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Immune Therapy + Cryoablation for Breast Cancer
Study Summary
This trial is testing a new cancer treatment that may improve Event Free Survival rates for women with a certain type of breast cancer.
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?
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- You have taken any experimental medications within 3 weeks before starting this treatment.My cancer has not spread to distant parts of my body.I am scheduled for a total mastectomy or lumpectomy.I do not have any health or mental conditions that could make this study unsafe for me.I regularly take medication to suppress my immune system.You have an ongoing autoimmune condition that needed medication in the last 2 years.I am a woman aged 18 or older.I have a known history of HIV.I have active hepatitis B or C.I am fully active or can carry out light work.Your blood test results need to be within specific ranges for white blood cells, platelets, hemoglobin, kidney function, and liver function.My cancer has been confirmed as invasive by a pathology report.My tumor can be surgically removed and is at least 1.0 cm big.My cancer is triple-negative based on biopsy results.My cancer may or may not have spread to my lymph nodes.All areas of my breast cancer have been biopsied and are triple-negative.I am using birth control and my pregnancy test was negative.I haven't had cancer in the last 5 years, except for certain skin, cervical, or ovarian cancers.I have breast cancer in both breasts, and all tumors are triple-negative.I have been diagnosed with invasive breast cancer.I haven't had any vaccines for infectious diseases in the last 3 weeks.My tumor can be treated with freezing as decided by a radiologist.
- Group 1: Treatment Arm
- 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
What is the present size of the patient cohort for this research study?
"This clinical trial is in need of 80 qualified participants. Patients may come from any number of designated sites, including Cedars Sinai Medical Center in Los Angeles and Providence Cancer Institute in Portland."
What other research efforts have been undertaken concerning Nivolumab?
"At the present moment, 765 medical trials are in progress for Nivolumab. Of those studies, 86 are currently at Phase 3 and span 42755 different locations; most of which can be found in Pittsburgh, Pennsylvania."
For which illnesses is Nivolumab a prescribed treatment?
"Nivolumab is employed in the treatment of a variety of diseases and conditions, including but not limited to malignant neoplasms, unresectable melanoma and squamous cell carcinoma. It can also be used as an adjunct therapy following anti-angiogenic treatments."
Is recruitment still open for this research protocol?
"Affirmative. Information on clinicaltrials.gov verifies that this research endeavour, initially published on November 12th 2019, is actively seeking participants. Approximately 80 individuals need to be recruited from 3 separate facilities."
Has Nivolumab received regulatory authorization from the Federal Drug Administration?
"Nivolumab has been evaluated in Phase 2 trials and, based on our team's assessment, it was deemed to possess a safety rating of 2. This signifies that the drug had some data supporting its safety but not confirming efficacy."
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