Overview

Exemestane in Treating Postmenopausal Women With Stage IV Breast Cancer

Status:
Completed
Trial end date:
2019-06-26
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
City of Hope Medical Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Exemestane
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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