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Therapy Name	Lapatinib
Synonyms
Therapy Description	Tykerb (lapatinib) reversibly inhibits ERBB2 (HER2) and EGFR, resulting in decreased downstream signaling and potentially leading to reduced tumor growth (PMID: 22477724). Tykerb (lapatinib) is FDA approved for ERBB2 (HER2)-positive (overexpressing) breast cancer (FDA.gov).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Lapatinib	Tykerb	Lapatinib Ditosylate	EGFR Inhibitor (Pan) 63 HER2 Inhibitor 44	Tykerb (lapatinib) reversibly inhibits ERBB2 (HER2) and EGFR, resulting in decreased downstream signaling and potentially leading to reduced tumor growth (PMID: 22477724). Tykerb (lapatinib) is FDA approved for ERBB2 (HER2)-positive (overexpressing) breast cancer (FDA.gov).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
PIK3CA E542K	breast cancer	sensitive	Lapatinib	Preclinical	Actionable	In a preclinical study, Tykerb (lapatinib) inhibited survival of transformed breast epithelial cell lines overexpressing PIK3CA E542K in culture (PMID: 26627007).	26627007
PIK3CA E545K	breast cancer	sensitive	Lapatinib	Preclinical	Actionable	In a preclinical study, Tykerb (lapatinib) inhibited survival of transformed breast epithelial cell lines overexpressing PIK3CA E545K in culture (PMID: 26627007).	26627007
PIK3CA G1049R	breast cancer	sensitive	Lapatinib	Preclinical	Actionable	In a preclinical study, Tykerb (lapatinib) inhibited survival of transformed breast epithelial cell lines overexpressing PIK3CA G1049R in culture (PMID: 26627007).	26627007
PIK3CA H1047L	breast cancer	sensitive	Lapatinib	Preclinical	Actionable	In a preclinical study, Tykerb (lapatinib) inhibited survival of transformed breast epithelial cell lines overexpressing PIK3CA H1047L in culture (PMID: 26627007).	26627007
PIK3CA H1047R	breast cancer	sensitive	Lapatinib	Preclinical	Actionable	In a preclinical study, Tykerb (lapatinib) inhibited survival of transformed breast epithelial cell lines overexpressing PIK3CA H1047R in culture (PMID: 26627007).	26627007
PIK3CA N345K	breast cancer	sensitive	Lapatinib	Preclinical	Actionable	In a preclinical study, Tykerb (lapatinib) inhibited survival of transformed breast epithelial cell lines overexpressing PIK3CA N345K in culture (PMID: 26627007).	26627007
PIK3CA Q546K	breast cancer	sensitive	Lapatinib	Preclinical	Actionable	In a preclinical study, Tykerb (lapatinib) inhibited survival of transformed breast epithelial cell lines overexpressing PIK3CA Q546K in culture (PMID: 26627007).	26627007

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT03784014	Phase III	Ceritinib Dabrafenib + Trametinib Capmatinib Durvalumab + Olaparib Nilotinib Futibatinib Trametinib Palbociclib Glasdegib Lapatinib	Molecular Profiling of Advanced Soft-tissue Sarcomas (MULTISARC)	Active, not recruiting	FRA	0
NCT04591431	Phase II	Everolimus Nivolumab Itacitinib Erlotinib Ponatinib Pemigatinib Ipatasertib Ipilimumab Cobimetinib Atezolizumab Palbociclib Entrectinib Vemurafenib Lapatinib Trastuzumab Brigatinib Alectinib Ado-trastuzumab emtansine Pertuzumab Vismodegib	The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy (ROME)	Active, not recruiting	ITA	0
NCT00790816	Phase I	Lapatinib + Paclitaxel Lapatinib Lapatinib + Trastuzumab Capecitabine + Lapatinib Lapatinib + Letrozole Capecitabine + Lapatinib + Oxaliplatin Gemcitabine + Lapatinib Docetaxel + Lapatinib Fluorouracil + Lapatinib + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Lapatinib + Leucovorin	Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-cancer Agents	Completed	USA \| NLD \| ESP \| CAN	1
