Exemestane in Treating Postmenopausal Women With Stage IV Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00810797|
Recruitment Status : Active, not recruiting
First Posted : December 18, 2008
Last Update Posted : January 30, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: exemestane Other: laboratory biomarker analysis Procedure: quality-of-life assessment Other: immunohistochemistry staining method||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intermittent Exemestane Therapy for Metastatic Breast Cancer|
|Actual Study Start Date :||December 2, 2008|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
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
- Progression-free survival measured by RECIST [ Time Frame: 4 months after the start of treatment ]Reported using the method of Kaplan-Meier.
- Objective response [ Time Frame: Assessed up to 1 year ]
- Toxicity as assessed by NCI CTCAE version 3.0 [ Time Frame: Assessed up to 1 year ]
- Compliance with medication adherence [ Time Frame: Assessed up to 1 year ]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 ]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 ]
- Serum hormone levels [ Time Frame: 21 days after the start of the last course of treatment ]
- Expression of amphiregulin and EGFR using molecular and immunohistochemical analyses of blood and tumor samples [ Time Frame: Up to 1 year ]
- Expression of specific estrogen-responsive genes (TTF1 and PDZk1) [ Time Frame: Up to 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|