Phase 2
N=36
Exemestane in Treating Postmenopausal Women With Stage IV Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00810797 ↗Enrolled (actual)
36
Serious AEs
11.1%
Results posted
Sep 2020
Primary outcome: Primary: Progression-free Survival — 4.3 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- exemestane (Drug); laboratory biomarker analysis (Other); quality-of-life assessment (Procedure); immunohistochemistry staining method (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- City of Hope Medical Center
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
4.3 | — |
| SECONDARY Overall Response Rate |
8.3 | — |
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.
Eligibility 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 = = 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
Data sourced from ClinicalTrials.gov (NCT00810797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.