Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer

Inclusion 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)