Clinical Trial of Atezolizumab With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03125928|
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : March 28, 2019
This is a single arm, Phase IIA clinical trial assessing the safety and efficacy of atezolizumab in combination with paclitaxel, trastuzumab, and pertuzumab in 50 patients with locally advanced, unresectable, or metastatic HER2-overexpressing breast cancer. Due to concerns that corticosteroids may have a negative effect on tumor immunity expected with addition of atezolizumab to the standard of care regimen, patients will receive premedication with dexamethasone only for weeks 1 and 2 of the weekly paclitaxel, and then corticosteroid premedication will be discontinued subsequently.
Patients must have pathologically confirmed HER2-overexpressing breast cancer that is locally recurrent, unresectable, or metastatic, with measurable disease as defined by RECIST v1.1. Tumor measurements and bone scans will be performed every 9 weeks while patients are on study.
|Condition or disease||Intervention/treatment||Phase|
|HER2-positive Breast Cancer||Drug: Atezolizumab Drug: Paclitaxel Drug: Trastuzumab Drug: Pertuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single Arm, Phase IIA Clinical Trial Assessing The Safety And Efficacy of Atezolizumab in Combination With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer|
|Actual Study Start Date :||June 13, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2022|
|Experimental: Investigational Arm||
- Number of participants with treatment-related adverse events [ Time Frame: Up to 5 years after stopping study treatment ]Treatment-related adverse events will be assessed by CTCAE v4.0
- Antitumor activity of atezolizumab plus the standard regimen of paclitaxel, trastuzumab, and pertuzumab [ Time Frame: An average of 18 weeks ]Antitumor activity will be measured by RECIST v1.1
- Overall survival (OS) [ Time Frame: Up to 5 years after the last patient stops treatment ]OS is defined as the time from initiation of treatment until death from any cause or end of the study period, whichever occurs first.
- Time to tumor progression (TTP) [ Time Frame: Up to 5 years after the last patient stops treatment ]TTP is defined as the duration of time from the start of treatment to the first objectively documented instance of progressive disease.
- Time to treatment failure (TTF) [ Time Frame: Up to 5 years after the last patient stops treatment ]TTF is defined as the duration of time from start of treatment to discontinuation of study treatment for reasons defined in the protocol.
- Progression free survival (PFS) [ Time Frame: Up to 5 years after the last patient stops treatment ]PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
- Clinical benefit rate (CBR) [ Time Frame: Up to 5 years after the last patient stops treatment ]CBR is defined as the rates of complete response (CR), partial response (PR) and stable disease (SD).
- Duration of response (DOR) [ Time Frame: Up to 5 years after the last patient stops treatment ]Per RECIST v1.1, DOR will be assessed by the duration of overall response, duration fo CR/PR, and duration of SD.
- Correlation of biomarkers related to PD-L1 blockade with objective response rate (ORR), CBR, PFS, OS, and DOR. [ Time Frame: Up to 5 years after the last patient stops treatment ]Efficacy will be assessed according to tumor PD-L1 expression level and tumor infiltrating lymphocytes PD-L1 expression levels.
- Efficacy according to hormone receptor status (ER/PR) [ Time Frame: Up to 5 years after the last patient stops treatment ]This will be a future subset analysis.
- Feasibility of discontinuation of corticosteroids use after 2 weekly doses of paclitaxel [ Time Frame: Up to 5 years after the last patient stops treatment ]This will be assessed by CTCAE v4.0.
- Rate of occurrence of paclitaxel-related infusion hypersensitivity reaction after discontinuation of corticosteroids [ Time Frame: An average of 18 weeks ]This will be assessed by CTCAE v4.0.
- Cardiac safety [ Time Frame: An average of 18 weeks ]Quarterly MUGA or ECHO results assessing occurrence of left ventricular dysfunction.
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): NCT03125928
|Contact: Lori J Goldstein, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|Fox Chase Cancer Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19111|
|Contact: Lori J Goldstein, MD 215-214-1515 email@example.com|