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.
I. To determine the safety and efficacy of grapiprant and eribulin combination treatment for
the patient with metastatic inflammatory breast cancer (mIBC).
I. 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.
I. To evaluate the changes in the tumor microenvironment after the proposed treatment.
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.
Breast Inflammatory Carcinoma, Recurrent Breast Inflammatory Carcinoma, Stage IV Breast Inflammatory Carcinoma
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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