Does Adjuvant Zoledronic Acid Reduce Recurrence in Patients With High Risk Localized Breast Cancer?

Date de début de l'étude : 1 août 2003

DISEASE CHARACTERISTICS: * Diagnosis of primary breast cancer, meeting 1 of the following staging criteria: * Stage II * Stage III * T stage ≥ T1 * Receiving OR scheduled to receive chemotherapy and/or endocrine therapy * For patients receiving neoadjuvant therapy * Tumor \> 5 cm (T3), features of locally advanced disease (T4), OR biopsy-proven lymph node involvement (N1) * Scheduled to proceed to definitive surgery and/or radical radiotherapy with curative intent within 6 months of starting neoadjuvant therapy * No more than 30 days between initiation of neoadjuvant therapy and start of study drug * For patients receiving adjuvant therapy * Must have undergone complete primary tumor resection and treatment of axillary lymph nodes\* * Must have lymph node involvement * No prior neoadjuvant therapy\*\* * No more than 60 days since prior definitive surgery NOTE: \*Patients whose treatment plan includes further primary tumor resection and/or treatment of the axillary lymph nodes (e.g., clearance or radiotherapy) with curative intent after completion of chemotherapy are eligible provided the treatment is completed within 9 months of study entry NOTE: \*\*Preoperative endocrine therapy with a duration of \< 30 days is not considered prior neoadjuvant therapy * No evidence of recurrent or metastatic disease * No history of breast cancer, except ductal carcinoma in situ or lobular carcinoma in situ * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Premenopausal or postmenopausal Performance status * Karnofsky 80-100% OR * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Creatinine ≤ 1.5 times upper limit of normal Other * Not pregnant or nursing * Fertile patients must use effective contraception * No active dental problems, including dental abscess or infection of the jaw bone (e.g., maxilla or mandible) * No prior or current diagnosis of osteonecrosis of the jaw * No other malignancy within the past 5 years (including prior contralateral breast cancer) except nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix * No history of disease with influence on bone metabolism, including any of the following: * Paget's disease of the bone * Primary hyperparathyroidism * Osteoporosis requiring treatment or likely to require treatment within the next 6 months * No other severe physical or psychological disease that would preclude study compliance * No known hypersensitivity to bisphosphonates PRIOR CONCURRENT THERAPY: Chemotherapy * See Disease Characteristics Endocrine therapy * See Disease Characteristics Radiotherapy * See Disease Characteristics Surgery * See Disease Characteristics * More than 4 weeks since prior and no concurrent dental or jaw surgery (e.g., extractions or implants) * Dental fillings, teeth scaling and polishing, or minor gingival surgery within the past 4 weeks are allowed Other * More than 1 year since prior bisphosphonates * More than 30 days since prior investigational drugs * No concurrent investigational drugs (i.e., not locally approved for any indication)