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Association details:
| Biomarker: | HR positive |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | Nerlynx (neratinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
08/31/2018
Excerpt:
Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy.
Source:
Title:
139P - HER2+/HR+ breast cancer patients at high risk of relapse derive benefit from extended adjuvant treatment with neratinib: An exploratory analysis from ExteNET study
Published date:
09/13/2021
Excerpt:
Out of 1334 HER2+/HR+ BC patients…Neratinib reduced the relative risk for 2-year iDFS by 48% compared with placebo…
Trial ID:
Source:
Title:
Continued efficacy of neratinib in patients with HER2-positive (HER2+) early-stage breast cancer: final overall survival (OS) analysis from the randomized phase 3 ExteNET trial
Published date:
03/12/2021
Excerpt:
ExteNET evaluated neratinib in women with early-stage HER2+ breast cancer who had completed adjuvant (+/– neoadjuvant) trastuzumab + chemotherapy. A positive trend was seen in the HR+ subgroup (n = 1631; absolute difference at 8 y 1.5%; HR = 0.80; 95% CI 0.58–1.12); descriptive analyses suggested greater benefits with neratinib in the HR+/≤1 y subgroup (n = 1334; absolute difference at 8 y 2.1%; HR = 0.79; 95% CI 0.55–1.13) and in the HR+/≤1 year subset with no pCR after neoadjuvant therapy (n = 295; absolute difference at 8 y 9.1%; HR = 0.47; 95% CI 0.23–0.92). Analyses suggested greater OS improvements with neratinib in subgroups including HR+/≤1 y and HR+/≤1 y...
Trial ID:
Source:
Title:
Neratinib as extended adjuvant therapy in patients with HER2- positive/HR-positive early breast cancer: German HTA-driven analyses from the ExteNET study
Published date:
03/12/2021
Excerpt:
Here we report analyses of the HR-positive subgroup (N = 1’631) from the ExteNET-trial (neratinib vs. placebo)…time-to-event analyses revealed a significant advantage in disease-free survival (DFS) for neratinib vs. placebo (HR [95%-CI]: 0.45 [0.29; 0.69]; p = 0.0002). These results were consistent with the analysis of distant disease-free survival at 2 years (DDFS; HR [95%-CI): 0.52 [0.32; 0,84]; p = 0.0082). The analysis after 5 years of follow-up confirmed the 2-year results (HR for DFS [95%-CI]: 0.57 [0.41; 0.78], p = 0.0005; 5-year DFS-rates: 91.2 vs. 86.8%; HR for DDFS [95%-CI]: 0.60 [0.42; 0.85], p = 0.0037; 5-year DDFS-rates: 92.7 vs. 88.7%). Extended adjuvant neratinib provides a clinically relevant benefit with further reduction of relapse risk in the curative situation of patients with co-positive early breast cancer.
Trial ID:
Source:
Title:
Final efficacy results of neratinib in HER2-positive hormone receptor-positive early-stage breast cancer from the phase III ExteNET trial
Published date:
10/06/2020
Excerpt:
Neratinib significantly improved iDFS in the HER2+/HR+/≤ 1-year population, and a similar trend was observed in patients with residual disease following neoadjuvant treatment. Numerical improvements in central nervous system events and OS were consistent with iDFS benefits and suggest long-term benefit for neratinib in this population.
DOI:
10.1016/j.clbc.2020.09.014
Trial ID:
Source:
Title:
Phase II study to evaluate diarrhoea discontinuations at 3 cycles in patients with early-stage HER2 positive, hormone receptor positive breast cancer treated with neratinib plus loperamide versus neratinib dose escalation plus loperamide administered as needed versus neratinib plus loperamide plus colesevelam Estudio fase II para evaluar la incidencia de abandono debida a diarrea en 3 ciclos de tratamiento en pacientes con cáncer de mama estadio temprano HER2 positivo, receptor hormonal positivo tratados con neratinib más loperamida frente a neratinib con escalada de dosis más loperamida administrada solamente según necesidad frente a neratinib más loperamida más colesevelam
Excerpt:
...- Documented hormone receptor-positive (HR+) disease, defined as oestrogen receptor (ER) and/or progesterone receptor (PR) ≥1% based on local laboratory determination.- Patients must have completed prior neoadjuvant/adjuvant trastuzumab-based therapy (eg, trastusuzmab-based treatments including trastuzumab-emantasine [T-DM1]) or experienced side effects that resulted in early discontinuation of trastuzumab-based therapy that have since resolved (pertuzumab therapy is accepted but not mandatory).- The last dose of trastuzumab-based therapy must have been given to the patient >2 weeks and ≤1 year (365 days) before first dose of neratinib.- Left ventricular ejection fraction (LVEF) ≥50% measured by multiple-gated acquisition scan (MUGA) or echocardiogram (ECHO). ...
Trial ID:
Source:
Title:
A study before surgery evaluating Regimens with Weekly Paclitaxel plus Neratinib or Trastuzumab or Neratinib and Trastuzumab Followed by Doxorubicin and Cyclophosphamide with Postoperative Trastuzumab in Women with Locally Advanced HER2-Positive Breast Cancer. Studio clinico precedente all'intervento chirurgico per valutare i regimi di Paclitaxel settimanale più Neratinib o Trastuzumab o Neratinib e Trastuzumab seguito da Doxorubicina e Ciclofosfamide con Trastuzumab postoperatorio in donne con tumore alla mammella HER2-positivo localmente avanzato.
Excerpt:
...Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors. ...
Trial ID:
Less C2 evidence
Source:
Title:
98P - Real-world effectiveness and safety of neratinib in the extended adjuvant treatment of patients with HER2+ early breast cancer (eBC) in the United States Community Oncology Setting (ID 314)
Published date:
05/07/2023
Excerpt:
The present study objective was to investigate neratinib effectiveness and tolerability in real-world clinical practice….The 12- and 24-month iDFS rates were 97.5% and 96.0%, respectively….Based on these US community oncology data, the real-world effectiveness of neratinib in patients with HER2+ HR+ eBC ≤ 1 year after completing current adjuvant trastuzumab based therapies is consistent with that observed in the ExteNET study.
Source:
Title:
83P - Impact of treatment duration of extended adjuvant therapy with neratinib in early stage HER2+ HR+ breast cancer after trastuzumab-based therapy on patient outcomes
Published date:
05/23/2020
Excerpt:
There were 2840 pts in the ITT population and 1334 patients who were HR+, <1-year. The table shows iDFS findings for HR+, <1-year pts and stratified by treatment duration (≤3, ≥11 months). Greater benefit was seen in pts who stayed on treatment for ≥11 months when compared to pts who received ≤3 months of treatment.
Trial ID:
