Exemestane in Treating Postmenopausal Women With Stage IV Breast Cancer
Completed · Phase 2
Conditions studied: Breast Cancer
In brief
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body makes. PURPOSE: This phase II trial is studying how well exemestane works in treating postmenopausal women with stage IV breast cancer.
Key facts
- Study ID
- NCT00810797
- Run by
- City of Hope Medical Center
- People needed
- 36
- Starts
- 2008-12-02
- Expected to finish
- 2019-06-26
- Last updated by the study team
- 2020-10-19
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed metastatic carcinoma of the breast
- Hormone receptor (estrogen receptor [ER] and/or progesterone receptor [PR]) positive disease (defined as: ER and/or PR positivity as >= 5% staining), as confirmed by immunohistochemistry (IHC) based on primary breast tissue or metastatic tissue
- Postmenopausal, as defined by any of the following:
- Natural menopause, with at least 1 year since last menses
- Chemotherapy-induced menopause with at least 1 year from last menses and serum luteinizing hormone (LH)/follicle-stimulating hormone (FSH) and estradiol levels within the postmenopausal range
- History of surgical or radiation-induced ovarian ablation
- For women =< 56 years old and with a history of hysterectomy but at least one ovary intact, serum LH/FSH and estradiol levels must be within the postmenopausal range
- Postmenopausal women with disease recurrence while receiving either tamoxifen or a non-steroidal aromatase inhibitor (AI) as adjuvant therapy (as long as adjuvant hormonal therapy was taken for 6 months before disease progression) or with disease recurrence following the discontinuation/completion of adjuvant hormonal therapy
- Postmenopausal women with disease progression following either 0, 1 or 2 prior hormonal therapies for metastatic breast cancer, as long as the subject has had no prior exposure to exemestane (EXE)
- Measurable or non-measurable (but evaluable) disease, as defined by RECIST criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Neutrophil count >= 1.5 X 10\^9 cells/L
- Platelet count >= 100 X 10\^9 cells/L
- Serum creatinine =< 1.5 times upper limit of normal (ULN)
- Total serum bilirubin =< 1.5 times ULN
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels =< 2.5 x ULN in patients without liver metastases or =< 5 times ULN in patients with liver metastases
- Alkaline phosphatase =< 2.5 times the ULN for patients without bone or liver metastases
- Subjects must have an estimated life expectancy of greater than 6 months
You may not qualify if…
- Prior exposure to EXE, whether in the adjuvant or metastatic setting
- Prior history of any other cancer with the exception of non-melanoma skin cancer and treated in situ carcinoma of the cervix
- Active or symptomatic central nervous system (CNS) metastasis (stable or treated brain metastasis allowed but patients must be off decadron, if given for CNS disease)
- Hormone-receptor negative or unknown breast cancer
- More than two prior chemotherapy regimen for treatment of metastatic disease (any prior chemotherapy given in the adjuvant setting is permitted)
- Administration of any other anti-cancer therapy within 2 weeks of initiating study treatment; use of bisphosphonates, however, are permitted for patients with known bone metastases
- Treatment with any other concurrent investigational agent or anti-tumor drug (chemotherapy, antibody therapy or other biologic agents), will not be permitted
- Subjects who have had no prior exposure to endocrine therapy
- Any uncontrolled medical co-morbidity or psychiatric disorder which interferes with the ability to provide informed consent or comply with study procedures
Where it is running
- City of Hope Medical Center — Duarte, California, United States
- South Pasadena Cancer Center — South Pasadena, California, United States
Full record on ClinicalTrials.gov
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