Status:
COMPLETED
S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more effective than clo...
Detailed Description
OBJECTIVES: * Compare disease-free survival and overall survival of women with resected primary stage I-III adenocarcinoma of the breast treated with adjuvant zoledronate vs clodronate vs ibandronate...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2021
Estimated Enrollment :
6097 Patients enrolled
Trial Details
Trial ID
NCT00127205
Start Date
July 1 2005
End Date
March 29 2021
Last Update
July 2 2021
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