Breast NeoplasmsPhase 1NCT00051779

An Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) in Patients With Breast Cancer

A Phase 1 study testing CAL in people with Breast Neoplasms and Breast Cancer, run by Chugai Pharma USA at 38 sites in United States.

Completed

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

Official record

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Trial summary

This study is intended to evaluate the safety, tolerability, and possible effectiveness of an investigational humanized monoclonal antibody (CAL) to the parathyroid hormone-related protein (PTHrP) when compared to zoledronic acid in patients with breast cancer metastatic to bone. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Neoplasms, Breast Cancer, Metastasis
What is being tested?: CAL
How many people: Not given
Where: 38 sitesUnited States
Study dates: Start not givento not given
Phase: Phase 1
Are there results?: None posted in the registry

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

Major Inclusion Criteria - Others Stipulated within the Protocol

The study physician must assure you have/are:

Must be a female at least 18 years of age and be using an effective form of birth control.
A documented history of breast cancer and at least one bone metastasis that has not been previously treated by radiation or surgery, and is not anticipated to be treated within the next 24 weeks.
A total body bone scan and other radiographic scan(s) performed on you within 4 weeks prior to or during the screening period sufficient to image all sites of bone metastases.
You must be willing to perform a daily telephone diary and be willing to keep a paper diary and provide voluntary consent to participate in this study.

Major Exclusion Criteria - Others Stipulated within the Protocol

The study physician must assure you do not have/are not:

A change in analgesic (pain relief) type medication during the screening period (example, non-narcotic to narcotic).
Received radiation therapy to any bone metastasis or started a new course of chemotherapy within 3 weeks prior to the screening visit or during the screening period.
Used any bisphosphonate type drug during the 30 days prior to the anticipated first dose of study drug
Vertebral spine or weight-bearing bone metastasis that would place you at imminent risk for fracture or surgical intervention.
Evidence of active infection or immune deficiency, renal failure, abnormal liver function, or a serum calcium level > 10.1 mg/dL.
Use of any investigational drug within 30 days prior to screening.

Trial locations and contacts

38 sites in 1 country.

City, postcode or hospital

38 sites in 1 country

United States38 sites

Anschutz Cancer Pavilion at the University of Colorado Cancer Center
Aurora, Colorado, 80010-0510
Dana-Farber/Harvard Cancer Center
Boston, Massachusetts, 02115
HemOnCare, P.C.
Brooklyn, New York, 11235
Rush Cancer Institute
Chicago, Illinois, 60612-3824
Ireland Cancer Center
Cleveland, Ohio, 44106
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Palmetto Health
Columbia, South Carolina, 29203
Hematology Oncology Consultants, Inc.
Columbus, Ohio, 43235
Bay Area Cancer Research Group
Concord, California, 94520
Cancer Specialists of South Texas, PA
Corpus Christi, Texas, 78412
Center for Oncology Research & Treatment
Dallas, Texas, 75230
Josephine Ford Cancer Center
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Frederick Memorial Hospital
Frederick, Maryland, 21701
Spectrum Health
Grand Rapids, Michigan, 49503
California Cancer Care, Inc.
Greenbrae, California, 94904
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Baylor College of Medicine
Houston, Texas, 77030
Nevada Cancer Center
Las Vegas, Nevada, 89109
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Kentucky Medical Center
Lexington, Kentucky, 40536-0098
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Institute of Cancer Therapies
Los Angeles, California
Boston Baskin Cancer Group
Memphis, Tennessee, 38104
The Boston Baskin Cancer Group
Memphis, Tennessee, 38104
The West Clinic
Memphis, Tennessee, 38120
Medical College of Wisconsin-FMLH East Neoplastic Diseases and Related Disorders
Milwaukee, Wisconsin, 53226
Yale University
New Haven, Connecticut, 06520-8028
Louisiana State University
New Orleans, Louisiana, 70112-2278
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
New Mexico Cancer Care Associates
Santa Fe, New Mexico, 87505
Southfield Oncology Institute, Inc.
Southfield, Michigan, 48076
Highlands Oncology Group
Springdale, Arkansas, 72764
St. Louis Center for Clinical Research
St Louis, Missouri, 63128
SUNY Upstate Medical University
Syracuse, New York, 12310
Montefiore Medical Center
The Bronx, New York, 10467-2490
San Diego Cancer Research Institute
Vista, California, 92083

Other trials in United States

About this study

Official title: A 24-Week Blinded Study Conducted at Multiple Centers, Evaluating the Safety and Effectiveness of Various Doses of the Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) When Randomly Assigned to Patients With Breast Cancer That Has Metastasized to Bone

The study will also evaluate the possible effects of both study drugs on performance status, markers of bone metabolism, and skeletal events related to bone metastasis including elevated blood calcium levels, bone pain, metastatic lesions, complications and interventions. The levels of CAL in the blood will also be evaluated.

Conditions: Breast Neoplasms, Breast Cancer, Metastasis
Being tested: CAL
Keywords: CAL, Parathyroid hormone-related protein (PTHrP), Breast Cancer, Bone Metastasis, Hypercalcemia
Medical subject headings: Breast Neoplasms, Neoplasm Metastasis, Hypercalcemia

What participants receive

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

CALDrug

Timeline

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

First posted17 Jan 2003 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1
Primary purpose: Treatment

IDs, dates and publications

ClinicalTrials.gov ID: NCT00051779
Sponsor's protocol ID: CAL-03
Status last verified: Feb 2004
First submitted: 16 Jan 2003
Last updated: 24 Jun 2005
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 24-Week Blinded Study Conducted at Multiple Centers, Evaluating the Safety and Effectiveness of Various Doses of the Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) When Randomly Assigned to Patients With Breast Cancer That Has Metastasized to Bone
ClinicalTrials.gov ID: NCT00051779
Acronym / sponsor ID: CAL-03
Conditions: Breast Neoplasms, Breast Cancer, Metastasis
Keywords: CAL, Parathyroid hormone-related protein (PTHrP), Breast Cancer, Bone Metastasis, Hypercalcemia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Lead sponsor: Chugai Pharma USAIndustry (pharma, biotech, devices)
First posted: 17 Jan 2003 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CAL	Drug	–

Primary outcome

Not reported in the source record.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.

Related trials for Breast Neoplasms

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

38 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CAL in people with Breast Neoplasms and Breast Cancer, run by Chugai Pharma USA at 38 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?

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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00051779.

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 24 Jun 2005.