Combined Estrogen Blockade of the Breast With Exemestane and Raloxifene in Estrogen Receptor (ER)-Negative and Progesterone Receptor (PR)-Negative Postmenopausal Women With a History of Breast Cancer Who Have No Clinical Evidence of Disease
- Evaluate the clinical safety and toxicity of raloxifene in combination with exemestane
in postmenopausal women with a history of stage 0 (ductal carcinoma in situ), I, II, or
III breast cancer who have no clinical evidence of disease after completion of all
planned adjuvant therapy.
- Evaluate the effects of this combination on plasma concentrations of estrogens, markers
of bone turnover and bone mineral density, serum lipoprotein profile, and quality of
life in this patient population.
- Determine the pharmacokinetics and the pharmacodynamics of this combination in these
- Determine the feasibility of using mammography and breast MRI to assess the effects of
this drug combination on radiographic breast density.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral raloxifene once a day for 2 weeks.
- Arm II: Patients receive oral exemestane once a day for 2 weeks. After 2 weeks of
single agent therapy, all patients receive combination therapy with oral raloxifene and
oral exemestane once a day for 1 year in the absence of unacceptable toxicity or
disease recurrence. At the end of 1 year, patients may continue receiving raloxifene
alone or raloxifene plus exemestane for a maximum duration of 5 years.
Quality of life is assessed at baseline, and then at 3, 6, and 12 months. Patients who
continue treatment after 1 year have quality of life assessed at 24, 36, 48, and 60 months.
Patients are followed every 3 months for the first year. Patients who continue treatment
after 1 year are followed every 6 months through the fifth year.
PROJECTED ACCRUAL: A total of 30 patients (15 per arm) will be accrued for this study.
Allocation: Randomized, Primary Purpose: Prevention
Maura N. Dickler, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|