## Protocol Section
### Identification Module
**NCT ID:** NCT00051779

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

**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

#### Organization Study ID Info
**ID:** CAL-03
#### Organization
**Class:** INDUSTRY
**Full Name:** Chugai Pharma USA
### Status Module
#### Last Update Post Date
**Date:** 2005-06-24

**Type:** ESTIMATED

**Last Update Submit Date:** 2005-06-23

**Overall Status:** COMPLETED

**Status Verified Date:** 2004-02

#### Study First Post Date
**Date:** 2003-01-17
**Type:** ESTIMATED
**Study First Submit Date:** 2003-01-16
**Study First Submit QC Date:** 2003-01-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Chugai Pharma USA

### Description Module

**Brief 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.

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 Module

**Conditions:**

- Breast Neoplasms

- Breast Cancer

- Metastasis

**Keywords:**

- CAL

- Parathyroid hormone-related protein (PTHrP)

- Breast Cancer

- Bone Metastasis

- Hypercalcemia

### Design Module

#### Design Info

**Primary Purpose:** TREATMENT

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** CAL

**Type:** DRUG

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Little Rock

**Country:** United States

**Facility:** University of Arkansas for Medical Sciences

**State:** Arkansas

**Zip:** 72205

**Location 2:**

**City:** Springdale

**Country:** United States

**Facility:** Highlands Oncology Group

**State:** Arkansas

**Zip:** 72764

**Location 3:**

**City:** Concord

**Country:** United States

**Facility:** Bay Area Cancer Research Group

**State:** California

**Zip:** 94520

**Location 4:**

**City:** Greenbrae

**Country:** United States

**Facility:** California Cancer Care, Inc.

**State:** California

**Zip:** 94904

**Location 5:**

**City:** Los Angeles

**Country:** United States

**Facility:** Institute of Cancer Therapies

**State:** California

**Location 6:**

**City:** Vista

**Country:** United States

**Facility:** San Diego Cancer Research Institute

**State:** California

**Zip:** 92083

**Location 7:**

**City:** Aurora

**Country:** United States

**Facility:** Anschutz Cancer Pavilion at the University of Colorado Cancer Center

**State:** Colorado

**Zip:** 80010-0510

**Location 8:**

**City:** New Haven

**Country:** United States

**Facility:** Yale University

**State:** Connecticut

**Zip:** 06520-8028

**Location 9:**

**City:** Ft. Lauderdale

**Country:** United States

**Facility:** Holy Cross Hospital

**State:** Florida

**Zip:** 33308

**Location 10:**

**City:** Chicago

**Country:** United States

**Facility:** Rush Cancer Institute

**State:** Illinois

**Zip:** 60612-3824

**Location 11:**

**City:** Lexington

**Country:** United States

**Facility:** University of Kentucky Medical Center

**State:** Kentucky

**Zip:** 40536-0098

**Location 12:**

**City:** New Orleans

**Country:** United States

**Facility:** Louisiana State University

**State:** Louisiana

**Zip:** 70112-2278

**Location 13:**

**City:** Frederick

**Country:** United States

**Facility:** Frederick Memorial Hospital

**State:** Maryland

**Zip:** 21701

**Location 14:**

**City:** Boston

**Country:** United States

**Facility:** Dana-Farber/Harvard Cancer Center

**State:** Massachusetts

**Zip:** 02115

**Location 15:**

**City:** Detroit

**Country:** United States

**Facility:** Josephine Ford Cancer Center

**State:** Michigan

**Zip:** 48202

**Location 16:**

**City:** Grand Rapids

**Country:** United States

**Facility:** Spectrum Health

**State:** Michigan

**Zip:** 49503

**Location 17:**

**City:** Southfield

**Country:** United States

**Facility:** Southfield Oncology Institute, Inc.

