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

Breast Cancer Clinical Trial

Official title:

A Phase II Study of Goserelin Plus Anastrozole for the Treatment of Male Patients With Hormone-Receptor Positive Metastatic or Recurrent Breast Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00217659
• Other study ID #: CDR0000442919
• Secondary ID: S0511U10CA032102
• Status: Withdrawn
• Phase: Phase 2
• First received: September 20, 2005
• Last updated: January 2, 2013
• Start date: September 2005
• Est. completion date: January 2007

Study information

• Verified date: January 2013
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• Determine the progression-free survival (PFS) of men with estrogen receptor- or progesterone receptor-positive recurrent or metastatic breast cancer treated with goserelin and anastrozole.

• Determine the overall survival of patients treated with this regimen.

• Determine the overall objective tumor response rate (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with this regimen.

• Correlate prostate specific antigen (PSA), testosterone, estradiol, estrone, estrone sulfate, follicle-stimulating hormone, luteinizing hormone, and dehydroepiandrosterone levels with PFS and response in patients treated with this regimen.

• Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive goserelin subcutaneously on day 1 and oral anastrozole on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at approximately 4-6 weeks and then every 3-6 months for up to 3 years.

PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study within 48 months.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• anastrozole

• goserelin acetate

Locations

Country	Name	City	State
United States	AnMed Health Cancer Center	Anderson	South Carolina
United States	University of Colorado Cancer Center at UC Health Sciences Center	Aurora	Colorado
United States	Billings Clinic Cancer Center	Billings	Montana
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Deaconess Billings Clinic - Downtown	Billings	Montana
United States	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana
United States	Northern Rockies Radiation Oncology Center	Billings	Montana
United States	St. Vincent Healthcare	Billings	Montana
United States	Bozeman Deaconess Hospital	Bozeman	Montana
United States	St. James Community Hospital	Butte	Montana
United States	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	Veterans Affairs Medical Center - Denver	Denver	Colorado
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas
United States	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas
United States	Broward General Medical Center Cancer Center	Ft. Lauderdale	Florida
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Great Falls Clinic	Great Falls	Montana
United States	St. Peter's Hospital	Helena	Montana
United States	Community Oncology Group at Cleveland Clinic Cancer Center	Independence	Ohio
United States	Glacier Oncology, PLLC	Kalispell	Montana
United States	Kalispell Medical Oncology	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas
United States	Southwest Medical Center	Liberal	Kansas
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Community Medical Center	Missoula	Montana
United States	Guardian Oncology and Center for Wellness	Missoula	Montana
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana
United States	Montrose Memorial Hospital Cancer Center	Montrose	Colorado
United States	Cancer Center of Kansas, PA - Newton	Newton	Kansas
United States	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas
United States	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	University of California Davis Cancer Center	Sacramento	California
United States	Cancer Center of Kansas, PA - Salina	Salina	Kansas
United States	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas
United States	Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia
United States	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas
United States	Exempla Lutheran Medical Center	Wheat Ridge	Colorado
United States	Associates in Womens Health, PA - North Review	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas
United States	Cleveland Clinic - Wooster	Wooster	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)			No
Primary	Overall survival			No
Primary	Overall objective tumor response rate (confirmed and unconfirmed, complete and partial)			No
Primary	Correlation of prostate specific antigen, testosterone, estradiol, estrone, estrone sulfate, follicle-stimulating hormone, luteinizing hormone, and dehydroepiandrosterone levels with PFS			No
Primary	Toxicity			Yes