Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer
Breast Cancer, Metastatic Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring bone metastases, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
Eligibility Criteria
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)