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Montrose, Colorado 81401

  • Breast Cancer

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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000442919


NCT ID:

NCT00217659


Secondary ID:

S0511


Study Acronym:


Brief Title:

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


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


Overall Status:

Withdrawn


Study Phase:

Phase 2


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Southwest Oncology Group


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:

poor accrual


Study Type:

Interventional


Study Design:

Masking: Open Label, Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Zeina Nahleh, MD
Barrett Cancer Center

Study Dates

Start Date:September 2005
Completion Date:January 2007
Completion Type:Actual
Primary Completion Date:January 2007
Primary Completion Type:Actual
Verification Date:January 2013
Last Changed Date:January 2, 2013
First Received Date:September 20, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Progression-free survival (PFS)
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Overall survival
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Overall objective tumor response rate (confirmed and unconfirmed, complete and partial)
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Correlation of prostate specific antigen, testosterone, estradiol, estrone, estrone sulfate, follicle-stimulating hormone, luteinizing hormone, and dehydroepiandrosterone levels with PFS
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Toxicity
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:anastrozole
Intervention Type:Drug
Name:goserelin acetate

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Southwest Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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