Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases

NCT00060138 | Completed Phase 1

• 4 other identifiers: CWRU-080235CDR0000299530CBI-1102CBI-CAL-03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Hypercalcemia of Malignancy; Metastatic Cancer; Pain

Keywords

hypercalcemia of malignancy; stage IV breast cancer; recurrent breast cancer; bone metastases; pain

Interventions

monoclonal antibody CAL BIOLOGICAL

zoledronic acid DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Chugai Pharmaceutical: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Humoral Hypercalcemia Of Malignancy; Neoplasm Metastasis; Pain

Interventions

Antibodies, Monoclonal; Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Paula Silverman, MD

  Case Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 6, 2003
• First Posted: May 7, 2003
• Study Start: November 1, 2002
• Primary Completion: September 1, 2004
• Last Updated: May 15, 2013

Record last verified: 2013-05

Locations

US (1)