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

NCT ID: NCT00050141

Last Updated: 2013-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2008-01-31

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

ZARNESTRA, tipifarnib, R115777

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Locations

Miami, Florida, United States

Chicago, Illinois, United States

Durham, North Carolina, United States

Cleveland, Ohio, United States

Fort Worth, Texas, United States

Tyler, Texas, United States

Brussels, , Belgium

Leuven, , Belgium

Bordeaux, , France

Clermont-Ferrand, , France

Montpellier Cedex 5 N/A, , France

Rennes, , France

Saint-Herblain, , France

Vandœuvre-lès-Nancy, , France

The Hague, , Netherlands

Moscow, , Russia

Saint Petersburg, , Russia

Huddersfield, , United Kingdom

Leeds, , United Kingdom

London, , United Kingdom

Manchester, , United Kingdom

Newcastle upon Tyne, , United Kingdom

Sutton, , United Kingdom

Countries

United States; Belgium; France; Netherlands; Russia; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 17851757 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=397&filename=CR014707_CSR.pdf

Pharmacoepidemiologic International Longitudinal Antipsychotic Registry PILAR

Other Identifiers

CR004030

Identifier Type: -

Identifier Source: org_study_id

NCT00060177

Identifier Type: -

Identifier Source: nct_alias

NCT00723372

Identifier Type: -

Identifier Source: nct_alias