| Phase III Randomized Study of Adjuvant Zoledronate Versus Clodronate Versus Ibandronate in Women With Resected Primary Stage I-III Adenocarcinoma of the Breast
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information
Alternate Title
Zoledronate, Clodronate, or Ibandronate in Treating Women Who Have Undergone Surgery for Stage I, Stage II, or Stage III Breast Cancer
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Treatment | Closed | 18 and over | SWOG-S0307
NCCTG-SWOG-S0307, ECOG-SWOG-S0307, NSABP-SWOG-S0307, CALGB-SWOG-S0307, CAN-NCIC-SWOG-S0307, S0307, NCT00127205 |
Special Category:
CTSU trial, NCI Web site featured trial 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.
- Compare the distributions of sites of first disease recurrence in patients treated with these drugs.
- Compare adverse events in patients treated with these drugs.
- Correlate parathyroid hormone related protein status and N-telopeptide levels at baseline with disease-free survival and sites of first recurrence in patients treated with these drugs.
- Investigate whether there is an association between inherited germ-line single
nucleotide polymorphisms (SNP, rs2297480) in farnesyl diphosphate sythase (FDPS)
and the adverse event of acute phase reactions in these patients.
Entry 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:
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
Patient Characteristics:
Age Sex Menopausal status Performance status Life expectancy Hematopoietic Hepatic 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
Expected Enrollment 5400A total of 5,400 will be accrued for this study. Outcomes Primary Outcome(s)Histologic confirmation of disease recurrence
Sites of first disease recurrence
Disease-free survival
Overall survival
Zubrod performance status
Secondary Outcome(s)Correlation of inherited germ-line single
nucleotide polymorphisms (SNP, rs2297480) in farnesyl diphosphate sythase (FDPS)
with adverse event of acute phase reactions
Outline This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms. - Arm I: Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.
- Arm II: Patients receive oral clodronate once daily for 3 years.
- Arm III: Patients receive oral ibandronate once daily for 3 years.
Treatment in all arms continues in the absence of disease recurrence or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months until disease recurrence and then annually for up to 10 years.
Trial Contact Information
Trial Lead Organizations Southwest Oncology Group  | | | | Julie Gralow, MD, Study coordinator | | | | | Robert Livingston, MD, Study coordinator | | | |
North Central Cancer Treatment Group | | | | James Ingle, MD, Study coordinator | | | |
Eastern Cooperative Oncology Group | | | | Carla Falkson, MD, Study coordinator | | | |
National Surgical Adjuvant Breast and Bowel Project | | | | Alexander Paterson, MD, FRCP, FACP, MBChB, Study coordinator | | | |
Cancer and Leukemia Group B | | | | Elizabeth Dees, MD, Study coordinator | | | |
NCIC-Clinical Trials Group | | | | Mark Clemons, MD, Study coordinator | | | |
Related Information Featured trial article
| Registry Information | | | Official Title | | Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer | | | Trial Start Date | | 2005-07-15 | | | Trial Completion Date | | 2009-12-15 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00127205 | | | Date Submitted to PDQ | | 2005-06-09 | | | Information Last Verified | | 2010-01-16 | | | NCI Grant/Contract Number | | CA32102 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
