Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer

NCT05041101 | Terminated Phase 1 Results DMC FDA Drug

• 2 other identifiers: 2021-0077NCI-2021-09158
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. Eribulin may block tumor cell growth by stopping tumor cell division. Giving grapiprant and eribulin together may help to control the disease.

Conditions

Breast Inflammatory Carcinoma; Recurrent Breast Inflammatory Carcinoma; Stage IV Breast Inflammatory Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 21 days from the initial treatment

• 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).

  Up to 1 year

Secondary Outcomes (7)

• Determine Objective Response Rate (ORR)

  Up to 1 year

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

  Up to 1 year

• Determine the Duration of Response of the Proposed Treatment in Phase II

  Up to 2 years

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

  Up to 2 years

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

  Up to 1 year

Study Arms (1)

Treatment (grapiprant, eribulin mesylate)

EXPERIMENTAL

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.

Drug: Eribulin Mesylate; Drug: Grapiprant

Interventions

Eribulin Mesylate DRUG

Given IV

Also known as: B1939 Mesylate, E7389, ER-086526, Halaven, Halichondrin B Analog

Treatment (grapiprant, eribulin mesylate)

Grapiprant DRUG

Given PO

Also known as: AAT-007, AT-001, CJ 023,423, CJ-023,423, CJ023,423, RQ-00000007, RQ-07

Treatment (grapiprant, eribulin mesylate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Inflammatory Breast Neoplasms

Interventions

eribulin; grapiprant; caficrestat

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Sadia Saleem, MD
• Organization: The University of Texas MD Anderson Cancer Center

ssaleem@mdanderson.org

(281) 566-1900

Study Officials

• Sadia Saleem

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 10, 2021
• Study Start: December 21, 2021
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2025-05

Locations

US (1)