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Monoclonal Antibodies
Combination Therapy for Inflammatory Breast Cancer
Phase 2
Waitlist Available
Led By Vicente Valero
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with recurrent or metastatic IBC after standard systemic therapy are eligible
Confirmed diagnosis of inflammatory breast cancer according to international consensus criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 years
Awards & highlights
Study Summary
This trial is studying a combination of immunotherapy, targeted therapy, and chemotherapy to see if it is more effective than standard chemotherapy in treating patients with metastatic inflammatory breast cancer.
Who is the study for?
This trial is for patients with inflammatory breast cancer that has spread (metastatic) and didn't respond to standard treatments. Participants must have measurable disease, be able to provide a biopsy, agree to use contraception, and meet certain health criteria like heart function and blood counts. They shouldn't have had major surgery recently or used some other cancer therapies.Check my eligibility
What is being tested?
The study tests combining atezolizumab (an immune system booster), cobimetinib (a cell growth blocker), and eribulin (chemotherapy) in treating metastatic inflammatory breast cancer. It's a phase II trial aiming to see if this combo is more effective than current treatments.See study design
What are the potential side effects?
Possible side effects include reactions from the immune system such as inflammation in organs, infusion-related reactions, fatigue; liver issues due to cobimetinib; plus typical chemotherapy side effects like hair loss, nausea, low blood cell counts leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer has returned or spread after standard treatment.
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My breast cancer is officially diagnosed as inflammatory.
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I am fully active or can carry out light work.
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I have a cancer spread that can be biopsied.
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My cancer's hormone receptor status is known.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Clinical benefit rate (CBR)
Duration of response (DOR)
Incidence of adverse events
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Cohort II (atezolizumab, eribulin)Experimental Treatment4 Interventions
Patients receive atezolizumab IV over about 30-60 minutes every 3 weeks for cycles 1-6 and every 4 weeks for subsequent cycles, and eribulin IV over 2-5 minutes on days 1 and 8 of cycles 1-6. Cycles 1-6 repeat every 21 days and subsequent cycles with atezolizumab repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Cohort I (atezolizumab, cobimetinib, eribulin)Experimental Treatment5 Interventions
Patients receive atezolizumab IV over about 30-60 minutes every 2 weeks, cobimetinib PO daily for 3 weeks on, 1 week off for 4 weeks of the safety lead-in course. Patients then receive atezolizumab IV over about 30-60 minutes every 2 weeks, cobimetinib PO daily for 3 weeks on, 1 week off, and eribulin IV over 2-5 minutes on days 1 and 8 of cycles 1-4. Cycles 1-4 repeat every 21 days and subsequent cycles with atezolizumab and cobimetinib repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cobimetinib
FDA approved
Eribulin
FDA approved
Atezolizumab
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,181 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
Vicente ValeroPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
802 Total Patients Enrolled
1 Trials studying Breast Cancer
20 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood needs to have certain levels of different types of cells and chemicals.I have a history of lung problems.I have not had any recent infections requiring antibiotics.I am not excluded from taking Cobimetinib.My breast cancer has returned or spread after standard treatment.My breast cancer is officially diagnosed as inflammatory.I am currently using or have used specific cancer treatments.I still have side effects from previous cancer treatments.You are known to have severe allergic reactions to specific products.My health condition has not worsened in the past year.I have not had any other cancers in the last 5 years.Your heart is pumping blood normally, as shown by a special heart scan or ultrasound.I do not have significant liver disease and am not pregnant or breastfeeding.I have an autoimmune disease or immune deficiency.I have not received a live flu vaccine recently.I have not had major surgery in the last 28 days.You have at least one area of the body where the disease can be measured.I have not had severe allergic reactions to medications.I am fully active or can carry out light work.Your blood clotting tests should be within the normal range if you are not taking medication to prevent blood clots.I have not been excluded from taking Atezolizumab.I have had an organ transplant and am on anti-rejection medication.I have a cancer spread that can be biopsied.My cancer's hormone receptor status is known.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort I (atezolizumab, cobimetinib, eribulin)
- Group 2: Cohort II (atezolizumab, eribulin)
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Does the FDA endorse using laboratory biomarkers to guide treatment decisions?
"While there is some data supporting safety, as this is a phase 2 trial, there is no evidence yet of efficacy. Therefore, our team has given Laboratory Biomarker Analysis a score of 2."
Answered by AI
What disorders does Laboratory Biomarker Analysis commonly target?
"small cell lung cancer (sclc), metastatic melanoma, and breast cancer can all be treated by studying and manipulating the patient's laboratory biomarkers."
Answered by AI
Are there other examples where Laboratory Biomarker Analysis has been used in research?
"421 live trials are currently underway to test the efficacy of laboratory biomarkers. 84 of these trials have progressed to phase 3 testing. The majority of these tests are taking place in Tampa, Florida, but 20567 other locations are also running similar trials."
Answered by AI
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