Therapy Detail

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Therapy Name Capecitabine + Lapatinib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Capecitabine Xeloda R340 Chemotherapy - Antimetabolite 12 Xeloda (capecitabine) is an antimetabolite that when activated to 5-FU ultimately inhibits DNA synthesis and cell division (NCI Drug Dictionary).
Lapatinib Tykerb Lapatinib Ditosylate EGFR Inhibitor (Pan) 47 HER2 Inhibitor 26 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
ERBB2 amp Her2-receptor positive breast cancer sensitive Capecitabine + Lapatinib Guideline Actionable Tykerb (lapatinib) combined with Xeloda (capecitabine) 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...
Unknown unknown colon adenocarcinoma not applicable Capecitabine + Lapatinib Phase II Actionable In a Phase II trial, Tykerb (lapatinib) combined with Xeloda (capecitabine) demonstrated safety, but failed to show efficacy in patients with advanced refractory colorectal cancer (PMID: 22811876). 22811876
CDH1 R63* ERBB2 L869Q breast cancer predicted - sensitive Capecitabine + Lapatinib Case Reports/Case Series Actionable In a clinical case study, treatment with the combination of Tykerb (lapatinib) and Xeloda (capecitabine) resulted in prolonged response and reduction in liver metastasis in a metastatic breast cancer patient harboring ERBB2 L869Q and CDH1 R63* mutations (PMID: 26487584). 26487584
ERBB2 pos PIK3CA mut Her2-receptor positive breast cancer decreased response Capecitabine + Lapatinib Phase III Actionable In a Phase III trial, Tykerb (lapatinib) and Xeloda (capecitabine) combination treatment resulted in decreased median progression free survival (4.3 vs. 6.4 months), median overall survival (17.3 vs. 27.8 months), and overall response rate(17.1% vs. 39.7%) in ERBB2 (HER2) positive breast cancer patients harboring PIK3CA mutations compared to PIK3CA wild type patients (PMID: 26920887). 26920887
ERBB2 over exp Her2-receptor positive breast cancer sensitive Capecitabine + Lapatinib Guideline Actionable Tykerb (lapatinib) combined with Xeloda (capecitabine) 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 V659E lung non-small cell carcinoma predicted - sensitive Capecitabine + Lapatinib Case Reports/Case Series Actionable In a clinical case study, treatment with the combination of Tykerb (lapatinib) and Xeloda (capecitabine) resulted in eight months of progression-free survival followed by disease progression in a non-small cell lung cancer patient harboring ERBB2 (HER2) V659E (PMID: 32478891). 32478891
ERBB2 L755S ERBB2 amp Her2-receptor positive breast cancer predicted - resistant Capecitabine + Lapatinib Case Reports/Case Series Actionable In a clinical case study, a patient with previously treated metastatic hormone receptor (ESR1/PGR)-positive, ERBB2 (HER2)-positive breast invasive ductal carcinoma harboring ERBB2 (HER2) L755S with ERBB2 (HER2) amplification demonstrated rapid disease progression when treated with the combination of Xeloda (capecitabine) and Tykerb (lapatinib) (PMID: 33559918). 33559918
ERBB2 S310F gallbladder cancer predicted - sensitive Capecitabine + Lapatinib Case Reports/Case Series Actionable In a clinical case study, Tykerb (lapatinib) in combination with Xeloda (capecitabine) resulted in rapid clinical improvement and decrease of tumor size after 2 cycles of treatment in a patient with metastatic gallbladder cancer harboring ERBB2 (HER2) S310F (PMID: 31558980). 31558980
Unknown unknown stomach cancer not applicable Capecitabine + Lapatinib Phase II Actionable In a Phase II trial, Tykerb (lapatinib) and Xeloda (capecitabine) combination treatment resulted in partial response in 17.9% (12/67) and stable disease in 46.3% (31/67) of gastric cancer patients regardless of their ERBB2 (HER2) status, although increased Erbb3 (Her3) expression level correlated with higher response rate (PMID: 27325685). 27325685

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02650752 Phase I Capecitabine + Lapatinib Intermittent High-Dose Lapatinib in Tandem With Capecitabine for HER2 Overexpressed/Amplified Metastatic Breast Cancer With Central Nervous System (CNS) Metastases Completed USA 0
NCT01808573 Phase III Capecitabine + Lapatinib Capecitabine + Neratinib A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting (NALA) Completed USA | CAN 26
NCT03523585 Phase III Trastuzumab deruxtecan Capecitabine + Lapatinib Capecitabine + Trastuzumab DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] Active, not recruiting USA 14
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 | CAN 3
NCT03262935 Phase III Capecitabine + Lapatinib Trastuzumab Duocarmazine Eribulin + Trastuzumab Capecitabine + Trastuzumab Trastuzumab + Vinorelbine SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer (TULIP) Active, not recruiting USA | CAN 9


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