At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed invasive adenocarcinoma, T1-3, N0-1, M0 (non-metastatic)
- ✓Total mastectomy or lumpectomy with axillary dissection or sentinel node biopsy; if sentinel node positive, completion axillary dissection required
- ✓Estrogen and/or progesterone receptor analysis on primary tumor completed prior to randomization
- ✓Zubrod performance status 0, 1, or 2
- ✕Prior therapy for breast cancer including irradiation, chemotherapy, biotherapy, or hormonal therapy, except tamoxifen started ≤28 days before randomization
- ✕Prior history of breast cancer except LCIS
- ✕Current use of alendronate, other bisphosphonates, or calcitonin for osteoporosis treatment/prevention
- ✕Significant non-malignant bone disease likely to interfere with bone X-ray interpretation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Clinical Trial Comparing Adjuvant Clodronate Therapy vs Placebo in Early-Stage Breast Cancer Patients Receiving Systemic Chemotherapy and/or Hormonal Therapy or No Therapy
In Brief
A Phase 3 clinical trial evaluating clodronate and placebo for Breast Cancer. Completed, enrolled 3,323 participants across 17 sites.
Detailed Summary
RATIONALE: Clodronate may be effective in preventing the spread of cancer to the bones and other parts of the body. It is not yet known whether clodronate is more effective alone or combined with chemotherapy and /or hormonal therapy in preventing metastatic breast cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of clodronate with or without chemotherapy and /or hormonal therapy in preventing metastases in women who have stage I or stage II breast cancer.
Study Details
Timeline
Interventions
1600 mg PO daily
2 pills PO daily