A Dose Finding Phase 1 of Sarilumab Plus Capecitabine in HER2/Neu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab Plus Capecitabine in Stage I-III Triple Negative Breast Cancer With High-Risk Residual Disease (EMPOWER) (EMPOWER)
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|ClinicalTrials.gov Identifier: NCT04333706|
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : May 3, 2022
|Condition or disease||Intervention/treatment||Phase|
|Breast Metastatic Triple Negative Cancer Disseminated Tumor Cell||Drug: Capecitabine Combination Product: Sarilumab 150mg or 200 mg plus Capecitabine Combination Product: Sarilumab 150mg plus Capecitabine||Phase 1 Phase 2|
The study will consist of two phases, I and II. Phase I will be made up of 2 patient cohorts, Cohorts A and B.
- Cohort A, will include Stage I to III TNBC patients with less than a complete pCR after neoadjuvant therapy who will be treated with capecitabine (1000mg/m2/BID; for 14 days every 21 days) as standard of care. This cohort will be used to determine baseline bone marrow disseminated tumor cells (BM DTC) response to capecitabine alone.
- Cohort B, will include patients with metastatic TNBC, HER2/neu-negative and hormone resistant breast cancer. A total of 4 doses of sarilumab will be given with the starting dose of 150 mg SQ at 3-weeks cycles given 3 days prior to each of the first 4 of 8 cycles of capecitabine (1000 mg/m2/BID; for 14 days every 21 days). If dose escalation is possible, sarilumab will be administered every 3 weeks at 200 mg SQ for 4 doses.
Phase II is a single arm study in Stage I to III TNBC with less than a complete pCR after neoadjuvant therapy evaluating the combination of sarilumab with capecitabine (1000mg/m2/BID; for 14 days every 21 days) as compared to historical control patients treated with capecitabine alone. There are 8 cycles of capecitabine. The first 4 cycles will be combined with sarilumab. The Phase II sarilumab dose will be determined by the Phase I best tolerated dose. In patients without bone marrow DTC clearance after 4 doses of sarilumab, 4 more doses of sarilumab will be given in combination with the last 4 cycles of capecitabine.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Dose Finding Phase 1 of Sarilumab Plus Capecitabine in HER2/Neu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab Plus Capecitabine in Stage I-III Triple Negative Breast Cancer With High-Risk Residual Disease (EMPOWER)|
|Actual Study Start Date :||September 26, 2020|
|Estimated Primary Completion Date :||September 26, 2025|
|Estimated Study Completion Date :||September 26, 2029|
Experimental: Experimental Phase 1: Cohort A
To determine the status of Disseminated Tumor Cell (DTC) in bone marrow aspirate before and after adjuvant capecitabine only to establish the baseline response rate of bone marrow (BM) Disseminated Tumor Cell (DTC) to capecitabine alone.
Capecitabine 1000 mg BID
Experimental: Experimental: Phase I: Cohort B
A dose finding study of sarilumab plus capecitabine in patients with metastatic TNBC and metastatic HER2/neu-negative and hormone resistant breast cancer.
Combination Product: Sarilumab 150mg plus Capecitabine
Dose escalation schedule of sarilumab. The starting dose for sarilumab is 150 mg SQ every 21 days, given 3 days prior to the first 4 of 8 cycles of capecitabine 1000 mg BID.
Experimental: Phase 2 single arm study
Study of adjuvant sarilumab plus capecitabine in stage I to III TNBC with less than a pCR
Combination Product: Sarilumab 150mg or 200 mg plus Capecitabine
Sarilumab 150mg or 200 mg plus Capecitabine 1000 mg BID
- Phase I: Maximum Tolerated Dose (MTD) [ Time Frame: first treatment up to 9 weeks ]Establish MTD of sarilumab plus capecitabine in patients with metastatic TNBC and metastatic HER2/neu-negative and hormone resistant breast cancer
- Phase I: Dose-limiting toxicity (DLT) [ Time Frame: first treatment up to 9 weeks ]Defined events that are possibly, probably, or definitely related to the study treatment:
- Phase II:To determine the percent of patients with positive DTC becoming negative DTCs after treatment [ Time Frame: baseline up to 14 weeks ]Bone marrow aspirates will be performed before treatment and at defined time points during 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): NCT04333706
|Contact: Victoria Hopefirstname.lastname@example.org|
|United States, Florida|
|Gainesville, Florida, United States, 32610|
|Contact: Danielle Ogden 352-265-0680 email@example.com|
|Principal Investigator: Karen Daily, DO|
|University Of Florida College of Medicine - Jacksonville||Recruiting|
|Jacksonville, Florida, United States, 32209|
|Contact: Katrina Maloney 904-633-0177 firstname.lastname@example.org|
|Principal Investigator: Bharatsinh Gharia, MD|
|Principal Investigator:||Karen Daily, DO||University of Florida|
|Study Director:||David Tran, MD, PhD||University of Florida|