AzTrials
AzTrials

Breast CancerPhase 3NCT00320710

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

A Phase 3 study testing Zoledronic acid in people with Breast Cancer, run by Novartis Pharmaceuticals at 92 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Zoledronic acid
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
416 participants
Where
92 sitesUnited States
Study dates
Feb 2006to Jul 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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.

Trial locations and contacts

92 sites in 1 country.

92 sites in 1 country

United States92 sites

  • Cabrini Center for Cancer Care

    Alexandria, Louisiana, 71301

  • Pacific Cancer Medical Center, Inc.

    Anaheim, California, 92801

  • Providence Alaska Medical Center Cancer Research

    Anchorage, Alaska, 99508

  • University of Michigan Clinical Trials Office

    Ann Arbor, Michigan, 48109

  • Advanced Oncology Associates

    Armonk, New York, 10504

  • Greenbaum Cancer Center

    Baltimore, Maryland, 21201-1595

  • St. Agnes Hospital

    Baltimore, Maryland, 21229

  • The Harry and Jeanette Weinberg Cancer Institute at Franklin

    Baltimore, Maryland, 21237

  • Barberton Citizens Hospital

    Barberton, Ohio, 44203

  • Center for Cancer & Blood Disorders

    Bethesda, Maryland, 20817

  • Alamance Regional Medical Cancer Center

    Burlington, North Carolina, 27215

  • South Bay Oncology Hematology Partners

    Campbell, California, 95008

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Center for Cancer and Hematologic Disease

    Cherry Hill, New Jersey, 08003

  • NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr

    Chicago, Illinois, 60611

  • M. Francisco Gonzalez, MD., FACP

    Columbia, South Carolina, 29203

  • Bay Area Cancer Research

    Concord, California, 94520

  • Northeast Oncology Associates Suite 250

    Concord, North Carolina, 28025

  • Bay Area Hospital - Pharmacy

    Coos Bay, Oregon, 97420

  • The Corvallis Clinic, P.C.

    Corvallis, Oregon, 97330

  • Denver Health Medical Center CACZ885M2301

    Denver, Colorado, 80204-4507

  • Wayne State University

    Detroit, Michigan, 48201

  • Henry Ford Hospital Oncology

    Detroit, Michigan, 48202

  • Medical Associates Clinic, PC

    Dubuque, Iowa, 52001

  • St. Luke's Hospital and Health Network

    Duluth, Minnesota, 55805

  • Evanston Northwestern Healthcare Medical Group

    Evanston, Illinois, 60201

  • Providence Everett Medical Clinic

    Everett, Washington, 98201

  • Pacific Coast Hem/Onc

    Fountain Valley, California, 92708

  • Frederick Memorial Hospital

    Frederick, Maryland, 21701

  • Arena Oncology Associates, PC

    Great Neck, New York, 11021

  • Kentucky Lung Clinic & Kentucky Sleep Clinic

    Hazard, Kentucky, 41701

  • Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Heritage Physicians Group Oncology

    Hot Springs, Arkansas, 71913

  • MD Anderson Cancer Center/University of Texas 1155 Herman Pressler Street

    Houston, Texas, 77031

  • Investigative Clinical Research

    Indianapolis, Indiana, 46254

  • University of Iowa Health Care

    Iowa City, Iowa, 52242-1091

  • Jackson Oncology Associates

    Jackson, Mississippi, 39202

  • Baptist Cancer Center

    Jacksonville, Florida, 32209

  • Capitol Comprehensive Cancer Care Clinic

    Jefferson City, Missouri, 65109

  • Benedictine Hospital

    Kingston, New York, 12401

  • Wilshire Oncology Medical Group

    La Verne, California, 91750

  • Southwest Oncology Associates Ltd.

