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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat inflammatory breast cancer that has spread to other parts of the body. The drugs, grapiprant and eribulin, may help to shrink tumors and 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.Check my eligibility
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.See study design
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.
Select...
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical benefit rate (CBR)
Incidence of dose-limiting toxicity
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
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,777 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a history of research involving Eribulin Mesylate?
"At the moment, research into Eribulin Mesylate is being conducted via 38 clinical trials. Of those ongoing studies, 11 have reached Phase 3. Interestingly, there are 1305 different sites conducting these tests; however, most of them are located in Seoul and Florida."
Answered by AI
Does this medical experiment currently have openings for participants?
"Affirmative. Documents hosted on clinicaltrials.gov display that this medical study, first published on November 4th 2021, is actively seeking participants. The trial is expecting to enroll 25 patients from a single centre."
Answered by AI
How many participants are engaging in this clinical experiment?
"Affirmative. The details hosted on clinicaltrials.gov denote that this medical trial is presently seeking applicants; the study was first made available to the public on November 4th 2021 and has more recently been updated on June 27th 2022. Specifically, 25 patients need to be enrolled from one site."
Answered by AI
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