S0511, Goserelin and Anastrozole in Treating Men With Recurrent or Metastatic Breast Cancer
This study has been withdrawn prior to enrollment.
(poor accrual)
Sponsor:
Southwest Oncology Group
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
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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) |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217659
Show 57 Study Locations
Show 57 Study LocationsSponsors 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
Additional 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 Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Goserelin Anastrozole |
Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013