    Lafayette, Louisiana, 70503

  • Lancaster Cancer Center

    Lancaster, Pennsylvania, 17601

  • Nevada Cancer Centers 2851 North Tenaya Way

    Las Vegas, Nevada, 89109

  • Suburban Hematology-Oncology

    Lawrenceville, Georgia, 30045

  • Lexington Oncology Associates

    Lexington, Kentucky, 40503

  • Nebraska Hematology-Oncology PC

    Lincoln, Nebraska, 68506

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Kenmar Research Institute

    Los Angeles, California, 90057

  • Ohio Cancer Specialists

    Mansfield, Ohio, 44907

  • Caritas Holy Family Hospital

    Methuen, Massachusetts, 01844

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Fairview Clinical Trial Services

    Minneapolis, Minnesota, 55414

  • Univ. of Minnesota Cancer Center 420 Delaware St.

    Minneapolis, Minnesota, 55455

  • Edward Cancer Center

    Naperville, Illinois, 60540

  • Cancer Care Center

    New Albany, Indiana, 47150

  • Pasco Hernando Oncology

    New Port Richey, Florida, 34652

  • Beth Israel Medical Center

    New York, New York, 10003

  • Columbia Presbyterian Medical Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • North Valley Hematology/Oncology Providence Holy Cross Medical

    Northridge, California, 91328

  • Eastern Connecticut Hematology & Oncology Associates

    Norwich, Connecticut, 06360

  • Medical Oncology Care Associates

    Orange, California, 92868

  • Ventura County Hematology and Oncology

    Oxnard, California, 93030

  • U of Pittsburgh Cancer Institute Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • The Office of Dr. Elizabeth Tan-Chiu, MD PA

    Planatation, Florida, 33324

  • The Office of Dr. Swarna Chanduri, MD

    Pomona, California, 91767

  • Access Clinical Research

    Rancho Mirage, California, 92270

  • Cancer and Blood of the Desert

    Rancho Mirage, California, 92270

  • Hubert H. Humphrey Cancer Center

    Robbinsdale, Minnesota, 55422

  • Jmaes P. Wilmot Cancer Center

    Rochester, New York, 14642

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Oncology Care Associates, PLLC

    Saint Joseph, Michigan, 49085

  • Cancer Centers of South Texas

    San Antonio, Texas, 78229

  • Guthrie Cancer Center

    Sayre, Pennsylvania, 18840

  • Seattle Cancer Care Alliance Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Siouxland Hematology-Oncology Associates LLP

    Sioux City, Iowa, 51101

  • Midwest Cancer Research Group

    Skokie, Illinois, 60077

  • Somerset Hematology Oncology Associates

    Somerset, New Jersey, 08873

  • Rockwood Clinic Rockwood Clinic, PS

    Spokane, Washington, 99202

  • The Center for Chest Care

    Springdale, Arkansas, 72764

  • The Center for Cancer Care and Research

    St Louis, Missouri, 63141

  • Santee Hematology/Oncology

    Sumter, South Carolina, 29150

  • University of California at Los Angeles

    Sylmar, California, 91342

  • Associated Physicians & Surgeons Clinic

    Terre Haute, Indiana, 47804

  • Cotton O'Neil Oncology Clinic

    Topeka, Kansas, 66606

  • Georgetown University/Lombardi Cancer Center

    Washington D.C., District of Columbia, 20007-2197

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Hematology/Oncology Consultants Inc.

    West Worthington, Ohio, 43235

  • Cancer Center of Kansas

    Witchita, Kansas, 67214-3728

  • Trilogy Cancer Care

    Wooster, Ohio, 44691

  • Mainline Oncology Hematology Assoc.

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

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

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.

