A Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of Risedronate (Actonel) For Prevention Of Bone Loss In Premenopausal Women Undergoing Chemotherapy For Primary Breast Carcinoma
A Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of Risedronate (Actonel) For Prevention Of Bone Loss In Premenopausal Women Undergoing Chemotherapy For Primary Breast Carcinoma
RATIONALE: Preventing bone loss in patients who are receiving chemotherapy for breast cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without risedronate in preventing bone loss.
PURPOSE: This randomized phase III trial is studying two forms of calcium with or without risedronate to compare how well they work in preventing bone loss in premenopausal women who are receiving chemotherapy for primary stage I, stage II, stage IIIA, or stage IIIB breast cancer.
OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are stratified according to planned tamoxifen therapy (yes vs no vs undecided), planned taxane therapy (yes vs no vs undecided), time from last menses (1-3 months vs longer than 3 months to 6 months), and age (under 40 vs 40 to 49 vs 50 and over). Patients are randomized to 1 of 2 treatment arms. In both arms, treatment begins during the first month of chemotherapy and continues for 1 year in the absence of unacceptable toxicity. For more information regarding the treatment arms, please see the "Arms" section below. Questionnaires about cessation of menses, ovarian failure, and menopausal symptoms are completed at baseline, monthly during chemotherapy, at 6 months, and then at 1 and 2 years.
Patients are followed for 1 year. A summary of study goals is listed below.
Goals:
Required Characteristics
Premenopausal women
Scheduled to undergo adjuvant or neoadjuvant chemotherapy for primary breast cancer (stages I-IIIB)
≥ 18 years of age
ECOG performance status (PS) 0 or 1
Contraindications
Hypercalcemia (calcium level > 1mg/dL above UNL ≤ 6 months
Hypocalcemia (calcium level > 0.5 mg/dL below UNL ≤ 6 months
Inability to stand or sit upright for at least 30 minutes
Known swallowing disorder
Bone mineral density T score of ≤ - 2.0 at the hip or lumbar spine
History of vertebral compression fracture
Corticosteroids at doses > 5 mg daily of prednison or equivalent for > 2 weeks in the past 6 months
Previous treatment with bisphosphonates
Diseases affecting bone metabolism (hyperthyroidism, hyperparathyroidism, and hypercortisolism)
History of severe renal impairment or creatinine > 2.0 mg/dL
Malabsorption syndrome
Estrogen replacement therapy
Oral contraceptive use
Prior bilateral oophorectomy
Pregnant women
Dental extraction, root canal, or implants ≤ 3 months prior to registration or planned during study treatment
Thorton, Colorado 80229, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
Sioux City, Iowa 51101, United States
West Des Moines, Iowa 50266, United States
Wichita, Kansas 67214, United States
Ann Arbor, Michigan 48106-0995, United States
Lambertville, Michigan 48144, United States
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Allentown, Pennsylvania 18105, United States
Wilkes-Barre, Pennsylvania 18711, United States
Anderson, South Carolina 29621, United States
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