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

SWOG Cancer Research Network

Status and phase: Withdrawn; Phase 2

Conditions: Breast Cancer

Treatments: Drug: anastrozole; Drug: goserelin acetate

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00217659

CDR0000442919

S0511 (Other Identifier)

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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