Conditions
Breast Cancer
Being tested
Zoledronic acid, Placebo
Keywords
Breast cancer, zoledronic acid, bone metastases
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zoledronic acidDrug

    Also called Zoledronate, ZOL446, Zometa

    4mg IV

  • PlaceboDrug

    Placebo to zoledronic acid

Study groups in NCT00320710
Study groupRoleWhat they receive
Zoledronic acid every (q) 4 weeksExperimentalParticipants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
Receives: Drug: Zoledronic acid
Zoledronic acid q 12 weeksExperimentalParticipants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
Receives: Drug: Zoledronic acid; Drug: Placebo
Placebo / zoledronic acidExperimentalParticipants randomized to this arm received placebo but the arm was later dropped and participants in this arm were swithced to the zoledronic acid q 4 weeks according to a study amendment.
Receives: Drug: Zoledronic acid; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients Who Experienced at Least One Skeletal Related Event (SRE)

    An SRE was defined as a pathologic fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone or surgery to bone.

    Measured: 52 weeks

Secondary outcomes (7)

  1. Time to First SRE

    An SRE was defined as a pathologic bone fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone, or surgery to bone. The time to first individual SRE was defined as the date of randomization to the date of first occurrence of any SRE.

    Measured: 52 weeks

  2. Time to First Individual Type of SRE

    Types of SREs analyzed were pathologic fractures (vertebral and non-vertebral), spinal cord compression, radiation to bone and surgery to bone. The time to first indvidual SRE was defined as the date of randomization to the date of the first occurrence of any individual SRE.

    Measured: 52 weeks

  3. Change From Baseline in Mean Composite Brief Pain Inventory (BPI) Score

    Participants completed a BPI short form which is a 9 item self-administered questionnaire used to evaluate the severity of a participant's pain and the impact of this pain on the participant's daily functioning. The participant rates his or her worst, least, average, and current pain intensity, lists current treatments and perceived effectiveness, and rates the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. The BPI composite score, which was calculated as the average of items 3, 4, 5 and 6 (worst pain, least pain, average pain and pain right now), ranged from 0 (best possible outcome, no pain) to 10 (worst possible outcome, pain as bad as you can imagine). A positive change from baseline indicates worsening.

    Measured: baseline, 52 weeks

  4. Change From Baseline in Mean Analgesic Score

    The analgesic score indicates the types of pain medication used. The scores range as follows: 0 = none medication; 1 = minor analgesics (aspirin, NSAID, acetaminophen, propoxyphene, etc.); 2 = Tranquilizers, antidepressants, muscle relaxants, and steroids; 3 = Mild narcotics (oxycodone, meperidine, codeine, etc.); and 4 = Strong narcotics (morphine, hydromorphone, etc.). A positive change from baseline indicates worsening.

    Measured: baseline, 52 weeks

  5. Change From Baseline in Urinary N-telopeptide / Creatinine Ratio

    Urine samples were collected to obtain n-telopeptide and creatinine values.

    Measured: baseline, 48 weeks

  6. Change From Baseline in Serum Bone Specific Alkaline Phosphatase

    Serum samples were collected to obtain bone specific alkaline phosphatase values.

    Measured: baseline, 48 weeks

  7. Skeletal Morbidity Rate

    An SMR for a patient was defined as the "number of occurrences" of any (or a particular) SRE allowing for only 1 event in any 3-week interval, divided by the "time at risk" in years. The "number of occurrences" and the "time at risk" were counts of SRE and the time from the randomization date. Counting began from randomization in the way that every counted event was followed by a 20-day period during which no SRE was counted, nor was the time counted as "at risk". For example, if a patient had 1 SRE during the study, the "time at risk" was calculated as the total number of days in the study minus the 20-day follow-up period for that SRE. If a patient had no SRE events, the entire study period was counted as "time at risk". This SMR calculation method had the advantage of avoiding multiple counts of possibly interdependent SREs (e.g. having 1 fracture increases the probability of having a subsequent SRE).

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionJul 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
416 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00320710
Sponsor's protocol ID
CZOL446E2352
Status last verified
Aug 2014
First submitted
28 Apr 2006
Last updated
22 Aug 2014
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28125763

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zoledronic acid in people with Breast Cancer, run by Novartis Pharmaceuticals at 92 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients Who Experienced at Least One Skeletal Related Event (SRE) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00320710, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in