**State:** Michigan

**Zip:** 48076

**Location 18:**

**City:** St. Louis

**Country:** United States

**Facility:** St. Louis Center for Clinical Research

**State:** Missouri

**Zip:** 63128

**Location 19:**

**City:** Las Vegas

**Country:** United States

**Facility:** Nevada Cancer Center

**State:** Nevada

**Zip:** 89109

**Location 20:**

**City:** Lebanon

**Country:** United States

**Facility:** Dartmouth Hitchcock Medical Center

**State:** New Hampshire

**Zip:** 03756

**Location 21:**

**City:** Santa Fe

**Country:** United States

**Facility:** New Mexico Cancer Care Associates

**State:** New Mexico

**Zip:** 87505

**Location 22:**

**City:** Bronx

**Country:** United States

**Facility:** Montefiore Medical Center

**State:** New York

**Zip:** 10467-2490

**Location 23:**

**City:** Brooklyn

**Country:** United States

**Facility:** HemOnCare, P.C.

**State:** New York

**Zip:** 11235

**Location 24:**

**City:** New York

**Country:** United States

**Facility:** Memorial Sloan Kettering Cancer Center

**State:** New York

**Zip:** 10021

**Location 25:**

**City:** Syracuse

**Country:** United States

**Facility:** SUNY Upstate Medical University

**State:** New York

**Zip:** 12310

**Location 26:**

**City:** Durham

**Country:** United States

**Facility:** Duke University Medical Center

**State:** North Carolina

**Zip:** 27710

**Location 27:**

**City:** Cleveland

**Country:** United States

**Facility:** Ireland Cancer Center

**State:** Ohio

**Zip:** 44106

**Location 28:**

**City:** Cleveland

**Country:** United States

**Facility:** University Hospitals of Cleveland

**State:** Ohio

**Zip:** 44106

**Location 29:**

**City:** Columbus

**Country:** United States

**Facility:** Hematology Oncology Consultants, Inc.

**State:** Ohio

**Zip:** 43235

**Location 30:**

**City:** Hershey

**Country:** United States

**Facility:** Penn State Hershey Medical Center

**State:** Pennsylvania

**Zip:** 17033

**Location 31:**

**City:** Columbia

**Country:** United States

**Facility:** Palmetto Health

**State:** South Carolina

**Zip:** 29203

**Location 32:**

**City:** Memphis

**Country:** United States

**Facility:** Boston Baskin Cancer Group

**State:** Tennessee

**Zip:** 38104

**Location 33:**

**City:** Memphis

**Country:** United States

**Facility:** The Boston Baskin Cancer Group

**State:** Tennessee

**Zip:** 38104

**Location 34:**

**City:** Memphis

**Country:** United States

**Facility:** The West Clinic

**State:** Tennessee

**Zip:** 38120

**Location 35:**

**City:** Corpus Christi

**Country:** United States

**Facility:** Cancer Specialists of South Texas, PA

**State:** Texas

**Zip:** 78412

**Location 36:**

**City:** Dallas

**Country:** United States

**Facility:** Center for Oncology Research & Treatment

**State:** Texas

**Zip:** 75230

**Location 37:**

**City:** Houston

**Country:** United States

**Facility:** Baylor College of Medicine

**State:** Texas

**Zip:** 77030

**Location 38:**

**City:** Milwaukee

**Country:** United States

**Facility:** Medical College of Wisconsin-FMLH East Neoplastic Diseases and Related Disorders

**State:** Wisconsin

**Zip:** 53226

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

- ID: D000009385

- Term: Neoplastic Processes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: HIGH

- As Found: Metastases

- ID: M9985

- Name: Hypercalcemia

- Relevance: LOW

- As Found: Unknown

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12330

- Name: Neoplastic Processes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

- ID: D000009362

- Term: Neoplasm Metastasis

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M1699

- Name: Zoledronic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M13194

- Name: Parathyroid Hormone

- Relevance: LOW

- As Found: Unknown

- ID: M25279

- Name: Parathyroid Hormone-Related Protein

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
