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A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Post-menopausal Women with Hormone Receptor Positive Breast Cancer
Principal Investigator:
Haskell Kirkpatrick, M.D.
Co-Investigators:
Minal Barve, M.D.
Jaya V. Juturi, M.D.
Kristi J. McIntyre, M.D.
James F. Strauss, M.D.
Chiyu Wang, M.D.
Lalan S. Wilfong, M.D.
Purpose:
Estrogen can stimulate the growth of breast tumor cells. Aromatase Inhibitors (AIs) interfere with estrogen production. AIs almost completely block estrogen in postmenopausal women thus reducing the chances of breast cancer returning. It is not yet known whether taking hormonal therapy for more than five years will be beneficial in preventing the recurrence of hormone-responsive breast cancer.
This study is unique in that it has both a registration program and a randomized trial. The registration program will include patients who have received at least two years of tamoxifen or an AI or a combination of the two. These patients will receive letrozole for the remainder of their five-year post-surgery treatment period. Participation in the Registration Program is optional and not required for those wishing to participate in the Randomized Trial.
Patients who have completed five years of hormonal therapy are eligible for the Randomized Trial. This trial is studying the effects of letrozole vs. placebo in treating postmenopausal women who have undergone surgery for hormone-responsive breast cancer for an additional five years. Patients will be randomly assigned to one of the two treatment groups, and treatment will last for five years.
Eligibility (this is not a comprehensive list)
Optional Registration Program:
Patients must meet Randomized Trial eligibility criteria as well as one of three hormonal therapy criteria:
- 2 to 4.5 years of an AI
- 2 to 3 years of tamoxifen
- 2 to 4.5 years of a combination of tamoxifen (taken for ≤ 3 years) followed by an AI
Randomized Trial
- Postmenopausal women
- Disease-free since initial breast cancer diagnosis
- Hormonal therapy (Tamoxifen, AI or combination of the two as described above) taken for 57-63 months following diagnosis.
- No more than 6 months since completion of initial hormonal therapy.
- No sex hormonal therapy, e.g., HRT or oral contraceptives, or hormonal agents such as raloxifene for osteoporosis after enrollment.
- Able to take bisphosphonate for osteoporosis.
Final eligibility for a clinical trial is determined by the health professionals conducting the trial. For more details about the eligibility requirements for this trial, call 1-877-THR-WELL (1-877-847-9355).
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