- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04333706
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)
Study Overview
Status
Conditions
Detailed Description
The study will consist of two phases, I and II.
Phase I 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. Blood samples will be obtained prior during the course of treatment. Bone marrow samples are optional.
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. Blood samples will be obtained prior during the course of treatment. Bone marrow samples are optional.
A pilot parallel biological baseline study of standard adjuvant capecitabine in stage I to III TNBC with less than a pCR will be performed. This Arm will be open in parallel with both Phases 1 and 2. Blood samples will be obtained prior during the course of treatment. Bone marrow samples are optional.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Kimberly Arieli, RN
- Phone Number: 323-865-3935
- Email: Kimberly.Arieli@med.usc.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90033
- Recruiting
- USC/Norris Comprehensive Cancer Center
-
Principal Investigator:
- Priya Jayachandran, MD
-
Contact:
- Kimberly Arieli, RN
- Phone Number: 323-865-3935
- Email: Kimberly.Arieli@med.usc.edu
-
Los Angeles, California, United States, 90033
- Recruiting
- Los Angeles General Medical Center
-
Principal Investigator:
- Priya Jayachandran, MD
-
Contact:
- Kimberly Arieli, RN
- Phone Number: 323-865-3935
- Email: Kimberly.Arieli@med.usc.edu
-
-
Florida
-
Gainesville, Florida, United States, 32610
- Active, not recruiting
- UF Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- A. Written informed consent obtained from the subject and the ability for the subject to comply with all the study-related procedures.
- B. Both males and females ≥ eighteen years of age
- C. A clinical diagnosis of metastatic triple negative or hormone resistant, Her2/neu-negative breast cancer that has been confirmed histologically at one point during the course of the disease. TNBC is defined as ER/PR IHC positivity rate of <10% and Her2Neu-negative (Phase I only)
- D. A life expectancy of at least 6 months. (Phase I only)
- E. Any previous cytotoxic chemotherapy must have been a minimum of 3 weeks prior to study drug administration. There is no limit on the number of prior therapies. For ER/PR-positive tumors, endocrine therapy must have been included in at least one of those prior regimens. Prior capecitabine is allowed only if not given in the treatment regimen immediately prior to the enrollment in this study. (Phase I only)
- F. A diagnosis of TNBC confirmed histologically and defined as ER/PR IHC positivity rate of <10% and Her2/neu-negative. (Phase II and Parallel Baseline Arm only)
- G. A pathologic confirmation of stage I, or II, or III breast cancer with less than a complete pCR, defined as the absence of residual invasive cancer in resected breast specimen and sampled lymph nodes with residual noninvasive cancer or in situ disease allowed. (Phase II and Parallel Baseline Arm only)
- H. Must not have received prior systemic treatment for breast cancer except for those included in the neoadjuvant regimen and the neoadjuvant regimen must not have included capecitabine nor sarilumab. (Phase II and Parallel Baseline Arm only)
- I. An ECOG Performance Status ≤2.
J. Adequate organ function defined as:
- Absolute neutrophil count (ANC) > 1500/mcl (use of G-CSF is allowed)
- Platelets ≥ 100,000/mcl
- Hemoglobin ≥ 9 (pRBC +/- ESA are allowed)
- ALT ≤ 5 x ULN
- AST ≤ 5 x ULN
- Bilirubin ≤ 3 x ULN
- GFR ≥ 30 ml/min
- K. Women of childbearing potential (WOCBP) must be using a highly effective method of contraception to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug to minimize the risk of pregnancy. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
- L. Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug.
Exclusion Criteria:
- A. Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 24 weeks after the last dose of study drug.
- B. Females who are pregnant or breastfeeding.
- C. History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
- D. Hepatitis B infection except for prior vaccination. (Phase I and Phase II only).
- E. Known history of tuberculosis injection. (Phase I and Phase II only).
- F. A history of diverticulitis. (Phase I and Phase II only).
- G. Use of live vaccines within 30 days prior to study treatment due to the risk of infection. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella (MMR), varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed. (Phase I and Phase II only)
- H. History of other malignancy that in the primary oncologist's estimation has at the time of study participation a higher risk of recurrence or death than the study-related cancer.
- I. Prisoners or subjects who are involuntarily incarcerated.
- J. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
- K. Subjects demonstrating an inability to comply with the study and/or follow-up procedures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: Phase I
A dose finding study of sarilumab plus capecitabine in patients with metastatic TNBC and metastatic HER2/neu-negative and hormone resistant breast cancer.
|
Sarilumab 150mg or 200 mg plus Capecitabine 1000 mg BID
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
|
Sarilumab 150mg or 200 mg plus Capecitabine 1000 mg BID
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.
|
Other: Parallel Baseline Arm
Study of standard adjuvant capecitabine in stage I to III TNBC with less than a pCR.
This Arm will be open in parallel with both Phases 1 and 2. Blood samples will be obtained during the course of the study.
Bone marrow samples are optional.
|
Capecitabine 1000 mg BID
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
first treatment up to 9 weeks
|
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:
|
first treatment up to 9 weeks
|
Phase II:To determine the percent of patients with positive CTCs and DTCs (if available) becoming negative CTCs and DTCs (if available) after treatment
Time Frame: baseline up to 14 weeks
|
Bone marrow aspirates will be performed before treatment and at defined time points during treatment.
|
baseline up to 14 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Priya Jayachandran, MD, University of Southern California
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1B-22-3
- 1R01CA238387-01A1 (U.S. NIH Grant/Contract)
- HS-23-00019 (Other Identifier: USC IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
Clinical Trials on Sarilumab 150mg or 200 mg plus Capecitabine
-
Novartis PharmaceuticalsRecruitingNon-Small Cell Lung CarcinomaIndia
-
Maimónides Biomedical Research Institute of CórdobaConsejería de Salud y Familias - Junta de Andalucía; Red Andaluza de Ensayos...Completed
-
Instituto de Investigación Marqués de ValdecillaUnknownRheumatoid Arthritis | Atherosclerosis
-
Marius HenriksenTerminatedCorona Virus DiseaseDenmark
-
Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.R&G Pharma Studies Co.,Ltd.CompletedHealthy Chinese VolunteersChina
-
Yale UniversityUniversity of Colorado, Denver; Eunice Kennedy Shriver National Institute of... and other collaboratorsActive, not recruitingInfertility | EndometriosisUnited States
-
Yale UniversityJohns Hopkins University; University of Colorado, Denver; Northwestern University and other collaboratorsRecruitingInfertility | EndometriosisUnited States
-
Fudan UniversityNot yet recruitingColorectal Cancer | Colorectal Cancer Stage IV
-
German Breast GroupCompletedMetastatic Breast CancerGermany
-
Hoffmann-La RocheCompletedChronic Hepatitis CUnited States, Puerto Rico