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Breast Inflammatory CarcinomaPhase 1/2NCT05041101

Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer

A Phase 1/2 study testing Eribulin Mesylate and Grapiprant in people with Breast Inflammatory Carcinoma and Recurrent Breast Inflammatory Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase Ib/II trial tests the safety and side effects of grapiprant and eribulin and whether they work to shrink tumors in patients with inflammatory breast cancer that has spread to other places in the body (metastatic). Grapiprant is an anti-inflammatory drug that may prevent tumor growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Eribulin Mesylate and Grapiprant
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
21 Dec 2021to 6 Sep 2024
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female >= 18 years of age
  • Is willing and able to provide written informed consent for the trial
  • 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
  • Any prior treatments will be allowed except eribulin and/or any EP2/4 inhibitor
  • Has at least 2 weeks of untreated period from the previous treatment
  • Any receptor status for ER/PR and HER2. But for HER2+ type, must has failed trastuzumab, pertuzumab, and T-DM1 treatment.
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  • NOTE: HER2 positive status is defined as strongly positive (3+) staining score by immunohistochemistry (IHC), or gene amplification using fluorescence in situ hybridization (FISH), if performed. If IHC is equivocal (2+). HER2 negative status, which is determined by assays using IHC require negative (0 or 1+) staining score. If IHC is equivocal (2+) staining score
  • Has a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 (only applies to phase II part)
  • NOTE: Measurable disease: Measurable lesions are defined as those that can be accurately measured in at least one-dimension (longest diameter to be recorded) as >= 20 mm by chest X-ray, >= 10 mm by computed tomography (CT) scan, >= 10 mm with calipers by clinical exam. Measurable malignant lymph nodes: To be considered pathologically enlarged and measurable, a lymph node must be >= 15mm in short axis when assessed by CT scan. Non-measurable disease: All other lesions (or sites of disease), including small lesions, are considered non-measurable. Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, lymphangitis, cutis/pulmonitis, inflammatory breast disease, and abdominal masses (not followed by CT or magnetic resonance imaging [MRI]) are considered non-measurable
  • Has a distant metastasis site or locoregional recurrence
  • Is willing to provide fresh tumor tissue via tumor biopsy before the first dose of the study drug only if participant has a disease can be be safely accessed through a CT-guided/ultrasound (US)-guided or percutaneous biopsy for multiple core biopsies judged by the investigator. If participant doesn't have a disease that can be safely accessed, they are still eligible
  • Performance status (PS) of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) performance scale
  • Absolute neutrophil count (ANC) >= 1,200 /mcL
  • Platelets >= 100,000 /mcL
  • Hemoglobin (Hgb) >= 9 g/dL
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) (up to =< 3 x ULN for patients with liver metastasis)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (up to =< 5 x ULN for patients with liver metastasis)
  • Cockcroft-Gault glomerular filtration rate (GFR) (mL/min/1.73 m^2) >= 50
  • Left ventricular ejection fraction (LVEF) >= 50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
  • Female patients must not be pregnant or breastfeeding and must be practicing a medically acceptable form of locally approved birth control, be sterile or post-menopausal. Male patients should be using a medically acceptable form of birth control during the trial or be sterile
  • Female patient: A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) OR
  • A WOCBP agrees to follow the contraceptive guidance during the treatment period and at least 6 months after the last dose of trial intervention and must refrain from breastfeeding for at least 2 months after the last grapiprant treatment
  • WOCPB must have a negative urine pregnancy test no more than 7 days prior to starting treatment on-study
  • Male patients: A male patient must agree to use contraception during the treatment period and for at least 6 months after the last grapiuprant treatment and refrain from donating sperm during this period
  • Patient with human immunodeficiency virus (HIV) including current or prior infection would be included if:
  • With CD4+ T-cell (CD4+) counts >= 350 cells/uL
  • Without a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections

Who cannot join

  • Current chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors. We will allow prior use of those agents if patients stop them at least 2 weeks before accrual
  • Is currently participating in a study of an investigational anti-cancer agent or receiving concurrent anti-cancer therapy for metastatic disease
  • Has a diagnosis of immunodeficiency, or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy
  • Uncontrolled hypertension is defined as a systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg, with or without antihypertensive medications
  • Has a history of and/or active cardiac diseases
  • History of cardiac diseases including:
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  • Active myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular function
  • History of documented chronic heart failure; and documented cardiomyopathy
  • Active cardiac diseases including:
  • Symptomatic angina pectoris within the past 180 days that required the initiation of or increase in anti-anginal medication or other intervention
  • Ventricular arrhythmias except for benign premature ventricular contractions
  • Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication
  • Conduction abnormality requiring a pacemaker
  • Valvular disease with documented compromise in cardiac function
  • Symptomatic pericarditis
  • Has preexisting neuropathy > grade 2
  • Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative
  • Has medical conditions requiring concomitant administration of strong CYP3A4 or P-glycoprotein inhibitors or inducers
  • Potentially life-threatening second malignancy requiring systemic treatment within the last 3 years (i.e., patients with a history of prior malignancy are eligible if treatment was completed at least 3 years before entering the Treatment period and the patient has no evidence of disease) or which would impede evaluation of treatment response.
  • Hormone ablation therapy is allowed within the last 3 years.
  • Patients with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate if they are stable and have no evidence of new or enlarging brain metastases. They are not using steroids for at least 28 days before trial treatment
  • Active infection requiring systemic therapy
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Known active hepatitis B or C

