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

This study has been withdrawn prior to enrollment.
(poor accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00217659
First received: September 20, 2005
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: anastrozole
Drug: goserelin acetate
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Overall objective tumor response rate (confirmed and unconfirmed, complete and partial) [ Designated as safety issue: No ]
  • Correlation of prostate specific antigen, testosterone, estradiol, estrone, estrone sulfate, follicle-stimulating hormone, luteinizing hormone, and dehydroepiandrosterone levels with PFS [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: September 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217659

  Show 57 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Investigator: Zeina Nahleh, MD Barrett Cancer Center
Investigator: Abdul-Rahman Jazieh, MD, MPH Barrett Cancer Center
Investigator: Robert B. Livingston, MD University of Washington
Investigator: Gabriel N. Hortobagyi, MD, FACP M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00217659     History of Changes
Other Study ID Numbers: CDR0000442919, S0511, U10CA032102
Study First Received: September 20, 2005
Last Updated: January 2, 2013
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
male breast cancer
recurrent breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Anastrozole
Goserelin
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014