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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 CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
University of California Davis Cancer CenterSacramento, California  95817
Great Falls ClinicGreat Falls, Montana  59405
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
St. John's Regional Health CenterSpringfield, Missouri  65804
Broward General Medical Center Cancer CenterFt. Lauderdale, Florida  33316
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Southwest Medical CenterLiberal, Kansas  67901
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Community Oncology Group at Cleveland Clinic Cancer CenterIndependence, Ohio  44131
Cleveland Clinic - WoosterWooster, Ohio  44691
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Montrose Memorial Hospital Cancer CenterMontrose, Colorado  81401
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Rutherford HospitalRutherfordton, North Carolina  28139
AnMed Health Cancer CenterAnderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Billings Clinic Cancer CenterBillings, Montana  59107-5100
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045