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

• Status: Completed
• Trial end date: 2021-03-29
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborators: Cancer and Leukemia Group B; Eastern Cooperative Oncology Group; National Cancer Institute (NCI); NCIC Clinical Trials Group; North Central Cancer Treatment Group; NSABP Foundation Inc
• Treatments: Clodronic Acid; Diphosphonates; Ibandronic Acid; Zoledronic Acid

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:

• 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