S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.

Not Recruiting

Trial ID: NCT00127205


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.

Official Title

Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer

Stanford Investigator(s)

Frank E. Stockdale
Frank E. Stockdale

Maureen Lyles D'Ambrogio Professor in the School of Medicine, Emeritus



   - 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



   - 18 and over


   - Female

Menopausal status

   - Not specified

Performance status

   - Zubrod 0-2

Life expectancy

   - Not specified


   - Not specified


   - Not specified


   - Creatinine ≤ 2 times upper limit of normal

   - Creatinine clearance ≥ 30 mL/min

   - No renal failure


   - 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


Biologic therapy

   - Prior or concurrent hematopoietic growth factors allowed

   - HER-2-targeted therapies allowed

   - Antiangiogenics allowed


   - See Disease Characteristics

Endocrine therapy

   - See Disease Characteristics


   - Concurrent radiotherapy to the breast, chest wall, or lymph node group allowed at the
   discretion of the treating physician


   - See Disease Characteristics


   - Prior neoadjuvant therapy allowed

   - Prior bisphosphonates for bone density allowed

   - No other concurrent bisphosphonates as adjuvant therapy or for treatment of

   - 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


drug: clodronate disodium

drug: ibandronate sodium

drug: zoledronic acid

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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