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase Ib/II Study of Grapiprant (IK-007) and Eribulin Combination Treatment for Metastatic Inflammatory Breast Cancer (mIBC)

This phase Ib/II trial tests the safety and side effects of grapiprant and eribulin and whether they work to shrink tumors in patients with inflammatory breast cancer that has spread to other places in the body (metastatic). Grapiprant is an anti-inflammatory drug that may prevent tumor growth. Eribulin may block tumor cell growth by stopping tumor cell division. Giving grapiprant and eribulin together may help to control the disease.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the safety and efficacy of grapiprant and eribulin combination treatment for the patient with metastatic inflammatory breast cancer (mIBC).

SECONDARY OBJECTIVES:

  1. To determine objective response rate (ORR), % of the patients who achieve complete response (CR) or partial response (PR).

II. To determine the time to progression (TTP) of the proposed treatment. III. To determine the duration of response of the proposed treatment. (Phase 2 only) IV. To determine the time to first response of the proposed treatment. (Phase 2 only) V. To determine progression-free survival (PFS) of the proposed treatment. VI. To determine the overall survival (OS) of the proposed treatment. VII. To investigate the predictive biomarker of the proposed treatment.

EXPLORATORY OBJECTIVE:

  1. To evaluate the changes in the tumor microenvironment after the proposed treatment.

OUTLINE:

Patients receive grapiprant orally (PO) twice daily (BID) on day 1-21 and eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, then yearly for up to 5 years.

Being tested
Eribulin Mesylate, Grapiprant
Medical subject headings
Inflammatory Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eribulin MesylateDrug

    Also called B1939 Mesylate, E7389, ER-086526, Halaven

    Given IV

  • GrapiprantDrug

    Also called AAT-007, AT-001, CJ 023,423, CJ-023,423

    Given PO

Study groups in NCT05041101
Study groupRoleWhat they receive
Treatment (grapiprant, eribulin mesylate)ExperimentalPatients 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.
Receives: Drug: Eribulin Mesylate; Drug: Grapiprant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the Safety of Grapiprant and Eribulin Combination Treatment

    Dose-limiting toxicity was defined as probable, possible, and definite events that occurred in the first 21 days (Cycle 1), as prespecified in the protocol.

    Measured: Up to 21 days from the initial treatment

  2. Determine the Efficacy of Grapiprant and Eribulin Combination Treatment

    Clinical Benefit Rate (CBR) was defined as the ratio of patients who achieved a complete response (CR), partial response (PR), or stable disease (SD) (lasting >24 weeks).

    Measured: Up to 1 year

Secondary outcomes (7)

  1. Determine Objective Response Rate (ORR)

    The percentage of the patients who achieved complete response (CR) or partial response (PR).

    Measured: Up to 1 year

  2. Determine the Time to Progression (TTP) of the Proposed Treatment.

    Time to progression (TTP), defined as the time from the start of grapiprant treatment to objective tumor progression (PD), was analyzed using the Kaplan-Meier method, and the median with 95% confidence intervals was reported.

    Measured: Up to 1 year

  3. Determine the Duration of Response of the Proposed Treatment in Phase II

    The time from observing the response to the grapiprant treatment until objective tumor progression (PD)

    Measured: Up to 2 years

  4. Determine the Time to First Response of the Proposed Treatment in Phase II

    The time from starting grapiprant treatment until observing the response.

    Measured: Up to 2 years

  5. Determine Progression-free Survival (PFS) of the Proposed Treatment

    Progression-free survival (PFS) was defined as the time from starting grapiprant treatment until objective tumor progression (PD) or death from any cause and was summarized using the Kaplan-Meier method, including the median with 95% confidence intervals.

    Measured: Up to 1 year

  6. Determine the Overall Survival (OS) of the Proposed Treatment

    Overall survival (OS) was defined as the time from starting grapiprant treatment until death from any cause and was summarized using the Kaplan-Meier method, including the median with 95% confidence intervals.

    Measured: Up to 1.5 year

  7. Investigate the Predictive Biomarker for the Proposed Treatment

    Determine the association between treatment response and the change in prostaglandin E2 metabolite (PGEM) levels in urine samples collected pre- and post-treatment.

    Measured: Baseline and Cycle 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2021
  2. Study start21 Dec 2021
  3. Primary completion6 Sep 2024
  4. Study completion6 Sep 2024

Why it stopped: Termination was requested by study supporter IKENA oncology

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05041101
Sponsor's protocol ID
2021-0077
Other IDs
NCI-2021-09158, 2021-0077
Status last verified
May 2025
First submitted
2 Sep 2021
Last updated
13 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Eribulin Mesylate and Grapiprant in people with Breast Inflammatory Carcinoma and Recurrent Breast Inflammatory Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the Safety of Grapiprant and Eribulin Combination Treatment (time frame: Up to 21 days from the initial treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05041101.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.

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