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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00050141

Run by

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

People needed

121

Starts

2002-09-01

Expected to finish

2008-01-01

Last updated by the study team

2013-02-01

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Miami, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Durham, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Fort Worth, Texas, United States
• Study site — Tyler, Texas, United States
• Study site — Brussels, Belgium
• Study site — Leuven, Belgium
• Study site — Bordeaux, France
• Study site — Clermont-Ferrand, France
• Study site — Montpellier Cedex 5 N/A, France
• Study site — Rennes, France
• Study site — Saint-Herblain, France
• Study site — Vandœuvre-lès-Nancy, France
• Study site — The Hague, Netherlands
• Study site — Moscow, Russia
• Study site — Saint Petersburg, Russia
• Study site — Huddersfield, United Kingdom
• Study site — Leeds, United Kingdom
• Study site — London, United Kingdom
• Study site — Manchester, United Kingdom
• Study site — Newcastle upon Tyne, United Kingdom
• Study site — Sutton, United Kingdom

Full record on ClinicalTrials.gov

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