Exemestane in Treating Postmenopausal Women With Stage IV Breast Cancer
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.
Other: laboratory biomarker analysis
Procedure: quality-of-life assessment
Other: immunohistochemistry staining method
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intermittent Exemestane Therapy for Metastatic Breast Cancer|
- Progression-free survival measured by RECIST [ Time Frame: 4 months after the start of treatment ] [ Designated as safety issue: No ]Reported using the method of Kaplan-Meier.
- Objective response [ Time Frame: Assessed up to 1 year ] [ Designated as safety issue: No ]
- Toxicity as assessed by NCI CTCAE version 3.0 [ Time Frame: Assessed up to 1 year ] [ Designated as safety issue: Yes ]
- Compliance with medication adherence [ Time Frame: Assessed up to 1 year ] [ Designated as safety issue: No ]Patients will be supplied with a calendar of the treatment schedule and will be instructed to track their daily consumption of exemestane at home.
- Quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 [ Time Frame: On day 1 of each treatment course ] [ Designated as safety issue: No ]This instrument consists of a 30-item, cancer-specific tool which encompasses measures of physical, emotional, cognitive, and social well being, in addition to measures of symptoms and overall quality of life.
- Bone health [ Time Frame: 21 days after the start of the last course of treatment ] [ Designated as safety issue: No ]
- Serum hormone levels [ Time Frame: 21 days after the start of the last course of treatment ] [ Designated as safety issue: No ]
- Expression of amphiregulin and EGFR using molecular and immunohistochemical analyses of blood and tumor samples [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Expression of specific estrogen-responsive genes (TTF1 and PDZk1) [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (exemestane)
Patients receive oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Given orallyOther: laboratory biomarker analysis
One year after completion of study treatmentProcedure: quality-of-life assessment
One year after completion of study treatmentOther: immunohistochemistry staining method
Other Name: immunohistochemistry
I. Progression-free survival at 4 months, as measured by Response Evaluation Criteria in Solid Tumors (RECIST).
I. Objective response rate (complete response [CR] and partial response [PR]).
II. Clinical benefit (CR, PR, and stable disease >= 6 months).
III. Assessment of toxicity.
IV. Assessment of compliance with medication adherence.
V. Assessment of quality of life.
VI. Assessment of bone health.
I. Serial measurements of serum estradiol, estrone, and estrone sulfate.
II. To investigate treatment resistance (e.g., expression of amphiregulin, epidermal growth factor receptor [EGFR]), 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 exemestane orally (PO) once daily (QD) on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically for 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810797
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010-3000|
|South Pasadena Cancer Center|
|South Pasadena, California, United States, 91030|
|Principal Investigator:||George Somlo, MD||City of Hope Medical Center|