This phase II trial studies how well atezolizumab, cobimetinib, and eribulin work in treating
patients with inflammatory breast cancer that has spread to other places in the body.
Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune
system attack the cancer, and may interfere with the ability of tumor cells to grow and
spread. Cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed
for cell growth. Drugs used in chemotherapy, such as eribulin, work in different ways to stop
the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by
stopping them from spreading. Giving atezolizumab, cobimetinib, and eribulin may work better
in treating patients with inflammatory breast cancer.
I. To determine ORR (overall response rate) of metastatic inflammatory breast cancer (mIBC)
patients treated with this proposed combinatorial atezolizumab, cobimetinib, and eribulin
(ACE) therapy via phase II.
I. To further characterize the safety and tolerability of, triple combination: ACE therapy.
II. To determine CBR (clinical benefit rate): (stable disease [SD] + complete response [CR] +
partial response [PR]) >= 24 weeks of mIBC patients treated with this proposed combinatorial
therapy via phase II.
III. To determine the duration of response (DOR). IV. To determine progression free survival
(PFS). V. To determine 2 years overall survival (OS).
I. To determine the progressive disease (PD) biomarker changes induced by combinatorial
therapy using liquid and tissue based assays to investigate microenvironment via multiplex
imaging, proportional study of T cells: CD3, CD8 composition and change, macrophage (M1 and
M2), PD-L1 expression on circulating tumor cell (CTC).
II. To determine the immune pathway related biomarker changes induced by combinatorial
therapy via multiplex serum cytokine assays.
III. This translational biomarker assays will be done based on collaboration with plasma
based ribonucleic acid (RNA) sequencing (RNA-seq) in collaboration with Lambowitz laboratory
(lab), Oncomine next-generation sequencing (NGS) study on tumor/circulating tumor
deoxyribonucleic acid (ctDNA) with Wistuba lab, and bioinformatics with Futreal lab.
Patients receive atezolizumab intravenously (IV) over about 30 minutes-1 hour every 2 weeks,
cobimetinib orally (PO) daily for 3 weeks on, 1 week off for 4 weeks of the safety lead-in
course. Patients then receive atezolizumab IV over about 30 minutes-1 hour every 2 weeks,
cobimetinib PO daily for 3 weeks on, 1 week off, and eribulin IV over about 5 minutes on days
1 and 8 of courses 1-4. Courses 1-4 repeat every 21 days and subsequent courses with
atezolizumab and cobimetinib repeat every 28 days in the absence of disease progression or
After completion of the study treatment, patients are followed for 3 months and then every 6
months for at least 2 years.
Congenital Skin Diseases,
Recurrent Inflammatory Breast Carcinoma,
Stage IV Inflammatory Breast 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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