Exemestane and Cyclophosphamide for Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01963481|
Recruitment Status : Completed
First Posted : October 16, 2013
Last Update Posted : October 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Beast Cancer||Drug: Exemestane Drug: Cyclophosphamide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Exemestane With Immunomodulatory Cyclophosphamide in ER and/or PR-positive and HER2/Neu Negative Metastatic Breast Cancer|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||October 1, 2017|
|Actual Study Completion Date :||October 1, 2017|
Experimental: Exemestane and cyclophosphamide
A treatment cycle is defined as 4 weeks:
One tablet (25 mg) of exemestane and one tablet (50 mg) of cyclophosphamide given daily by mouth until disease progression or unacceptable adverse events.
Other Name: Aromasin
- Progression-free survival (PFS) rate at 3 months [ Time Frame: 3 months ]PFS is defined as the time from first treatment day until objective disease progression or death from any cause. Assessment of disease progression based on Response Evaluation Criteria in Solid Tumor (RESIST) guideline version 1.1 is performed every 12 weeks on study.
- Response rate (complete response and partial response) [ Time Frame: 2 years ]Evaluation of response is based on RESIST guideline version 1.1. Response is assessed every 12 weeks.
- Clinical benefit rate [ Time Frame: 3 years ]Clinical benefit rate is defined as the percentage of patients who have achieved objective response or stable disease for at least 24 weeks. Evaluation of response and disease progression is based on RESIST guideline version 1.1. Response and progression are assessed every 12 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01963481
|United States, New York|
|NYU Cancer Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Sylvia Adams, MD||NYU Perlmutter Cancer Center|