Clinical trial · Interventional
S0511, Goserelin and Anastrozole in Treating Men With Recurrent or Metastatic Breast Cancer
A Phase II Study of Goserelin Plus Anastrozole for the Treatment of Male Patients With Hormone-Receptor Positive Metastatic or Recurrent Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anastrozole | Drug | Anastrozole | ALIAS |
| goserelin acetate | Drug | Goserelin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Progression-free survival (PFS)
- measure
- Overall survival
- measure
- Overall objective tumor response rate (confirmed and unconfirmed, complete and partial)
- measure
- Correlation of prostate specific antigen, testosterone, estradiol, estrone, estrone sulfate, follicle-stimulating hormone, luteinizing hormone, and dehydroepiandrosterone levels with PFS
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 CharacteristicsReferences
Publications (0)
Data not yet available