S0308 Zoledronate or Ibandronate in Preventing Bone Problems in Women With Stage IV Breast Cancer That Has Spread to the Bone

NCT00301886 | Withdrawn Phase 3 DMC

• 3 other identifiers: CDR0000463758S0308U10CA037429
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Zoledronate and ibandronate may prevent or help relieve bone pain and other symptoms caused by bone metastases. It is not yet known whether zoledronate is more effective than ibandronate in preventing bone problems caused by bone metastases due to breast cancer. PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to ibandronate in preventing bone problems in women with stage IV breast cancer that has spread to the bone.

Conditions

Breast Cancer; Hypercalcemia of Malignancy; Metastatic Cancer; Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Skeletal-related events (SRE)

Secondary Outcomes (4)

• Change in patient's rating of worst pain as measured by the Brief Pain Inventory

• Survival and time to first clinically apparent SRE

• Tolerability and toxicity as measured by NCI CTCAE v3.0

• Changes in performance status

Study Arms (2)

zoledronate

EXPERIMENTAL

zoledronate

Drug: zoledronate; Procedure: quality-of-life assessment

ibandronate

EXPERIMENTAL

ibandronate

Drug: ibandronate; Procedure: quality-of-life assessment

Interventions

ibandronate DRUG

Also known as: ibandronate sodium

ibandronate

zoledronate DRUG

Also known as: zoledronic acid

zoledronate

quality-of-life assessment PROCEDURE

ibandronate; zoledronate

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed stage IV breast cancer at primary diagnosis or at recurrence * Any T, any N, M1 * At least 1 dominant osteolytic or osteoblastic or mixed metastatic lesion outside any prior radiation field * Lesion measures ≥ 1.0 cm by x-ray, CT scan, and/or MRI * Controlled asymptomatic brain metastases allowed * Controlled bone pain, defined as a physician/health care provider rating of ≤ grade 2 pain-SELECT (Bone) on the NCI CTC for Adverse Events Version 3.0 rating scale, required * Current evidence of vertebral or nonvertebral fractures or spinal compression due to cancer, as determined by the treating physician, allowed * No Paget's disease of the bone * Estrogen receptor (ER) or progesterone receptor (PR) status known PATIENT CHARACTERISTICS: * Female patient * Menopausal status not specified * Zubrod performance status 0-2 * Creatinine normal * Creatinine clearance ≥ 60 mL/min * Serum calcium \< 12 mg/dL * Not pregnant or nursing * Fertile patients must use effective contraception * Must be able to receive IV medication and oral medication (i.e., must have physical integrity of the upper gastrointestinal tract) * No malabsorption syndrome * No primary hyperparathyroidism * No known history of aspirin-sensitive asthma * No other prior malignancy except for the following: * Adequately treated basal cell or squamous cell skin cancer * In situ cervical cancer * Adequately treated stage I or II cancer currently in complete remission * Any other cancer for which the patient has been disease-free for at least 5 years * No uncontrolled medical illness or infection, including, but not limited to, the following: * Unstable angina * Recent myocardial infarction * Life-threatening cardiac arrhythmia PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior bisphosphonates for metastatic bone disease * More than 28 days since prior aminoglycoside antibiotics * At least 28 days since prior oral bisphosphonates for osteoporosis * More than 6 months since prior bisphosphonates used for adjuvant therapy * Concurrent treatment, including chemotherapy, hormonal therapy, and/or biologic therapy for metastatic breast cancer allowed * No concurrent participation in another clinical treatment trial for this cancer unless the patient is no longer receiving the intervention and is in the follow-up phase of the other clinical trial

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

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

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

Interventions

Ibandronic Acid; 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)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Saul E. Rivkin, MD

  Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

  STUDY CHAIR

• Kathy S. Albain, MD

  Loyola University

  STUDY CHAIR

• Dawn Hershman, MD

  Herbert Irving Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2006
• First Posted: March 13, 2006
• Study Start: May 1, 2006
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: November 13, 2013

Record last verified: 2013-11