Neoadj ph 2 AI Plus Everolimus in Postmenopausal Women w/ ER Pos/HER2 Neg, Low Risk Score
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|ClinicalTrials.gov Identifier: NCT02236572|
Recruitment Status : Unknown
Verified December 2016 by Yale University.
Recruitment status was: Active, not recruiting
First Posted : September 10, 2014
Last Update Posted : March 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Everolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Neoadjuvant Phase II Trial of Aromatase Inhibitors in Combination With Everolimus in Postmenopausal Women With Hormone Receptor Positive/HER2 Negative Breast Cancers With Low and Intermediate Risk (< 25) Oncotype Dx Recurrence Scores|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||September 2018|
Experimental: Aromatase Inhibitor plus Everolimus
Aromatase inhibitor plus everolimus by mouth daily for 26 weeks
Aromatase inhibitor plus everolimus by mouth daily for 26 weeks. All patients will begin treatment on Cycle 1 Day 1 with both the standard dose of one of the following 3 aromatase inhibitors ( physician's choice) plus everolimus 10 mg by mouth daily:
- Achievement of a PEPI score of 0 following neoadjuvant treatment with everolimus and an aromatase inhibitor [ Time Frame: up to 26 weeks ](PEPI) preoperative endocrine prognostic index. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and estrogen receptor status of the surgical specimen. An HR in the range of 1-2 receives one risk point; a HR in the 2-2.5 range, two risk points; a HR greater than 2.5, three risk points. The total risk point score for each patient is the sum of all the risk points accumulated from the four factors in the model.
- Participant ability to tolerate study treatment with minimal side effects [ Time Frame: assessed up to 30 days after completion of study treatment ]Adverse events that begin or worsen after informed consent will be recorded. Adverse event monitoring should be continued for at least 30 days following the last dose of treatment.
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): NCT02236572
|United States, Connecticut|
|New Have, Connecticut, United States, 06520|
|Principal Investigator:||Lajos Pusztai, MD||Yale University|