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


Phase 2
18 Years
N/A
Not Enrolling
Male
Breast Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Safety Issue:

No

Principal Investigator

Zeina Nahleh, MD

Investigator Affiliation:

Barrett Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000442919

NCT ID:

NCT00217659

Start Date:

September 2005

Completion Date:

January 2007

Related Keywords:

  • Breast Cancer
  • male breast cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • Breast Neoplasms

Name

Location

CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
University of California Davis Cancer Center Sacramento, California  95817
Great Falls Clinic Great Falls, Montana  59405
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
St. John's Regional Health Center Springfield, Missouri  65804
Broward General Medical Center Cancer Center Ft. Lauderdale, Florida  33316
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Southwest Medical Center Liberal, Kansas  67901
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Vincent Healthcare Billings, Montana  59101
Deaconess Billings Clinic - Downtown Billings, Montana  59101
Bozeman Deaconess Hospital Bozeman, Montana  59715
St. James Community Hospital Butte, Montana  59701
St. Peter's Hospital Helena, Montana  59601
Kalispell Medical Oncology Kalispell, Montana  59901
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Community Oncology Group at Cleveland Clinic Cancer Center Independence, Ohio  44131
Cleveland Clinic - Wooster Wooster, Ohio  44691
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Montrose Memorial Hospital Cancer Center Montrose, Colorado  81401
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Rutherford Hospital Rutherfordton, North Carolina  28139
AnMed Health Cancer Center Anderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Billings Clinic Cancer Center Billings, Montana  59107-5100
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045