Therapy Detail

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Therapy Name Lapatinib + Trastuzumab
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Lapatinib Tykerb Lapatinib Ditosylate EGFR Inhibitor (Pan) 46 HER2 (ERBB2) Antibody 37 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).
Trastuzumab Herceptin Anti HER2 HER2 (ERBB2) Antibody 37 Herceptin (trastuzumab) is a monoclonal antibody, which binds ERBB2 (HER2) to induce tumor cellular cytotoxicity (PMID: 17611206). Herceptin (trastuzumab) is FDA approved for HER2-overexpressing (or amplification) breast cancer, gastric adenocarcinoma, and gastroesophageal junction adenocarcinoma (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ERBB2 amp stomach cancer sensitive Lapatinib + Trastuzumab Preclinical - Cell line xenograft Actionable In a preclinical study, the combination of Herceptin (trastuzumab) and Tykerb (lapatinib) treatment induced tumor regression in ERBB2 (HER2)-amplified cell line xenograft models of gastric cancer (PMID: 26296355). 26296355
ERBB2 amp Her2-receptor positive breast cancer sensitive Lapatinib + Trastuzumab Guideline Actionable Herceptin (trastuzumab) combined with Tykerb (lapatinib) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 T798M breast cancer sensitive Lapatinib + Trastuzumab Preclinical - Cell line xenograft Actionable In a preclinical study, human breast cancer cell lines and cell line xenografts expressing ERBB2 T798M demonstrated sensitivity to the combination of Herceptin (trastuzumab) and Tykerb (lapatinib) (PMID: 23948973). 23948973
ERBB2 L869R colorectal adenocarcinoma predicted - resistant Lapatinib + Trastuzumab Case Reports/Case Series Actionable In a clinical case study, a colorectal carcinoma patient who initially achieved stable disease following treatment with Tykerb (lapatinib) and Herceptin (trastuzumab) developed secondary resistance, presenting with a brain metastasis, and ERBB2 (HER2) L869R was identified in the brain lesion (PMID: 29941010). 29941010
ERBB2 over exp Her2-receptor positive breast cancer sensitive Lapatinib + Trastuzumab Guideline Actionable The combination of Herceptin (trastuzumab) and Tykerb (lapatinib) is included in guidelines for patients with ERBB2 (HER2)-positive advanced breast cancer who progressed on Herceptin (trastuzumab)-based therapy, however, the combination therapy is not recommended as neoadjuvant therapy for ERBB2 (HER2)-positive patients with early breast cancer (PMID: 31236598, PMID: 30032243; ESMO.org). detail... 30032243 31236598
ERBB2 over exp Her2-receptor positive breast cancer sensitive Lapatinib + Trastuzumab Guideline Actionable Herceptin (trastuzumab) combined with Tykerb (lapatinib) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 positive Her2-receptor positive breast cancer sensitive Lapatinib + Trastuzumab Clinical Study - Meta-analysis Actionable In a meta-analysis of six randomized clinical trials, Tykerb (lapatinib) and Herceptin (trastuzumab) combination treatment resulted in 13% absolute improvement in pathologic complete response rate in ERBB2 (HER2)-positive breast cancer patients compared to Herceptin (trastuzumab) single treatment (PMID: 27140927). 27140927
ERBB2 positive Her2-receptor positive breast cancer sensitive Lapatinib + Trastuzumab Phase II Actionable In a Phase II trial, Tykerb (lapatinib) and Herceptin (trastuzumab) combination treatment resulted in complete response in the breast in 10.6% (7/66) and minimal residual disease in 16.7% (11/66) of ERBB2-positive breast cancer patients 11 days after receiving the treatment (European Breast Cancer Conference; Mar 2016; Abstract #6LBA). detail...
ERBB2 over exp PIK3CA H1047R Her2-receptor positive breast cancer resistant Lapatinib + Trastuzumab Preclinical Actionable In a preclinical study, a mouse breast cancer model with mammary ERBB2 (HER2) over-expression that also expressed the PIK3CA H1047R mutation showed resistance to the combination of Herceptin (trastuzumab) and Tykerb (lapatinib) (PMID: 23940356). 23940356
