NCT05372614: Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene

NCT05372614
Breast Cancer Type: HER2+
Hormone Mutations: ER+, PR+
Other Mutations: HER2
Breast Cancer Tissue: 
Recruitment Status: Recruiting
Phase 1
Drug Category: Therapeutic Antibody, Tyrosine Kinase Inhibitor

Key Eligibility Criteria:

Gender: All
Age: 18 Years and older (Adult, Older Adult)
Location of Metastases: 
Additional Notes: See trial for list of eligible HER2 activating mutations
Exclusions: Patients who have received Nerlynx/neratinib or Enhertu/DS-8201a previously; Patients with symptomatic, unstable, untreated brain or leptomeningeal metastases- see trial for details
https://ClinicalTrials.gov/show/NCT05372614

NCT05243641: Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER2 and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test

NCT05243641
Breast Cancer Type: HER2+, HR+ & HER2-negative, Triple Negative
Hormone Mutations: ER+, PR+
Other Mutations: MET, HER2
Breast Cancer Tissue: Inflammatory breast cancer (IBC)
Recruitment Status: Not yet recruiting
Phase 1|Phase 2
Drug Category: Tyrosine-Kinase Inhibitor

Key Eligibility Criteria:

Gender: All
Age: 18 Years and older (Adult, Older Adult)
Location of Metastases: 
Additional Notes: Only patients with HER2-negative breast cancer are eligible for phase 2
Exclusions: Patients with unstable and symptomatic brain metastasis – see trial for details
https://ClinicalTrials.gov/show/NCT05243641

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