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Pembrolizumab + Chemotherapy for Breast Cancer
Study Summary
This trial will study the safety of giving pembrolizumab with either paclitaxel or capecitabine to people with triple negative breast cancer that has spread and cannot be removed by surgery.
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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- I am at least 18 years old.You are allergic to pembrolizumab or any of its ingredients.I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks, except for Denosumab.I haven't had cancer treatment in the last 2 weeks or still have side effects, except for mild neuropathy or hair loss.I have a history of active tuberculosis.You currently have Hepatitis B or Hepatitis C that is not under control.I have not received a live vaccine in the last 30 days.My breast cancer is HER2-negative.My breast cancer is not driven by estrogen or progesterone.My cancer can't be removed by surgery and its size can be measured.I am fully active or restricted in physically strenuous activity but can do light work.I have not taken steroids or immunosuppressants in the last 7 days.My organ functions are within normal ranges as required.I must avoid pregnancy or fathering a child while on treatment.I have previously received the specified chemotherapy for my cancer.I have stable brain metastases and haven't used steroids in the last 7 days.I am eligible for treatment with paclitaxel or capecitabine as my first or second chemotherapy.I agree to provide a recent biopsy sample or use an old one if I haven't had cancer treatment since it was taken.I have fully recovered from any major surgery before starting treatment.I have another cancer that has worsened or needed treatment in the past 5 years.I have been treated for an autoimmune disease in the last 2 years.I have or had lung inflammation or disease needing steroid treatment.I am currently being treated for an infection.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2, or was in a pembrolizumab study.I have been diagnosed with HIV.
- Group 1: Arm A
- Group 2: Arm B
- 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 therapeutic conditions are most often treated with Capecitabine?
"Capecitabine is a potent medication commonly prescribed to treat malignant neoplasms, neuroectodermal melanoma that can't be removed surgically, microsatellite instability high or when the risk of recurrence is particularly elevated."
How many people are currently participating in the research endeavor?
"Unfortunately, this clinical trial is not actively enrolling patients. It was originally listed on February 23rd 2016 and the last update took place October 26th 2022. However, if you are still interested in participating there are currently 2,351 studies recruiting for triple negative breast neoplasms and 1,968 studies looking for volunteers to take part with Capecitabine trials."
Are there any extant accounts related to Capecitabine efficacy?
"Presently, there are 1968 trials of Capecitabine taking place worldwide with 432 studies in Phase 3. Notably, Guangzhou, Guangdong alone has multiple active sites for the trial and 84040 locations globally have opened their doors to those seeking treatment with this medication."
Is participation in this clinical investigation accessible to people at present?
"This clinical trial is no longer seeking participants for enrollment. The initial posting was made on February 23rd 2016, and the page has been recently edited as of October 26th 2022 should one wish to consult it. Alternatively, if you are searching for other studies involving triple negative breast neoplasms or Capecitabine there are presently 2351 and 1968 trials actively recruiting respectively."
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