Atezolizumab, Cobimetinib, and Eribulin in Treating Patients With Chemotherapy Resistant Metastat… (NCT03202316) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Atezolizumab, Cobimetinib, and Eribulin in Treating Patients With Chemotherapy Resistant Metastatic Inflammatory Breast Cancer
United States37 participantsStarted 2017-08-11
Plain-language summary
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 (metastatic). 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Signed informed consent form (ICF) and comply with the requirements of the study protocol
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Confirmed diagnosis of inflammatory breast cancer according to international consensus criteria: (1) onset: rapid onset of breast erythema, edema, and/or peau d'orange, and/or warm breast, with or without an underlying breast mass (2) duration: history of such findings no more than 6 months (3) extent: erythema occupying at least 1/3 of whole breast (4) pathology: pathologic confirmation of invasive carcinoma
* Patients with recurrent or metastatic IBC after standard systemic therapy are eligible; patients who have disease progression while receiving standard anthracycline or taxane based neoadjuvant therapy are also eligible. a. patients with HER2-positive disease must have had at least 2 lines of anti-HER2 therapy, including Perjeta and Kadcyla; b. prior eribulin treatment is allowed
* At least one metastatic lesion amendable for biopsy (core, punch, or fine needle aspiration \[FNA\]); if the patient only has lymph nodes, these are considered amenable but will not be biopsied
* At least one site of measurable disease (per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1), local or distant
* Any estrogen receptor (ER), progesterone receptor (PR), HER2 status
* Absolute neutrophil count (ANC) \>= 1500 cells/uL (obtained within 14 days prior to the first study treatment \[PD window day 1…