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Anti-tumor antibiotic
Grapiprant + Eribulin for Metastatic Breast Cancer
Phase 1 & 2
Waitlist Available
Led By Naoto T Ueno
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
Has a distant metastasis site or locoregional recurrence
Has histological confirmation of breast carcinoma with a clinical diagnosis of IBC based on the presence of inflammatory changes in the involved breast, including diffuse erythema and edema (peau d'orange), with or without an underlying palpable mass involving the majority of the skin of the breast. Or the diagnosis confirmed by the MD Anderson IBC specialists. Pathological evidence of dermal lymphatic invasion should be noted but is not required for the diagnosis of IBC
Must not have
Has a diagnosis of immunodeficiency, or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy
Is currently participating in a study of an investigational anti-cancer agent or receiving concurrent anti-cancer therapy for metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights
Summary
This trial tests if the combination of grapiprant and eribulin can safely shrink tumors in patients with advanced inflammatory breast cancer. Grapiprant reduces inflammation to prevent tumor growth, while eribulin stops cancer cells from dividing. The goal is to see if this combination can control the disease.
Who is the study for?
Adults with inflammatory breast cancer that has spread (metastatic) and have had certain prior treatments can join. They must be in good enough health, not pregnant or breastfeeding, willing to use birth control, and able to provide consent. People with uncontrolled high blood pressure, serious heart conditions, active hepatitis B or C, severe neuropathy, immunodeficiency on treatment, brain metastases using steroids recently cannot participate.
What is being tested?
The trial is testing the combination of grapiprant (an anti-inflammatory drug) and eribulin mesylate (a drug that may stop tumor cells from dividing) for their effectiveness in shrinking tumors in patients with advanced inflammatory breast cancer.
What are the potential side effects?
Possible side effects include typical reactions related to anti-inflammatory drugs like stomach issues and bleeding risks. Eribulin might cause fatigue, low blood cell counts leading to increased infection risk or bleeding problems, hair loss, nerve damage causing numbness or tingling.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread to distant parts of my body or has come back in the same area.
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I have been diagnosed with inflammatory breast cancer.
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I can take care of myself and am up and about more than half of my waking hours.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an immune system disorder or am on long-term steroids or other drugs that weaken my immune system.
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I am not currently in a trial for or taking any experimental cancer treatments.
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I am currently on medication for an infection.
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I have a history of heart disease or currently have heart problems.
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My blood pressure is not higher than 150/90 mmHg.
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I have severe nerve pain or damage.
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I am taking strong medication that affects how drugs are processed in my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical benefit rate (CBR)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (grapiprant, eribulin mesylate)Experimental Treatment2 Interventions
Patients receive grapiprant PO BID on day 1-21 and eribulin mesylate IV over 5 minutes on days 1 and 8. Cycles 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
Eribulin Mesylate
2014
Completed Phase 4
~3420
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for breast cancer include anti-inflammatory agents and microtubule inhibitors. Anti-inflammatory agents, like Grapiprant, work by reducing inflammation that can promote tumor growth, thereby potentially preventing the progression of cancer.
Microtubule inhibitors, such as Eribulin, disrupt the microtubule dynamics necessary for cell division, leading to the inhibition of tumor cell proliferation. These mechanisms are crucial for breast cancer patients as they target the cancer cells' ability to grow and spread, offering a strategic approach to manage and potentially reduce the tumor burden.
Tumor-Preferential Induction of Immune Responses and Epidermal Cell Death in Actinic Keratoses by Ingenol Mebutate.
Tumor-Preferential Induction of Immune Responses and Epidermal Cell Death in Actinic Keratoses by Ingenol Mebutate.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,676 Total Patients Enrolled
148 Trials studying Breast Cancer
63,277 Patients Enrolled for Breast Cancer
Naoto T UenoPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
2,500 Total Patients Enrolled
Sadia SaleemPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your liver enzymes (ALT and AST) are not too high, unless you have cancer that has spread to your liver.I am willing to undergo a biopsy if my tumor can be safely accessed.I am not pregnant or breastfeeding and use approved birth control or am sterile/post-menopausal. For males, I use birth control or am sterile.My cancer has spread to distant parts of my body or has come back in the same area.I have an immune system disorder or am on long-term steroids or other drugs that weaken my immune system.Your total bilirubin level is not higher than 1.5 times the upper limit of normal, unless you have liver metastasis, in which case it should not be higher than 3 times the upper limit of normal.I am not currently in a trial for or taking any experimental cancer treatments.I am currently on medication for an infection.Your kidney function, measured by the Cockcroft-Gault GFR, needs to be at least 50 mL/min/1.73 m^2 or higher.I have undergone hormone therapy in the past 3 years.I haven't had treatment for a life-threatening cancer other than my current one in the last 3 years.I am 18 years old or older.My cancer is HER2+ and treatments with trastuzumab, pertuzumab, and T-DM1 have not worked.Your heart's pumping capacity is at least 50% as shown in an echocardiogram or MUGA scan.I have stopped taking NSAIDs or COX-2 inhibitors at least 2 weeks ago.I have been diagnosed with inflammatory breast cancer.I have not been treated with eribulin or any EP2/4 inhibitor.Your disease can be measured using specific guidelines for determining its size.You have HIV, but your CD4+ T-cell counts are above 350 cells/uL and you have not had certain infections related to AIDS.I have stable brain metastases and haven't used steroids for at least 28 days.I have a history of heart disease or currently have heart problems.My blood pressure is not higher than 150/90 mmHg.You currently have active hepatitis B or C.I have severe nerve pain or damage.I haven't received any cancer treatment in the last 2 weeks.I am taking strong medication that affects how drugs are processed in my body.I can take care of myself and am up and about more than half of my waking hours.You are allergic to halichondrin B or any related chemicals.Your hemoglobin level is at least 9 grams per deciliter.Your absolute neutrophil count is at least 1,200 per microliter.Your platelet count is at least 100,000 per microliter.
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