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Therapy Name | Capecitabine + Lapatinib |
Synonyms | |
Therapy Description | |
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). |
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 |
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 |