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Nivolumab + Chemotherapy + Endocrine Therapy for Breast Cancer (CheckMate 7FL Trial)
CheckMate 7FL Trial Summary
This trial is testing if adding the immunotherapy drug nivolumab to neoadjuvant and adjuvant chemotherapy and endocrine therapy can help treat high-risk ER+, HER2- early stage breast cancer.
CheckMate 7FL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCheckMate 7FL Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CheckMate 7FL Trial Design
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Who is running the clinical trial?
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- You have a type of breast cancer that tests positive for estrogen receptor, and may or may not have progesterone receptor.You have more than one tumor in different parts of your breast.You have received treatment with certain types of drugs that affect the immune system's ability to fight cancer.Cancer has spread in both breasts.Your local lab test shows that you do not have the HER2- breast cancer gene.Your tumor is a certain grade and has a specific level of a protein called ER.You have invasive breast ductal carcinoma that is a certain size and has spread to nearby lymph nodes. The lymph node status must be confirmed by a specific type of biopsy.You have had cancer in one breast or both breasts before.You should be in good physical shape, with little or no impact on your daily activities due to your health.There is clear evidence that the cancer has spread to other parts of the body.Your heart is not pumping well or you have severe heart disease.
- Group 1: Arm B: Placebo combined with neoadjuvant CT and then adjuvant ET
- Group 2: Arm A: Nivolumab combined with neoadjuvant CT and adjuvant ET
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Are there long-term repercussions to nivolumab treatments?
"There is a significant volume of data supporting the safety of nivolumab, so it received a score of 3."
How does nivolumab compare to other treatments in clinical trials?
"Nivolumab is being trialled in 2334 concurrent studies, with 433 of those in Phase 3. Most of these investigations are based in Ciudad de Mexico and Maryland, though there are 98491 clinical trial centres spread out across the globe."
What are some of the conditions that nivolumab has been shown to be most effective in treating?
"Nivolumab is a cancer medication that can be used to treat metastatic urothelial carcinoma, as well as other diseases such as metastatic hepatocellular carcinoma, malignant melanoma of skin, and leukemia."
Can additional people still enroll in this research project?
"No, this study is not currently looking for volunteers. However, according to the data on clinicaltrials.gov, this study was last edited on 10/31/2022. Additionally, while this specific study might not be recruiting right now, there are 5017 other clinical trials that are."
How many patients will be allowed to enroll in this clinical trial?
"This study is not currently looking for patients. The trial was originally posted on 20 November 2019 but was last edited on 31 October 2020. There are 2683 trials actively searching for patients with breast cancer and 2334 trials for nivolumab that are still recruiting patients."
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