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

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
anastrozole
goserelin acetate
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring male breast cancer, recurrent breast cancer, stage IV breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • USC/Norris Comprehensive Cancer Center and Hospital
  • University of California Davis Cancer Center
  • University of Colorado Cancer Center at UC Health Sciences Center
  • Veterans Affairs Medical Center - Denver
  • Montrose Memorial Hospital Cancer Center
  • Exempla Lutheran Medical Center
  • Broward General Medical Center Cancer Center
  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  • Decatur Memorial Hospital Cancer Care Institute
  • Regional Cancer Center at Memorial Medical Center
  • Cancer Center of Kansas, PA - Chanute
  • Cancer Center of Kansas, PA - Dodge City
  • Cancer Center of Kansas, PA - El Dorado
  • Cancer Center of Kansas, PA - Kingman
  • Southwest Medical Center
  • Cancer Center of Kansas, PA - Newton
  • Cancer Center of Kansas, PA - Parsons
  • Cancer Center of Kansas, PA - Pratt
  • Cancer Center of Kansas, PA - Salina
  • Tammy Walker Cancer Center at Salina Regional Health Center
  • Cancer Center of Kansas, PA - Wellington
  • Associates in Womens Health, PA - North Review
  • Cancer Center of Kansas, PA - Medical Arts Tower
  • Cancer Center of Kansas, PA - Wichita
  • CCOP - Wichita
  • Via Christi Cancer Center at Via Christi Regional Medical Center
  • Cancer Center of Kansas, PA - Winfield
  • Josephine Ford Cancer Center at Henry Ford Hospital
  • CCOP - Cancer Research for the Ozarks
  • St. John's Regional Health Center
  • CCOP - Montana Cancer Consortium
  • Hematology-Oncology Centers of the Northern Rockies - Billings
  • Northern Rockies Radiation Oncology Center
  • St. Vincent Healthcare
  • Billings Clinic Cancer Center
  • Deaconess Billings Clinic - Downtown
  • Bozeman Deaconess Hospital
  • St. James Community Hospital
  • Great Falls Clinic
  • St. Peter's Hospital
  • Glacier Oncology, PLLC
  • Kalispell Medical Oncology
  • Kalispell Regional Medical Center
  • Community Medical Center
  • Guardian Oncology and Center for Wellness
  • Montana Cancer Specialists at Montana Cancer Center
  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
  • Wayne Memorial Hospital, Incorporated
  • Rutherford Hospital
  • Cleveland Clinic Taussig Cancer Center
  • Community Oncology Group at Cleveland Clinic Cancer Center
  • Cleveland Clinic - Wooster
  • AnMed Health Cancer Center
  • CCOP - Upstate Carolina
  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
  • Welch Cancer Center at Sheridan Memorial Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 20, 2005
Last Updated
January 2, 2013
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00217659
Brief Title
S0511, Goserelin and Anastrozole in Treating Men With Recurrent or Metastatic Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Withdrawn
Why Stopped
poor accrual
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
male breast cancer, recurrent breast cancer, stage IV breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
anastrozole
Intervention Type
Drug
Intervention Name(s)
goserelin acetate
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Title
Overall survival
Title
Overall objective tumor response rate (confirmed and unconfirmed, complete and partial)
Title
Correlation of prostate specific antigen, testosterone, estradiol, estrone, estrone sulfate, follicle-stimulating hormone, luteinizing hormone, and dehydroepiandrosterone levels with PFS
Title
Toxicity

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeina Nahleh, MD
Organizational Affiliation
Barrett Cancer Center
First Name & Middle Initial & Last Name & Degree
Abdul-Rahman Jazieh, MD, MPH
Organizational Affiliation
Barrett Cancer Center
First Name & Middle Initial & Last Name & Degree
Robert B. Livingston, MD
Organizational Affiliation
University of Washington
First Name & Middle Initial & Last Name & Degree
Gabriel N. Hortobagyi, MD, FACP
Organizational Affiliation
M.D. Anderson Cancer Center
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-9181
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Colorado Cancer Center at UC Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Veterans Affairs Medical Center - Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Montrose Memorial Hospital Cancer Center
City
Montrose
State/Province
Colorado
ZIP/Postal Code
81401
Country
United States
Facility Name
Exempla Lutheran Medical Center
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Broward General Medical Center Cancer Center
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31403-3089
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Institute
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Regional Cancer Center at Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781-0001
Country
United States
Facility Name
Cancer Center of Kansas, PA - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas, PA - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Cancer Center of Kansas, PA - El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Cancer Center of Kansas, PA - Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Southwest Medical Center
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67901
Country
United States
Facility Name
Cancer Center of Kansas, PA - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Cancer Center of Kansas, PA - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
Cancer Center of Kansas, PA - Pratt
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Cancer Center of Kansas, PA - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Tammy Walker Cancer Center at Salina Regional Health Center
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Cancer Center of Kansas, PA - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates in Womens Health, PA - North Review
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Cancer Center of Kansas, PA - Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas, PA - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Via Christi Cancer Center at Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas, PA - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
Josephine Ford Cancer Center at Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
St. John's Regional Health Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
CCOP - Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Hematology-Oncology Centers of the Northern Rockies - Billings
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Northern Rockies Radiation Oncology Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
St. Vincent Healthcare
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Billings Clinic Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-5100
Country
United States
Facility Name
Deaconess Billings Clinic - Downtown
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
Bozeman Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
St. James Community Hospital
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
St. Peter's Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Glacier Oncology, PLLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Medical Oncology
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Community Medical Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59801
Country
United States
Facility Name
Guardian Oncology and Center for Wellness
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Montana Cancer Specialists at Montana Cancer Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807-7877
Country
United States
Facility Name
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807
Country
United States
Facility Name
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Rutherford Hospital
City
Rutherfordton
State/Province
North Carolina
ZIP/Postal Code
28139
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Community Oncology Group at Cleveland Clinic Cancer Center
City
Independence
State/Province
Ohio
ZIP/Postal Code
44131
Country
United States
Facility Name
Cleveland Clinic - Wooster
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
AnMed Health Cancer Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Welch Cancer Center at Sheridan Memorial Hospital
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States

12. IPD Sharing Statement

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

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