Breast Cancer Clinical Trial
Official title:
A Phase I-II, 24-Week, Multi-Center, Double-Blind, Randomized, Dose-Ranging Study To Evaluate The Safety And Efficacy Of A Humanized Monoclonal Antibody To PTHrP Versus Zoledronic Acid In Patients With Breast Cancer Metastatic To Bone
Verified date | May 2013 |
Source | Chugai Pharmaceutical |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
tumor-killing substances to them without harming normal cells. Zoledronate may prevent bone
loss and stop the growth of tumor cells in bone. It is not yet known whether monoclonal
antibody is more effective than zoledronate in treating women who have breast cancer and
bone metastases.
PURPOSE: Randomized phase I/II trial to compare the effectiveness of monoclonal antibody
with that of zoledronate in treating women who have breast cancer and bone metastases.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | September 2004 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed breast cancer - Radiographical evidence of at least 1 bone metastasis - No prior radiotherapy or surgery to bone metastasis - No radiotherapy or surgery anticipated for bone metastasis within the next 24 weeks - Bone pain severity score of at least 1 on 5 of 7 days as determined by question 3 of the Brief Pain Inventory (BPI) - No bone metastases to a weight-bearing bone at imminent risk for pathologic fracture or surgical intervention - No vertebral metastases that place the patient at imminent risk of spinal cord compression - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Pre- or post-menopausal Performance status - ECOG 0-2 Life expectancy - At least 6 months Hematopoietic - WBC at least 2,000/mm^3 - Lymphocyte count at least 500/mm^3 - Granulocyte count at least 1,000/mm^3 - Platelet count at least 50,000/mm^3 Hepatic - ALT or AST no greater than 2.5 times upper limit of normal (ULN) - Bilirubin no greater than 1.5 times ULN Renal - Calcium no greater than 10.1 mg/dL - No oliguria, defined as less than 30 mL urine per 2-hour collection - No acute renal failure - Creatinine no greater than 2.5 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception - No sepsis - No known or anticipated contraindication to study drugs PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 3 weeks since initiation of a new chemotherapy regimen Endocrine therapy - More than 3 weeks since initiation of a new hormonal therapy regimen Radiotherapy - See Disease Characteristics - More than 3 weeks since prior radiotherapy Surgery - See Disease Characteristics Other - More than 60 days since prior bisphosphonates - More than 30 days since prior investigational drugs - No change in analgesic drug regimen during the screening period |
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Ireland Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Chugai Pharmaceutical | National Cancer Institute (NCI) |
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