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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT00127205
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed primary adenocarcinoma of the breast
* Stage I-III disease
* No evidence of metastatic disease
* Must have undergone lumpectomy or total mastectomy for primary disease within the past 12 weeks, or have completed chemotherapy within the past 8 weeks
* Axillary evaluation per institutional standards
* Currently receiving or planning to receive standard adjuvant systemic therapy comprising chemotherapy, hormonal therapy, or combined chemotherapy/hormonal therapy for breast cancer
* Patients who are at low risk for disease recurrence and for whom adjuvant systemic therapy will not be prescribed are not eligible
* Patients who receive biologic agents only or local radiotherapy only (without chemotherapy and/or hormone therapy) are not eligible
* Additional therapies are allowed including radiotherapy and biologic agents (e.g., trastuzumab \[Herceptin\^®\], bevacizumab, or hematopoietic growth factors)
* Neoadjuvant therapy or hormonal therapy alone is allowed provided study entry occurs ≥ 12 weeks after completion of surgery
* Patients with skeletal pain are eligible provided bone scan and/or roentgenological exam are negative for metastatic disease
* Suspicious findings must be confirmed as benign by x-ray, MRI, or biopsy
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Menopausal status
* Not specified
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Creatinine ≤ 2 times upper limit of normal
* Creatinine clearance ≥ 30 mL/min
* No renal failure
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of esophageal stricture or motility disorders
* Gastroesophageal reflux disorder allowed
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Prior or concurrent hematopoietic growth factors allowed
* HER-2-targeted therapies allowed
* Antiangiogenics allowed
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* See Disease Characteristics
Radiotherapy
* Concurrent radiotherapy to the breast, chest wall, or lymph node group allowed at the discretion of the treating physician
Surgery
* See Disease Characteristics
Other
* Prior neoadjuvant therapy allowed
* Prior bisphosphonates for bone density allowed
* No other concurrent bisphosphonates as adjuvant therapy or for treatment of osteoporosis
* No concurrent enrollment in clinical trials with bone density as an endpoint
* Concurrent enrollment on any other locoregional or systemic therapy breast cancer study (including cooperative group studies) allowed
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00127205
Study Brief:
Protocol Section:
NCT00127205