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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
Not Enrolling
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


- 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


- 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



- 18 and over


- Male

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- Not specified


- No evidence of severe or uncontrolled hepatic disease


- No evidence of severe or uncontrolled renal disease


- No evidence of severe or uncontrolled cardiac disease


- No evidence of severe or uncontrolled respiratory disease


- 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


Biologic therapy

- No concurrent prophylactic filgrastim (G-CSF) or other hematopoietic growth factors


- 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

- No other concurrent hormonal therapy (e.g., estrogen-based therapies)


- See Disease Characteristics

- At least 14 days since prior radiotherapy for this cancer and recovered

- No concurrent radiotherapy


- See Disease Characteristics

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Safety Issue:


Principal Investigator

Zeina Nahleh, MD

Investigator Affiliation:

Barrett Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 2005

Completion Date:

January 2007

Related Keywords:

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



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