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Therapy Name | Ado-trastuzumab emtansine + Palbociclib |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Ado-trastuzumab emtansine | Kadcyla | T-DM1|trastuzumab emtansine | HER2 (ERBB2) Antibody 76 HER2 (ERBB2) Antibody-Drug Conjugate 31 | Kadcyla (ado-trastuzumab emtansine) is an antibody-drug conjugate (ADC) comprising 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|PD-0332991 | CDK4/6 Inhibitor 14 | 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 |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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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) | Completed | USA | 0 |