Therapy Detail
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| Therapy Name | Capecitabine + Neratinib |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Capecitabine | Xeloda | R340 | Chemotherapy - Antimetabolite 11 | Xeloda (capecitabine) is an antimetabolite that when activated to 5-FU ultimately inhibits DNA synthesis and cell division (NCI Drug Dictionary). |
| Neratinib | Nerlynx | HKI-272|PB272 | HER2 Inhibitor 25 | Nerlynx (neratinib) inhibits the ERBB2 (HER2) receptor as well as EGFR, resulting in decreased proliferation of HER2 and EGFR expressing tumor cells (PMID: 15173008). Nerlynx (neratinib) is FDA approved for use in patients with early stage ERBB2 (HER2)-positive breast cancer following Herceptin (trastuzumab)-based therapy, and in combination with Xeloda (capecitabine) in patients with advanced/metastatic ERBB2 (HER2)-positive breast cancer who have received two or more anti-ERBB2 (HER2) regimens (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 + Neratinib | FDA approved | Actionable | In a Phase III (NALA) trial that supported FDA approval, combination of Nerlynx (neratinib) and Xeloda (capecitabine) reduced risk of disease progression or death (HR=0.76, p=0.006), improved 12-month PFS (28.8%, 88/307 vs 14.8%, 46/314) compared to lapatinib and capecitabine combination in patients with metastatic ERBB2 (HER2)-positive (amp/over exp) breast cancer who had 2 or more prior ERBB2 (HER2)-targeted therapies (J Clin Oncol 37, no. 15_suppl (May 20, 2019) 1002-1002; NCT01808573). | detail... detail... |
| ERBB2 amp | Her2-receptor positive breast cancer | sensitive | Capecitabine + Neratinib | Guideline | Actionable | Nerlynx (neratinib) 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 positive | Her2-receptor positive breast cancer | sensitive | Capecitabine + Neratinib | Phase II | Actionable | In a Phase II trial, Nerlynx (neratinib) and Xeloda (capecitabine) combination therapy resulted in an overall 12-month survival rate of 63% (23/37) in patients with Erbb2 (Her2)-positive breast cancer brain metastases (J Clin Oncol 35, 2017 (suppl; abstr 1005)). | detail... detail... |
| ERBB2 over exp | Her2-receptor positive breast cancer | sensitive | Capecitabine + Neratinib | FDA approved | Actionable | In a Phase III (NALA) trial that supported FDA approval, combination of Nerlynx (neratinib) and Xeloda (capecitabine) reduced risk of disease progression or death (HR=0.76, p=0.006), improved 12-month PFS (28.8%, 88/307 vs 14.8%, 46/314) compared to lapatinib and capecitabine combination in patients with metastatic ERBB2 (HER2)-positive (amp/over exp) breast cancer who had 2 or more prior ERBB2 (HER2)-targeted therapies (J Clin Oncol 37, no. 15_suppl (May 20, 2019) 1002-1002; NCT01808573). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status |
|---|---|---|---|---|
| NCT01494662 | Phase II | Capecitabine + Neratinib Neratinib | HKI-272 for HER2-Positive Breast Cancer and Brain Metastases | Recruiting |
| NCT03377387 | Phase Ib/II | Capecitabine + Neratinib | Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer | Recruiting |
| 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 |
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