NCT00863122	Phase I	Lapatinib	Concentration and Activity of Lapatinib in Vestibular Schwannomas	Completed	USA	0
NCT00939523	Phase II	Lapatinib	Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy	Completed	USA	0
NCT01160211	Phase III	Lapatinib + Trastuzumab Letrozole Anastrozole Lapatinib Trastuzumab Exemestane	A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer	Completed	USA \| TUR \| POL \| ITA \| ISR \| HUN \| HRV \| GRC \| GBR \| FRA \| ESP \| DEU \| BRA \| BGR \| BEL \| AUS \| ARG	12
NCT01306045	Phase II	Erlotinib Lapatinib MK2206 Sunitinib Selumetinib	Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies	Completed	USA	0
NCT01622868	Phase II	Lapatinib	Whole-Brain Radiation Therapy or Stereotactic Radiosurgery With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer	Completed	USA \| CAN	1
NCT02101905	Phase I	Lapatinib	Lapatinib Ditosylate Before Surgery in Treating Patients With Recurrent High-Grade Glioma	Completed	USA	0
NCT02551718	Phase I	Bosutinib Irinotecan Romidepsin Busulfan Melphalan Nilotinib Crizotinib Cytarabine Mitoxantrone Dasatinib Pazopanib Paclitaxel Clofarabine Hydroxyurea Tretinoin Carfilzomib Nelarabine Bexarotene Pentostatin Everolimus Cabozantinib Mercaptopurine Methotrexate Cladribine Thioguanine Daunorubicin Ponatinib Etoposide Afatinib Gefitinib Gemcitabine Regorafenib Arsenic trioxide Trametinib Imatinib Erlotinib Dabrafenib Decitabine Axitinib Azacitidine Ruxolitinib Fludarabine Lapatinib Ceritinib Sirolimus Sorafenib Lomustine Sunitinib Cabazitaxel Temsirolimus Topotecan Bortezomib Pralatrexate	High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia	Completed	USA	0
NCT02788201	Phase II	Erlotinib Thiotepa Imatinib Dacarbazine Arsenic trioxide Idarubicin Mitomycin C Thioguanine Mercaptopurine Methotrexate Cladribine Epirubicin Gemcitabine Doxorubicin Bleomycin Etoposide Gefitinib Daunorubicin Lomustine Sorafenib Sunitinib Ifosfamide Asparaginase Ixabepilone Abiraterone Azacitidine Ruxolitinib Decitabine Axitinib Estramustine Floxuridine Lapatinib Carmustine Fludarabine Nilotinib Cisplatin Vismodegib Vandetanib Melphalan Busulfan Carboplatin Toremifene Crizotinib Dactinomycin Temsirolimus Vorinostat Romidepsin Fluorouracil Irinotecan Bortezomib Tamoxifen Topotecan Chlorambucil Pentostatin Eribulin Carfilzomib Vemurafenib Hydroxyurea Exemestane Vincristine Sulfate Dasatinib Mitoxantrone Vinblastine Cytarabine Tretinoin Clofarabine Teniposide Docetaxel Pazopanib Oxaliplatin Streptozocin Paclitaxel Bendamustine Mechlorethamine Mitotane	Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma	Completed	USA	0
NCT02559778	Phase I	Bortezomib Crizotinib Lapatinib Vorinostat Eflornithine Sorafenib Dasatinib	Pediatric Precision Laboratory Advanced Neuroblastoma Therapy (PEDS-PLAN)	Recruiting	USA \| CAN	0
NCT00759642	Phase II	Lapatinib	Lapatinib in Women With Metastatic Breast Cancer Who Have Failed Prior Antihormone Therapy	Terminated	USA	0
NCT01427322	Phase I	Lapatinib	Randomized RT +/- Lapatinib for Advanced Solid Tumor Cancer Patients Receiving Radiation Therapy for Metastatic Disease	Terminated	USA	0
NCT01868503	Phase II	Lapatinib	Lapatinib Ditosylate and Radiation Therapy in Treating Patients With Locally Advanced or Locally Recurrent Breast Cancer	Terminated	USA	0

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