Intermittent Exemestane Therapy for Metastatic Breast Cancer
- To determine the progression-free survival at 4 months, as measured by RECIST criteria,
in postmenopausal women with stage IV breast cancer treated with exemestane.
- To determine the objective response rate (complete response [CR] and partial response
[PR]) in these patients.
- To determine the clinical benefit of this drug, in terms of CR, PR, and stable disease
for ≥ 6 months, in these patients.
- To assess the toxicity of this drug in these patients.
- To assess patient compliance with medication adherence.
- To assess quality of life of these patients.
- To assess bone health of these patients.
- Serial measurements of serum estradiol, estrone, and estrone sulfate.
- To investigate potential biomarkers of treatment response (e.g. Ki67, mitogen-activated
protein kinase [MAPK], phosphorylated Akt [p-Akt]) and treatment resistance using
molecular and immunohistochemical analyses of blood and tumor samples of pre and post
(when available) treatment tissues. Microarray analyses to quantitate the expression of
specific estrogen-responsive genes (e.g. thyroid transcription factor 1 [TTF1] and
PDZk1) will also be performed.
OUTLINE: Patients receive oral exemestane once daily on days 1-14. Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity.
Patients complete EORTC QLQ-C30 questionnaires on day 1 of each treatment course.
Blood samples are collected on days 1 and 15 of each treatment course for quantitation of
serum estrogen levels (estradiol, estrone, and estrone sulfate).
After completion of study therapy, patients are followed periodically for 1 year.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival at 4 months
4 months after the start of treatment
Thehang Luu, MD
City of Hope Medical Center
United States: Institutional Review Board
|City of Hope Medical Center||Duarte, California 91010|