ERBB2 S310Y colorectal cancer sensitive Lapatinib + Trastuzumab Preclinical Actionable In a preclinical study, Herceptin (trastuzumab) and Tykerb (lapatinib) combination treatment resulted in tumor regression in xenograft models of patient derived colorectal cancer cells harboring ERBB2 (HER2) S310Y (PMID: 26243863). 26243863
BRAF wild-type ERBB2 amp NRAS wild-type colon cancer sensitive Lapatinib + Trastuzumab Guideline Actionable Herceptin (trastuzumab) in combination with Tykerb (lapatinib) is included in guidelines as second-line therapy for advanced or metastatic colon cancer patients with ERBB2 amplification and NRAS, BBRAF wild-type (NCCN.org). detail...
ERBB2 pos PIK3CA mut Her2-receptor positive breast cancer decreased response Lapatinib + Trastuzumab Clinical Study - Cohort Actionable In a clinical study, a retrospective analysis of the combined treatment, Herceptin (trastuzumab) and Tykerb (lapatinib), in ERBB2 (HER2) positive breast cancer patients demonstrated patients harboring a PIK3CA mutation trended towards a decreased response when compared to patients with wild-type PIK3CA (PMID: 28177460). 28177460
ERBB2 pos PIK3CA mut Her2-receptor positive breast cancer decreased response Lapatinib + Trastuzumab Phase II Actionable In a Phase II trial, ERBB2-positive breast cancer patients harboring PIK3CA mutations demonstrated lower pathologic complete remission rate (12.5%) compared to those with wild-type PIK3CA (48.4%) after Herceptin (trastuzumab) and Tykerb (lapatinib) combination therapy (PMID: 26245675). 26245675
ERBB2 amp colorectal cancer sensitive Lapatinib + Trastuzumab Preclinical - Pdx Actionable In a preclinical study, the combination of Herceptin (trastuzumab) and Tykerb (lapatinib) treatment induced tumor regression in patient-derived colorectal cancer tumorgraft models harboring ERBB2 (HER2) amplification (PMID: 26296355). 26296355
BRAF wild-type ERBB2 amp NRAS wild-type rectum cancer sensitive Lapatinib + Trastuzumab Guideline Actionable Herceptin (trastuzumab) in combination with Tykerb (lapatinib) is included in guidelines as second-line therapy for advanced or metastatic rectum cancer patients with ERBB2 amplification and wild-type NRAS and BRAF (NCCN.org). detail...
ERBB2 L755S ERBB2 amp Her2-receptor positive breast cancer resistant Lapatinib + Trastuzumab Preclinical - Cell culture Actionable In a preclinical study, breast cancer cell lines with ERBB2 (HER2) amplification and expressing ERBB2 L755S demonstrated decreased inhibition proliferation compared to cells expressing wild-type ERBB2 (HER2) following treatment with Herceptin (trastuzumab) and Tykerb (lapatinib) (PMID: 30301790). 30301790
ERBB2 L755S ERBB2 amp Her2-receptor positive breast cancer resistant Lapatinib + Trastuzumab Preclinical - Cell culture Actionable In a preclinical study, expression of ERBB2 (HER2) L755S conferred resistance to Tykerb (lapatinib) plus Herceptin (trastuzumab) combination therapy in ESR1-positive/ERBB2 (HER2)-positive breast cancer cells with ERBB2 amplification in culture (PMID: 28487443). 28487443

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Clinical Trial Phase Therapies Title Recruitment Status
NCT01273610 Phase II Lapatinib + Trastuzumab Tolerability of the Combination of Lapatinib and Trastuzumab in Adults Age 60 or Older With HER2 Positive Metastatic Breast Cancer Active, not recruiting
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
NCT02073487 Phase II Paclitaxel Ado-trastuzumab emtansine + Lapatinib Lapatinib + Trastuzumab Nab-paclitaxel Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab With Lapatinib and Paclitaxel Completed
NCT02213042 Phase II Lapatinib + Trastuzumab Trastuzumab Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer Completed
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 Active, not recruiting
NCT00968968 Phase III Trastuzumab Lapatinib + Trastuzumab Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone Terminated
NCT01875666 Phase I Lapatinib + Trastuzumab Trastuzumab Pertuzumab Pertuzumab + Trastuzumab Defining the HER2 Positive (+) Breast Cancer Kinome Response to Trastuzumab, Pertuzumab, Combination Trastuzumab +Pertuzumab, or Combination Trastuzumab + Lapatinib Completed


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