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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | Nerlynx (neratinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor) |
| Direction: | Resistant |
Evidence:
Title:
CANBRIDGE PHARMACEUTICALS RECEIVES MARKETING APPROVAL FOR NERLYNX® (NERATINIB) IN TAIWAN
Excerpt:
BEIJING & SHANGHAI--CANbridge Pharmaceuticals Inc., a biopharmaceutical company developing innovative drug candidates to treat underserved medical conditions, announced that it has received marketing approval from the Taiwan Food and Drug Administration for NERLYNX® (neratinib) for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy.
Source:
Title:
An open label phase II study to evaluate neratinib for treatment and prevention of subsequent CNS event(s) in patients with brain metastasis of advanced HER2 positive breast cancer
Excerpt:
...Subjects must meet all of the following criteria in order to be eligible for this study:1) Age ≥ 18 years old2) ECOG performance status ≤ 2 3) Female 4) Diagnosis : histologically or cytologically confirmed HER2-positive tumour status according to the ASCO-CAP guidelines (defined as a 3+ score on immunohistochemistry (IHC) and/or positive by in situ hybridisation (ISH)) with brain metastases, estrogen receptor and progesteron receptor statusCohort 1: with CNS metastases pre-treated with local approaches for the previous CNS events and currently progressive but locally treated CNS metastasis Cohort 2: with a first diagnosis of CNS metastases, asymptomatic or paucisymptomatic not needing immediate local therapy Cohort 3: with confirmed LM defined as the presence of malignant cells in the CSF or combination of typical symptoms and MRI findings5) Specific criteria for cohorts 1 and 2 only: Must have radiologically confirmed metastatic brain lesion by MRI measurable by RANO-BM criteria 6) Specific criteria for cohort 3 only: LM defined as the presence of malignant cells in the CSF or combination of typical symptoms and MRI findings for cohort 37) Subjects should have received at least 1 previous line for the metastatic disease including taxanes based chemotherapy in combination with trastuzumab and pertuzumab (if available) unless contraindicated. ...
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:
...- Histologically confirmed Stage IB through Stage IIIC primary adenocarcinoma of the breast.- Documented HER2-positive disease based on local laboratory determination according to ASCO/CAP 2018 criteria. ...
Trial ID:
More C2 evidence
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:
...Breast cancer must be determined to be HER2-positive prior to randomization. ...
Trial ID:
Source:
Title:
Neratinib in combination with vinorelbine in metastatic breast cancer patients
Excerpt:
...Confirmed pathologic diagnosis of ErbB-2-positive breast cancer (current stage IV) in female subjects for which vinorelbine plus HKI-272 is a reasonable treatment option (part 2 only).4. ...
Trial ID:
Source:
Title:
Evaluation of Neratinib for Treatment and Prevention of Subsequent CNS Event(s) in Patients With Brain Metastasis of Advanced HER2 Positive Breast Cancer
Excerpt:
...Diagnosis : histologically or cytologically confirmed HER2-positive tumour status according to the ASCO-CAP guidelines (defined as a 3+ score on immunohistochemistry (IHC) and/or positive by in situ hybridisation (ISH)) with brain metastases, estrogen receptor and progesteron receptor status Cohort 1: with CNS metastases pre-treated with local approaches for the previous CNS events and currently progressive but locally treated CNS metastasis Cohort 2: with a first diagnosis of CNS metastases, asymptomatic or paucisymptomatic...
Trial ID:
Source:
Title:
Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast
Excerpt:
...- Patients with multifocal breast cancer are included as long as none of the tumors are HER2 positive by IHC or FISH and targeted lesion meets current...
Trial ID:
Source:
Title:
Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib
Excerpt:
...Documented HER2-positive disease based on local laboratory determination according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) 2018 criteria....
Trial ID:
Source:
Title:
Fulvestrant + Neratinib In Breast Cancer
Excerpt:
...ER, PR, and HER2 positivity would be determined per institutional (local) testing, with HR+/HER2 nonamplified (negative) status for this trial determined as per 2020 ASCO/CAP guidelines, in a biopsy/surgical specimen analyzed for ER/PR/HER2....
