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New treatment option for Breast
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)
ClinicalTrials.gov ID: NCT04333706
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, being studied as a potential treatment for breast.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study looks to advance a novel and potent strategy to eliminate minimal residual disease (MRD) in triple negative breast cancer (TNBC) present even after multimodal treatment, thereby improving survival and increasing cure rate in this aggressive cancer. Patients with locally advanced TNBC are at high risk of developing lethal metastatic disease within 2 years of diagnosis, especially for those without a pathologic complete response (pCR) after neoadjuvant chemotherapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- 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...
- 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).
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 people who are involuntarily incarcerated.
- J. people who are compulsorily detained for treatment of either a psychiatric or physical illness.
- K. people demonstrating an inability to comply with the study and/or follow-up procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Gainesville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.