Clinical trial · Interventional
S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.
Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
NCT00127205CI-TRIAL-00052535completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 clodronate or ibandronate in treating breast cancer. PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to clodronate or ibandronate in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clodronate disodium | Drug | — | UNRESOLVED |
| ibandronate sodium | Drug | Ibandronic Acid | ALIAS |
| zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.
- interventionNames
- Drug: zoledronic acid
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Patients receive oral clodronate once daily for 35 months.
- interventionNames
- Drug: clodronate disodium
- type
- EXPERIMENTAL
- label
- Arm III
- description
- Patients receive oral ibandronate once daily for 35 months.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDAdams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2. PMID 38979716
- DERIVEDKizub DA, Miao J, Schubert MM, Paterson AHG, Clemons M, Dees EC, Ingle JN, Falkson CI, Barlow WE, Hortobagyi GN, Gralow JR. Risk factors for bisphosphonate-associated osteonecrosis of the jaw in the prospective randomized trial of adjuvant bisphosphonates for early-stage breast cancer (SWOG 0307). Support Care Cancer. 2021 May;29(5):2509-2517. doi: 10.1007/s00520-020-05748-8. Epub 2020 Sep 15. PMID 32929540