What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as anti-inflammatory drugs like Grapiprant and chemotherapy agents like Eribulin, have several known side effects. Grapiprant may cause gastrointestinal issues, while Eribulin is associated with increased toxicity, including neutropenia (low white blood cell count), pyrexia (fever), peripheral sensory neuropathy (nerve damage causing pain or numbness), and alopecia (hair loss). These side effects are typical of many chemotherapy regimens used in breast cancer treatment.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of breast cancer that are similar to Grapiprant and Eribulin. Eribulin mesylate, specifically, is an FDA-approved drug that inhibits tumor cell division by targeting microtubules, which is similar to its use in the trial mentioned. Other drugs that inhibit tumor cell division include paclitaxel and docetaxel, which are taxanes used in various breast cancer treatment regimens. While there are fewer direct anti-inflammatory drugs approved specifically for breast cancer, some treatments like corticosteroids are used adjunctively to manage inflammation and symptoms associated with cancer and its treatment.

What other types of research exist?

Promising novel alternatives for breast cancer treatment in 2024 include: 1) Trastuzumab deruxtecan, a HER2-targeted antibody-drug conjugate showing efficacy in HER2-positive metastatic breast cancer. 2) Pembrolizumab, an immune checkpoint inhibitor, used in combination with chemotherapy for triple-negative breast cancer. 3) PARP inhibitors like Olaparib for BRCA-mutated breast cancer. These therapies offer targeted mechanisms to inhibit tumor growth and cell division.

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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

No Placebo-Only Group

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met

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.