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Niraparib + Dostarlimab for Breast Cancer
Study Summary
This trial is studying how well a combination of two drugs works in treating patients with breast cancer that has spread to other parts of the body and have certain genetic mutations
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- My cancer is ER and PR positive and HER2 negative, tested in a certified lab.I am allergic to medications similar to niraparib or dostarlimab.My organs and bone marrow are functioning well.Your breast imaging should also include pictures of the armpit on the same side.My cancer is estrogen or progesterone receptor positive.My cancer's estrogen and progesterone receptor status has been tested.You have an autoimmune disease that needed strong medication in the last 2 years.I have received treatments like chemotherapy or radiation for my current breast cancer.I have no history of cancer, or it was a specific exception.I have had interstitial lung disease or pneumonitis.I have not received a live vaccine in the last 2 weeks.I have a harmful genetic change in BRCA1, BRCA2, or PALB2.I can swallow and keep down pills.I have a history of MDS or AML.I have not had a blood transfusion in the last 4 weeks.My breast cancer is confirmed and the tumor is at least 1.5 cm big.My cancer is not driven by estrogen or progesterone.My breast cancer is confirmed, not inflammatory, and the largest tumor is at least 1.5 cm.I have had a biopsy or lymph node removal before starting the study treatment.I am 18 years old or older.My cancer has low HER2 levels according to tests.My breast cancer is at stage IV.You need to have medical tests done within a certain time frame before starting the study. Blood tests must be done within 14 days before signing up, and diagnostic imaging, like MRIs or CT scans, must be done within 28 days before starting treatment.My tumor is HER2-negative as per the tests.I have not had major surgery in the last 3 weeks.I am fully active or can carry out light work.I do not have any severe illnesses that are not under control.I have a harmful BRCA1, BRCA2, or PALB2 gene mutation confirmed by a certified lab.I have not taken steroids or immunosuppressants in the last 7 days.I am having a lumpectomy and can safely receive radiation therapy.I have multiple cancer sites, but at least one meets the study's requirements.If you have a small HER2+ tumor in addition to a target lesion, you may still be able to join the study if the main investigator agrees and the sponsor-investigator gives permission.I can swallow and keep down pills.I agree to have two biopsies: one now and another after 3 weeks of treatment.People with HIV may join the study if they meet certain conditions.I have Hepatitis B or C but meet specific health criteria.
- Group 1: Arm A Triple Negative Breast Cancer (TNBC)
- Group 2: Arm C ER+/HER2-
- Group 3: Arm B TNBC
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Could you please provide a tally of how many different hospitals are managing this trial?
"At the moment, this clinical trial is recruiting patients from 7 different sites. These locations include Baltimore, Rochester and Boston among others. If you enroll in the study, it would be beneficial to select a location close to minimize travel requirements."
Could you provide more information on Niraparib research?
"Niraparib is being studied in 112 different active clinical trials, 14 of which are Phase 3. The majority of Niraparib studies are based out of Washington D.C., however there are 3147 locations worldwide where patients can receive this treatment as part of a clinical trial."
What are the main therapeutic benefits of Niraparib?
"Niraparib is most commonly used to treat primary peritoneal cancer, but it can also be taken to treat advanced mismatch repair-deficient (dmmr) endometrial cancer, disease that has progressed during or following platinum-containing chemotherapy, and fallopian tubes cancer."
Is this clinical trial still enrolling new patients?
"Yes, the trial is recruiting patients as of today. According to the information on clinicaltrials.gov, the trial was posted on December 18th 2020 and last updated on November 11th 2022. The study requires 62 participants in total, which will be recruited from 7 locations."
What is the intent of this experiment?
"The aim of this 18-week clinical trial is to study the efficacy of Tumor-infiltrating lymphocytes (TILs). Additionally, researchers will investigate how Changes in TILs affects patients' responses to treatment using a two-sample Wilcoxon rank sum test and logistic regression model. Finally, they hope to determine the Rate of Residual Cancer Burden (RCB) 0/1 response and Number of Participants With Treatment-Related NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0."
Are there any safety concerns to be aware of before taking Niraparib?
"Niraparib's safety is based on preliminary data from Phase 2 trials, meaning that while there are no guarantees of efficacy, the medication appears to be safe."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Vanderbilt-Ingram Cancer Center: < 24 hours
- Mayo Clinic: < 24 hours
- Beth Israel Deaconess Medical Center: < 24 hours
Average response time
- < 1 Day
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