S0511, Goserelin and Anastrozole in Treating Men With Recurrent or Metastatic Breast Cancer

NCT00217659 | Withdrawn Phase 2 DMC

• 3 other identifiers: CDR0000442919S0511U10CA032102
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 57

Brief Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using goserelin and anastrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving goserelin together with anastrozole may be an effective treatment for male breast cancer. PURPOSE: This phase II trial is studying how well giving goserelin together with anastrozole works in treating men with recurrent or metastatic breast cancer.

Conditions

Breast Cancer

Keywords

male breast cancer; recurrent breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (5)

• Progression-free survival (PFS)

• Overall survival

• Overall objective tumor response rate (confirmed and unconfirmed, complete and partial)

• Correlation of prostate specific antigen, testosterone, estradiol, estrone, estrone sulfate, follicle-stimulating hormone, luteinizing hormone, and dehydroepiandrosterone levels with PFS

• Toxicity

Interventions

anastrozole DRUG

goserelin acetate DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed breast cancer * Recurrent or metastatic (stage IV) disease * Patients with a local regional recurrence, including axillary and/or chest wall involvement, are eligible * Measurable or non-measurable disease * Brain metastases allowed provided they have been treated with surgery or radiotherapy AND have remained stable for ≥ 3 months * Hormone receptor status: * Estrogen receptor- OR progesterone receptor- positive disease by standard immunohistochemical techniques PATIENT CHARACTERISTICS: Age * 18 and over Sex * Male Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * No evidence of severe or uncontrolled hepatic disease Renal * No evidence of severe or uncontrolled renal disease Cardiovascular * No evidence of severe or uncontrolled cardiac disease Pulmonary * No evidence of severe or uncontrolled respiratory disease Other * Fertile patients must use effective barrier-method contraception during and for 12 weeks after the completion of study treatment * No known HIV positivity * Able to receive oral medication * Patients with a gastrointestinal tube are eligible * No known hypersensitivity to luteinizing hormone-releasing hormone (LHRH), LHRH agonist analogues, or any components of the study drugs * No active infection requiring systemic therapy * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer * No evidence of other severe or uncontrolled systemic disease PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent prophylactic filgrastim (G-CSF) or other hematopoietic growth factors Chemotherapy * At least 14 days since prior chemotherapy for this cancer and recovered * No more than 1 prior chemotherapy regimen for metastatic disease * No concurrent chemotherapy Endocrine therapy * At least 14 days since prior hormonal therapy for this cancer and recovered * Prior tamoxifen allowed * No prior gonadotropin-releasing hormone antagonist, aromatase inhibitors, or fulvestrant * No other concurrent hormonal therapy (e.g., estrogen-based therapies) Radiotherapy * See Disease Characteristics * At least 14 days since prior radiotherapy for this cancer and recovered * No concurrent radiotherapy Surgery * See Disease Characteristics

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

Study Sites (57)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, United States

Location

Montrose Memorial Hospital Cancer Center

Montrose, Colorado, 81401, United States

Location

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, 80033, United States

Location

Broward General Medical Center Cancer Center

Fort Lauderdale, Florida, 33316, United States

Location

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31403-3089, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, 62781-0001, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67042, United States

Location

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65802, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare

Billings, Montana, 59101, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59107-5100, United States

Location

Deaconess Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

St. James Community Hospital

Butte, Montana, 59701, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

Unknown Facility

Great Falls, Montana, 59405, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology, PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology

Kalispell, Montana, 59901, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Community Medical Center

Missoula, Montana, 59801, United States

Location

Guardian Oncology and Center for Wellness

Missoula, Montana, 59804, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59807, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Community Oncology Group at Cleveland Clinic Cancer Center

Independence, Ohio, 44131, United States

Location

Cleveland Clinic - Wooster

Wooster, Ohio, 44691, United States

Location

AnMed Health Cancer Center

Anderson, South Carolina, 29621, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, 82801, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Anastrozole; Goserelin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Zeina Nahleh, MD

  Barrett Cancer Center

• Abdul-Rahman Jazieh, MD, MPH

  Barrett Cancer Center

• Robert B. Livingston, MD

  University of Washington

• Gabriel N. Hortobagyi, MD, FACP

  M.D. Anderson Cancer Center

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: September 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: January 3, 2013

Record last verified: 2013-01

Locations

US (57)