Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Southwest Oncology Group

Collaborator: NCIC Clinical Trials Group

Stanford Investigator(s):

Intervention(s):

  • Drug: clodronate disodium
  • Drug: ibandronate sodium
  • Drug: zoledronic acid

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting