Loading clinical trials...
Loading clinical trials...
Intermittent Exemestane Therapy for Metastatic 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.
PRIMARY OBJECTIVES: I. Progression-free survival at 4 months, as measured by Response Evaluation Criteria in Solid Tumors (RECIST). SECONDARY OBJECTIVES: 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. TERTIARY OBJECTIVES: 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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
City of Hope Medical Center
Duarte, California, United States
South Pasadena Cancer Center
South Pasadena, California, United States
Start Date
December 2, 2008
Primary Completion Date
June 26, 2019
Completion Date
June 26, 2019
Last Updated
October 19, 2020
36
ACTUAL participants
exemestane
DRUG
laboratory biomarker analysis
OTHER
quality-of-life assessment
PROCEDURE
immunohistochemistry staining method
OTHER
Lead Sponsor
City of Hope Medical Center
Collaborators
NCT05245812
NCT04704661
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions