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

Breast Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050141
• Other study ID #: CR004030
• Status: Completed
• Phase: Phase 2
• First received: November 22, 2002
• Last updated: January 31, 2013
• Start date: September 2002
• Est. completion date: January 2008

Study information

• Verified date: January 2013
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00060177
• NCT00723372

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: January 2008
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• ZARNESTRA, tipifarnib, R115777

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Countries where clinical trial is conducted

United States,  Belgium,  France,  Netherlands,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparisons between the two treatment groups will be made for patients who have achieve a confirmed Complete Response (CR) or Partial Response (PR).
Secondary	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.

External Links

•   Pharmacoepidemiologic International Longitudinal Antipsychotic Registry PILAR