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Vaccine + Chemotherapy + Immunotherapy for Breast Cancer
Study Summary
This trial is testing how well a combination of chemotherapy drugs, immunotherapy drugs, and a personalized vaccine work in treating patients with metastatic triple negative 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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- Your hemoglobin level is at least 9.0 grams per deciliter.I do not have brain metastases or any known central nervous system disease.I haven't taken immunosuppressive drugs in the last 14 days.Your bilirubin levels in the blood should not be higher than 1.5 times the upper limit of normal.I haven't had a live vaccine in the 6 months before joining the study or within 30 days of starting treatment.Your heart's electrical activity, measured by a test called an ECG, shows a prolonged QT interval.I do not have any serious ongoing illnesses that my doctor is still trying to control.I can provide a biopsy sample from my advanced or relapsed cancer.I have triple-negative breast cancer and haven't been treated for its advanced stage. I had taxane therapy but have been disease-free for over a year.You have enough white blood cells called neutrophils.Your liver enzymes must not be too high, unless you have cancer that has spread to your liver.I agree to use birth control or abstain from sex during and up to 180 days after the study.I am willing and able to follow the study's treatment and visit schedule.I am HIV-positive with a controlled viral load, CD4 count over 250, and on stable medication.I can understand and am willing to sign the consent form, or I have someone who can do it for me.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I am considered a candidate for carboplatin + gemcitabine for my metastatic triple negative breast cancer.I have recovered from serious side effects of cancer treatment, except for hair loss or skin changes.I haven't had chemotherapy, radiotherapy to a large part of my bone marrow, or biologic therapy in the last 30 days.My breast cancer is not driven by estrogen or progesterone.I am not pregnant or breastfeeding, and I have a recent negative pregnancy test.I have been cancer-free for at least a year, except for certain skin cancers or early cervical cancer.I have been diagnosed with metastatic triple negative breast cancer.My cancer is HER2 negative based on specific tests.My cancer can be measured or seen on tests.I am 18 years old or older.I do not have an active infection like TB, hepatitis B, or hepatitis C.I had cancer before, but I meet the survivor criteria for this study.My cancer is PD-L1 negative according to an FDA-approved test.My kidney function, measured by creatinine clearance, is adequate.I have received an organ transplant from another person.I have moderate to severe nerve pain or damage.You have had serious allergic reactions to drugs similar to durvalumab and tremelimumab, or to vaccines in the past.I haven't had major surgery in the last 28 days, except for minor surgeries for symptom relief.You weigh more than 30 kilograms.I have completed treatment aimed at curing any previous cancers.I am post-menopausal or not currently pregnant.I have had pneumonitis or lung disease affecting the tissue and space around the air sacs.I have received immunotherapy for my cancer after it spread.Your platelet count is at least 100,000 per microliter.I am mostly self-sufficient and can carry out daily activities.
- Group 1: Arm II (durvalumab, nab-paclitaxel)
- Group 2: Arm I (neoantigen vaccine, durvalumab, nab-paclitaxel)
- 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
Are there any vacancies for participants in this exploration?
"Affirmative. According to information on clinicaltrials.gov, this medical study first posted in December 14th 2018 is currently accepting participants. 70 total patients are needed at 14 distinct sites."
What is the upper bound of participants involved in this research?
"Affirmative. Clinicaltrials.gov's information confirms that this medical trial is presently recruiting, having been initially posted on December 14th 2018 and last edited on November 30th 2022. 70 participants are needed from a total of 14 different clinical sites."
Does the Personalized Synthetic Long Peptide Vaccine pose any danger to users?
"The Personalized Synthetic Long Peptide Vaccine has a safety rating of 2 due to the Phase 2 trial results, which contain limited evidence that it is safe but no data proving its efficacy."
What illnesses can be targeted with Personalized Synthetic Long Peptide Vaccine?
"Personalized Synthetic Long Peptide Vaccine can be utilized to protect against central volume depletion, prior anthracycline-based adjuvant therapy and hypoalbuminemia."
How many healthcare facilities in the US are currently conducting this research?
"This clinical trial is recruiting patients from several medical centres, including Yale University in New Haven, Connecticut; UC Irvine Health/Chao Family Comprehensive Cancer Center in Orange, California; and the Siteman Cancer Center at Saint Peters Hospital in Saint Peters Colorado. Additionally, 14 other sites are participating as well."
Has the efficacy of Personalized Synthetic Long Peptide Vaccine been tested in prior research endeavors?
"Since its inception in 1997, the Personalized Synthetic Long Peptide Vaccine has been studied extensively: 2469 clinical trials have been completed and 1708 are still active. Many of these studies take place at City of Hope Comprehensive Cancer Center in New Haven, Connecticut."
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