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.
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Comparisons between the two treatment groups will be made for patients who have achieve a confirmed Complete Response (CR) or Partial Response (PR).
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Food and Drug Administration
|Hinsdale, Illinois 60521|
|Miami, Florida 33176|
|Cleveland, Ohio 44195|
|Austin, Texas 78705|
|Charlotte, North Carolina|