Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT00072020
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)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00072020
Study Brief:
Protocol Section:
NCT00072020