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|Therapy Name||Ado-trastuzumab emtansine + Palbociclib|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Ado-trastuzumab emtansine||Kadcyla||T-DM1|trastuzumab emtansine||HER2 (ERBB2) Antibody 58||Kadcyla (ado-trastuzumab emtansine) is an antibody drug conjugate combined of the ERBB2 (HER2) monoclonal antibody, trastuzumab, and an anti-tubulin agent, DM1, which results in tumor cell cytotoxicity (PMID: 24887180). Kadcyla (ado-trastuzumab emtansine) is FDA approved for metastatic ERBB2 (HER2)-positive (overexpression or gene amplification) breast cancer patients who have previously received trastuzumab and/or taxane, and for the adjuvant treatment of patients with ERBB2 (HER2)-positive early breast cancer who have residual invasive disease after taxane and trastuzumab-based treatment (FDA.gov).|
|Palbociclib||Ibrance||PD0332991||CDK4/6 Inhibitor 11||Ibrance (palbociclib) is a selective inhibitor of cyclin-dependent kinase 4 (CDK4) and 6 (CDK6) (PMID: 19874578). Ibrance (palbociclib) is approved in combination with an aromatase inhibitor in postmenopausal patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer, and in combination with Faslodex (fulvestrant) in patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT01976169||Phase I||Ado-trastuzumab emtansine + Palbociclib||Phase 1b Study of PD-0332991 in Combination With T-DM1(Trastuzumab-DM1)||Completed||USA||0|
|NCT03530696||Phase II||Ado-trastuzumab emtansine Ado-trastuzumab emtansine + Palbociclib||T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer (T-DM1)||Active, not recruiting||USA||0|