Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER-family and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test

Inclusion criteria

• ✓. Signed Informed Consent Form (ICF) and comply with the requirements of the study protocol
• ✓. Age ≥ 18 years.
• ✓. ECOG performance status 0-1
• ✓. Confirmed diagnosis of metastatic breast cancer or inflammatory breast cancer according to international consensus criteria:
• ✓. Patients who have metastatic disease which is not amenable to curative treatment with available local and systemic therapy. Patients must have received at least 1 line or up to 6 lines of therapy in the metastatic setting with at least 2 weeks washout period before the initiation of study treatment.
• ✓. For Phase Ib, any ER, PR, and HER2 status, For Phase 2, HER2-negative per ASCO/CAP guidelines and any ER and PR status.
• ✓. For Phase II only, Patients with measurable disease according to the Response Evaluation Criteria in Solid Tumor (RECIST, v1.1) (local or distant) and at least one metastatic lesion amenable for biopsy (core or punch)
• ✓. Left Ventricular Ejection Fraction ≥ 50% measured by MUGA scan or Echocardiogram.

Exclusion criteria