Clinical trial NCT00320710: Continued Efficacy and Safety of Zoledronic Acid (q 4 Wks vs. q 12 Wks) in the 2nd Year of Treatment in Patients With Bone Metastases From Breast Cancer
Official title: A Prospective, Randomized, Double-blind, Stratified, Multi-center, 2-arm Trial of the Continued Efficacy and Safety of Zoledronic Acid (Every 4 Weeks vs. Every 12 Weeks) in in the 2nd Year of Treatment in Patients With Documented Bone Metastases From Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast cancer
zoledronic acid
bone metastases
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-05-03
Enrollment: 416
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical trial in breast cancer patients with bone metastases pretreated for approximately 1 year with a standard zoledronic acid regimen. Looking at the continued effectiveness and safety of giving zoledronic acid every 4 weeks versus every 12 weeks given over 1 year. This study is prospective, double-blind, stratified, multi-center, and two-arm.


Eligibility criteria: Inclusion Criteria:

Female patients ≥ 18 years of age. Confirmed breast cancer with bone metastasis. Pretreated with Zometa®, or Aredia (pamidronate) or all sequential regimens of both, for a minimum of 9 doses;

Exclusion Criteria:

Abnormal kidney function determined by serum creatinine levels. Current active dental problems including: ongoing infection of the teeth or jawbone; current exposed bone in the mouth; and current or prior diagnosis of osteonecrosis of the jaw.

Recent (within 8 weeks) or planned dental or jaw surgery (e.g., extraction, implants).

Diagnosis of metabolic bone disease other than osteoporosis (e.g., Paget's disease of bone).

Known hypersensitivity to Zometa. Treatment with other investigational drugs within 30 days prior to randomization.

Other protocol-defined exclusion criteria may have applied.

