing study treatment, patients will be asked to attend for an End of Treatment visit and then a posttreatment Follow-up visit 4 to 6 weeks after stopping the medication. Patients will be randomly assigned to treatment with either 2.5 mg letrozole once daily plus placebo to match tipifarnib twice daily, or 2.5 mg letrozole once daily plus 300 mg tipifarnib twice daily. Both tipifranib and matching placebo will be given in 28-day cycles of 21 days of treatment followed by 7 days rest. All patients will receive continuous treatment with letrozole.

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium
      • Leuven, Belgium
  • France
      • Bordeaux Cedex, France
      • Clermont Ferrand Cedex 1, France
      • Montpellier Cedex 5 N/A, France
      • Rennes Cedex, France
      • Saint Herblain, France
      • Vandoeuvre Les Nancy, France
  • Netherlands
      • Den Haag, Netherlands
  • Russian Federation
      • Moscow, Russian Federation
      • Moscow N/A, Russian Federation
      • St Petersburg, Russian Federation
      • St Petersburg N/A, Russian Federation
  • United Kingdom
      • Huddersfield, United Kingdom
      • Leeds, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Newcastle Upon Tyne, United Kingdom
      • Sutton, United Kingdom
  • United States
    • Florida
      • Miami, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • North Carolina
      • Durham, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
    • Texas
      • Fort Worth, Texas, United States
      • Tyler, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (ACTUAL)

October 1, 2005

Study Completion (ACTUAL)

January 1, 2008

Study Registration Dates

First Submitted

November 22, 2002

First Submitted That Met QC Criteria

November 27, 2002

First Posted (ESTIMATE)

November 28, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2013

Last Update Submitted That Met QC Criteria

January 31, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR004030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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