Pembrolizumab in Treating Patients With Hormone Receptor Positive, Localized Inflammatory Breast Cancer Who Are Receiving Hormone Therapy and Did Not Achieve a Pathological Complete Response to Chemotherapy
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|ClinicalTrials.gov Identifier: NCT02971748|
Recruitment Status : Recruiting
First Posted : November 23, 2016
Last Update Posted : June 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Estrogen Receptor Positive Inflammatory Breast Carcinoma Progesterone Receptor Positive Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8||Biological: Pembrolizumab||Phase 2|
I. To determine the disease free survival (DFS) at 2 years of patients with maintenance therapy using pembrolizumab in combination with standard adjuvant hormonal therapy.
II. To determine the safety and toxicity profile of primary inflammatory breast cancer (IBC) patients who received combination of pembrolizumab and hormone receptor blockade.
I. To investigate the association between immune related biomarkers in the peripheral blood and tumor tissue, such as PD-L1 expression, with safety and efficacy for IBC patients treated with pembrolizumab.
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 and 24 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Anti-PD-1 (Pembrolizumab) in Combination With Hormonal Therapy During or After Radiation in Patients With Hormone Receptor (HR)-Positive Localized Inflammatory Breast Cancer (IBC) Who Did Not Achieve a Pathological Complete Response (pCR) to Neoadjuvant Chemotherapy|
|Actual Study Start Date :||January 26, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Treatment (pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
- Disease free survival (DFS) [ Time Frame: Up to 24 months ]Will be summarized with a corresponding 95% confidence interval. DFS will be compared with the historical control rate of 60% at year two by using a one-sided exponential MLE test. Cox proportional hazards regression analysis will be used to model the association between DFS and disease and demographic covariates of interest, including immune-related biomarkers in the peripheral blood and tumor tissue.
- Overall survival (OS) [ Time Frame: From the start of the study up to 24 months ]Will be summarized with a corresponding 95% confidence interval. OS will be compared with the historical control rate of 60% at year two by using a one-sided exponential MLE test. Cox proportional hazards regression analysis will be used to model the association between OS and disease and demographic covariates of interest, including immune-related biomarkers in the peripheral blood and tumor tissue.
- Incidence of adverse events [ Time Frame: Up to 1 month after last pembrolizumab dose ]Adverse events will be summarized by grade and category.
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): NCT02971748
|Contact: Bora Lim, MDemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Bora Lim 713-792-2817|
|Principal Investigator: Bora Lim|
|Principal Investigator:||Bora Lim||M.D. Anderson Cancer Center|