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Monoclonal Antibodies
Carboplatin + Atezolizumab for Stage IV Triple Negative Breast Cancer
Phase 2
Waitlist Available
Research Sponsored by Vanderbilt-Ingram Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ER and PR negativity defined as =< 5% of cells expressing hormonal receptors via IHC analysis
Willing to undergo biopsy of a metastatic lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing whether carboplatin works better with or without atezolizumab to treat patients with stage IV triple negative breast cancer.
Who is the study for?
This trial is for adults with stage IV triple negative breast cancer who have had zero or one prior chemo treatments and no previous carboplatin. They must have a certain level of blood cells, liver function, and kidney clearance. Participants need to be relatively healthy (ECOG 0-1), not pregnant, willing to use contraception if necessary, able to provide consent, and agree to a biopsy.Check my eligibility
What is being tested?
The study compares the effectiveness of chemotherapy drug Carboplatin alone versus combined with Atezolizumab (a monoclonal antibody) in treating advanced breast cancer. It's randomized: patients are put into groups by chance. The goal is to see if adding Atezolizumab improves outcomes.See study design
What are the potential side effects?
Carboplatin can cause nausea, fatigue, low blood counts leading to infection risk or bleeding problems. Atezolizumab may lead to immune-related side effects like inflammation in various organs, infusion reactions similar to allergic responses, and potential worsening of pre-existing autoimmune diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is not driven by estrogen or progesterone.
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I am willing to have a biopsy of my cancer that has spread.
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My alkaline phosphatase levels are within the limit, considering my liver metastases.
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My cancer is not driven by estrogen or progesterone.
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My white blood cell count is healthy without needing medication in the last 2 weeks.
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I am fully active or can carry out light work.
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My breast cancer is stage IV and lacks ER, PR, and HER2 receptors.
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I have had at most one chemotherapy treatment for my advanced cancer.
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I am considered postmenopausal based on my age and hormone levels.
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I have never been treated with carboplatin.
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My cancer is not HER2 positive according to the latest tests.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Clinical Benefit Rate (CBR)
Duration of Response (DOR)
Overall Response Rate (ORR)
+1 moreOther outcome measures
Assignment of a Triple Negative Subtype in Tumor Tissue as Assessed by Ribonucleic Acid-sequencing (RNA-seq)
Changes in Gene Expression in Tumor Tissue as Assessed by Ribonucleic Acid-sequencing (RNA-seq)
Define Mutations Present in the Tumors as Assessed by Ribonucleic Acid-sequencing (RNA-seq)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2 (atezolizumab, carboplatin)Experimental Treatment4 Interventions
Patients receive carboplatin as in Arm 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may cross-over to Arm 1 upon disease progression.
Group II: Arm 1 (atezolizumab, carboplatin)Experimental Treatment4 Interventions
Patients receive atezolizumab IV over 30-60 minutes and carboplatin IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Carboplatin
FDA approved
Find a Location
Who is running the clinical trial?
Vanderbilt-Ingram Cancer CenterLead Sponsor
213 Previous Clinical Trials
60,827 Total Patients Enrolled
28 Trials studying Breast Cancer
6,594 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,047 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,583 Total Patients Enrolled
97 Trials studying Breast Cancer
23,218 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My hemoglobin level is at least 9.0 g/dL, with or without treatment.My bilirubin levels are within the limit, considering I have liver metastases.My cancer is not driven by estrogen or progesterone.I am willing to have a biopsy of my cancer that has spread.My alkaline phosphatase levels are within the limit, considering my liver metastases.I have a serious heart condition.My cancer is not driven by estrogen or progesterone.I have not had a severe infection needing treatment in the last 4 weeks.I have active tuberculosis.I have not received a live vaccine in the last 4 weeks.I have previously been treated with specific immune-targeting cancer drugs.My white blood cell count is healthy without needing medication in the last 2 weeks.I am fully active or can carry out light work.My breast cancer is stage IV and lacks ER, PR, and HER2 receptors.My liver function tests are within the required range.I have untreated or worsening spinal cord compression due to cancer.My brain or spinal cord cancer does not meet certain criteria.I have not had major surgery in the last 4 weeks.I am allergic to certain medications made in Chinese hamster ovary cells or any part of atezolizumab.I haven't taken any immune-boosting drugs in the last 4 weeks or five half-lives of the drug.My cancer is HER2 negative based on specific test results.I am willing to have a biopsy of my cancer that has spread if it's in an accessible place.I have had at most one chemotherapy treatment for my advanced cancer.My cancer has spread to the lining of my brain and spinal cord.I have active hepatitis B or C.You must give written permission after fully understanding the details of the study.My cancer causes me severe pain that isn't managed well.You have experienced severe reactions to certain types of medication called chimeric or humanized antibodies or fusion proteins in the past.I do not have any uncontrolled serious illnesses.I have high calcium levels in my blood that are causing symptoms.I am considered postmenopausal based on my age and hormone levels.I have never been treated with carboplatin.You are undergoing cancer treatment that is not allowed in this study.My cancer is not HER2 positive according to the latest tests.I have a history of lung scarring or currently have lung inflammation.I haven't taken steroids or immunosuppressants in the last 2 weeks.You have a history of autoimmune disease.I have not had any cancer other than triple-negative breast cancer in the last 5 years.You have enough lymphocytes (a type of white blood cell) in your blood.I am fully active or can carry out light work.You have a visible or measurable tumor that can be accurately measured using a specific method called RECIST criteria version 1.1.You have received an organ or stem cell transplant in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2 (atezolizumab, carboplatin)
- Group 2: Arm 1 (atezolizumab, carboplatin)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the usual purpose for running a Laboratory Biomarker?
"The laboratory biomarker is most frequently used to treat advanced thymoma, but it can also be effective for small cell lung cancer (sclc), advanced testicular cancer, and carcinoma, neuroendocrine."
Answered by AI
Are there any other ongoing experiments that use Laboratory Biomarker?
"Laboratory Biomarker was first researched in 2002 at H Central de Asturias. Since that time, there have been 1015 completed trials and 1027 active clinical trials. Many of these are based out of Philadelphia, Pennsylvania."
Answered by AI
How many patients are in this clinical trial?
"Unfortunately, this study is no longer looking for new participants. The trial was first posted on 8/29/2017 and ended on 8/31/2022. However, there are currently 2445 other studies searching for patients with triple negative breast neoplasms and 1027 Laboratory Biomarker studies that are still enrolling individuals."
Answered by AI
Are investigators still looking for new participants for this trial?
"Unfortunately, this particular clinical trial is not presently enrolling patients. The listing on clinicaltrials.gov reflects that this study was posted on 8/29/2017 and was last edited on 8/31/2022; however, there are other trials recruiting participants right now--3,472 to be exact."
Answered by AI
In how many different medical clinics is this trial currently taking place?
"University of Pennsylvania in Philadelphia, Indiana University Health Melvin Bren Simon Cancer Center in Indianapolis, Georgetown University Lombardi Comprehensive Cancer Center in Washington D.C., and 6 other locations are currently recruiting patients for this trial."
Answered by AI
Is Laboratory Biomarker accepted by the FDA?
"There is some supporting data for the safety of this laboratory biomarker, but none yet for efficacy. Consequently, our team has tentatively rated it as a 2."
Answered by AI
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