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

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Estrogens; Letrozole; Tipifarnib

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.