Primary outcomes:
measure: Proportion of Patients Who Experienced at Least One Skeletal Related Event (SRE)
timeFrame: 52 weeks
Secondary outcomes:
measure: Time to First SRE
timeFrame: 52 weeks
measure: Time to First Individual Type of SRE
timeFrame: 52 weeks
measure: Change From Baseline in Mean Composite Brief Pain Inventory (BPI) Score
timeFrame: baseline, 52 weeks
measure: Change From Baseline in Mean Analgesic Score
timeFrame: baseline, 52 weeks
measure: Change From Baseline in Urinary N-telopeptide / Creatinine Ratio
timeFrame: baseline, 48 weeks
measure: Change From Baseline in Serum Bone Specific Alkaline Phosphatase
timeFrame: baseline, 48 weeks
measure: Skeletal Morbidity Rate
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Providence Alaska Medical Center Cancer Research
state: Alaska
city: Hot Springs
country: United States
facility: Heritage Physicians Group Oncology
state: Arkansas
city: Springdale
country: United States
facility: The Center for Chest Care
state: Arkansas
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center, Inc.
state: California
city: Campbell
country: United States
facility: South Bay Oncology Hematology Partners
state: California
city: Concord
country: United States
facility: Bay Area Cancer Research
state: California
city: Fountain Valley
country: United States
facility: Pacific Coast Hem/Onc
state: California
city: La Verne
country: United States
facility: Wilshire Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: Kenmar Research Institute
state: California
city: Northridge
country: United States
facility: North Valley Hematology/Oncology Providence Holy Cross Medical
state: California
city: Orange
country: United States
facility: Medical Oncology Care Associates
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology and Oncology
state: California
city: Pomona
country: United States
facility: The Office of Dr. Swarna Chanduri, MD
state: California
city: Rancho Mirage
country: United States
facility: Access Clinical Research
state: California
city: Rancho Mirage
country: United States
facility: Cancer and Blood of the Desert
state: California
city: Sacramento
country: United States
facility: University of California Davis Cancer Center
state: California
city: Sylmar
country: United States
facility: University of California at Los Angeles
state: California
city: Denver
country: United States
facility: Denver Health Medical Center CACZ885M2301
state: Colorado
city: Norwich
country: United States
facility: Eastern Connecticut Hematology & Oncology Associates
state: Connecticut
city: Washington
country: United States
facility: Georgetown University/Lombardi Cancer Center
state: District of Columbia
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Baptist Cancer Center
state: Florida
city: New Port Richey
country: United States
facility: Pasco Hernando Oncology
state: Florida
city: Planatation
country: United States
facility: The Office of Dr. Elizabeth Tan-Chiu, MD PA
state: Florida
city: Lawrenceville
country: United States
facility: Suburban Hematology-Oncology
state: Georgia
city: Chicago
country: United States
facility: NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr
state: Illinois
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare Medical Group
state: Illinois
city: Naperville
country: United States
facility: Edward Cancer Center
state: Illinois
city: Skokie
country: United States
facility: Midwest Cancer Research Group
state: Illinois
city: Indianapolis
country: United States
facility: Investigative Clinical Research
state: Indiana
city: New Albany
country: United States
facility: Cancer Care Center
state: Indiana
city: Terre Haute
country: United States
facility: Associated Physicians & Surgeons Clinic
state: Indiana
city: Dubuque
country: United States
facility: Medical Associates Clinic, PC
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Health Care
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology Associates LLP
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Oncology Clinic
state: Kansas
city: Witchita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Hazard
country: United States
facility: Kentucky Lung Clinic & Kentucky Sleep Clinic
state: Kentucky
city: Lexington
country: United States
facility: Lexington Oncology Associates
state: Kentucky
city: Alexandria
country: United States
facility: Cabrini Center for Cancer Care
state: Louisiana
city: Lafayette
country: United States
facility: Southwest Oncology Associates Ltd.
state: Louisiana
city: Baltimore
country: United States
facility: Greenbaum Cancer Center
state: Maryland
city: Baltimore
country: United States
facility: St. Agnes Hospital
state: Maryland
city: Baltimore
country: United States
facility: The Harry and Jeanette Weinberg Cancer Institute at Franklin
state: Maryland
city: Bethesda
country: United States
facility: Center for Cancer & Blood Disorders
state: Maryland
city: Frederick
country: United States
facility: Frederick Memorial Hospital
state: Maryland
city: Methuen
country: United States
facility: Caritas Holy Family Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Clinical Trials Office
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital Oncology
state: Michigan
city: St. Joseph
country: United States
facility: Oncology Care Associates, PLLC
state: Michigan
city: Duluth
country: United States
facility: St. Luke's Hospital and Health Network
state: Minnesota
city: Minneapolis
country: United States
facility: Fairview Clinical Trial Services
state: Minnesota
city: Minneapolis
country: United States
facility: Univ. of Minnesota Cancer Center 420 Delaware St.
state: Minnesota
city: Robbinsdale
country: United States
facility: Hubert H. Humphrey Cancer Center
state: Minnesota
city: Jackson
country: United States
facility: Jackson Oncology Associates
state: Mississippi
city: Jefferson City
country: United States
facility: Capitol Comprehensive Cancer Care Clinic
state: Missouri
city: St. Louis
country: United States
facility: The Center for Cancer Care and Research
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Hematology-Oncology PC
state: Nebraska
city: Las Vegas
country: United States
facility: Nevada Cancer Centers 2851 North Tenaya Way
state: Nevada
city: Cherry Hill
country: United States
facility: Center for Cancer and Hematologic Disease
state: New Jersey
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
city: Somerset
country: United States
facility: Somerset Hematology Oncology Associates
state: New Jersey
city: Armonk
country: United States
facility: Advanced Oncology Associates
state: New York
city: Great Neck
country: United States
facility: Arena Oncology Associates, PC
state: New York
city: Kingston
country: United States
facility: Benedictine Hospital
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rochester
country: United States
facility: Jmaes P. Wilmot Cancer Center
state: New York
city: Burlington
country: United States
facility: Alamance Regional Medical Cancer Center
state: North Carolina
city: Concord
country: United States
facility: Northeast Oncology Associates Suite 250
state: North Carolina
city: Barberton
country: United States
facility: Barberton Citizens Hospital
state: Ohio
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Mansfield
country: United States
facility: Ohio Cancer Specialists
state: Ohio
city: West Worthington
country: United States
facility: Hematology/Oncology Consultants Inc.
state: Ohio
city: Wooster
country: United States
facility: Trilogy Cancer Care
state: Ohio
city: Coos Bay
country: United States
facility: Bay Area Hospital - Pharmacy
state: Oregon
city: Corvallis
country: United States
facility: The Corvallis Clinic, P.C.
state: Oregon
city: Hershey
country: United States
facility: Milton S Hershey Medical Center
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: U of Pittsburgh Cancer Institute Magee-Womens Hospital
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Cancer Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: Mainline Oncology Hematology Assoc.
state: Pennsylvania
city: Columbia
country: United States
facility: M. Francisco Gonzalez, MD., FACP
state: South Carolina
city: Sumter
country: United States
facility: Santee Hematology/Oncology
state: South Carolina
city: Houston
country: United States
facility: MD Anderson Cancer Center/University of Texas 1155 Herman Pressler Street
state: Texas
city: San Antonio
country: United States
facility: Cancer Centers of South Texas
state: Texas
city: Everett
country: United States
facility: Providence Everett Medical Clinic
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance Seattle Cancer Care Alliance
state: Washington
city: Spokane
country: United States
facility: Rockwood Clinic Rockwood Clinic, PS
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Hortobagyi GN, Van Poznak C, Harker WG, Gradishar WJ, Chew H, Dakhil SR, Haley BB, Sauter N, Mohanlal R, Zheng M, Lipton A. Continued Treatment Effect of Zoledronic Acid Dosing Every 12 vs 4 Weeks in Women With Breast Cancer Metastatic to Bone: The OPTIMIZE-2 Randomized Clinical Trial. JAMA Oncol. 2017 Jul 1;3(7):906-912. doi: 10.1001/jamaoncol.2016.6316.