Trial ID:
Source:
Title:
Neratinib in Treating Older Patients With Stage IV HER2-Positive Breast Cancer
Excerpt:
...- HER2 positivity as defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines...
Trial ID:
Source:
Title:
Neratinib Dose Escalation Regimen for HER2 Positive Early Breast Cancer
Excerpt:
...- HER2 positive breast cancer diagnosed histologically is defined as HER2 (3+) by immunohistochemistry or HER2 (2+) with positive FISH test；...
Trial ID:
Source:
Title:
Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
Excerpt:
...- Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease....
Trial ID:
Source:
Title:
Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer
Excerpt:
......
Trial ID:
Source:
Title:
Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer
Excerpt:
...- ErbB-2 positive locally recurrent or metastatic breast cancer...
Trial ID:
Source:
Title:
A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer
Excerpt:
...- HER2 positive tumor...
Trial ID:
Source:
Title:
A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer
Excerpt:
...- HER2 positive breast cancer...
Trial ID:
Source:
Title:
Efficacy and safety of Disitamab Vedotin plus pyrotinib or naratinib in HER2-positive breast cancer patients with brain metastasis
Excerpt:
...1) Patients who can voluntarily sign an informed consent form; 2) Females aged ≥18 years old when signing the informed consent form; 3) ECOG PS physical status score of 0 to 2 points; 4) Histologically confirmed HER2-positive metastatic breast cancer patients; Note: HER2 positivity refers to at least one occurrence of tumor cell immunohistochemical staining intensity of 3+ or confirmed as positive by fluorescence in situ hybridization [FISH] in the pathological testing/re-review of the primary or metastatic lesions conducted by the participating center's pathology department; 5) Brain metastases confirmed by MRI/enhanced CT, with at least one measurable lesion in the brain based on RECIST 1.1 criteria; 6) Expected survival period ≥3 months; 7) Patient types: Cohort A - newly diagnosed brain metastases patients; Cohort B - patients with progression after whole-brain radiotherapy or stereotactic radiosurgery; 8) Left ventricular ejection fraction (LVEF) ≥50%; 9) QT interval corrected by Fridericia formula (QTcF) of 12-lead electrocardiogram: <450ms for males, <470ms for females; 10) The following conditions should be met in the blood routine examination:① Absolute neutrophil count (ANC) ≥1.5×10^9/L, ② Platelet count ≥100×10^9/L, ③ Hemoglobin ≥90g/L, ④ White blood cell count ≥3.0×10^9/L; 11) Liver function meets the following conditions: ① Serum total bilirubin ≤1.5×upper limit of normal (ULN), or ≤3×ULN if there are liver metastases, ② Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3×ULN, or ≤5×ULN if there are liver metastases; 12) Renal function meets the following conditions: Serum creatinine ≤1.5×ULN or creatinine clearance ≥50mL/min (calculated according to the Cockroft-Gault formula); 13) Female patients who meet the following conditions can participate in this study: ① Infertility; ② Capable of fertility, with a negative blood pregnancy test result within 7 days before the first administration of the investigational drug, not breastfeeding, and adopting effective contraceptive measures during the screening period, throughout the study, and within 6 months after the last administration of the study drug....
Trial ID:
Source:
Title:
Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer
Excerpt:
...Overall Response Rate (ORR), subjects with CR or PR by independent review in subjects with ErbB-2-positive breast cancer treated at the MTD of neratinib in combination with vinorelbine per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.`...
Trial ID:
Source:
Title:
Phase 1/2 Randomized, Open-label, Three Arm Study of Neratinib (HKI-272) vs. Neratinib + Capecitabine vs. Lapatinib + Capecitabine, in Subjects with Solid Tumors and ErbB-2 Positive Metastatic or locally advanced Breast Cancer
Excerpt:
...The primary end-point of this study is to assess the safety and define the maximum tolerated dose of the combination of neratinib with capecitabine in subjects with solid tumors, and to compare the objective response rate (ORR = CR + PR) for subjects with erbB-2 positive breast cancer treated at the MTD of neratinib in combination with capecitabine versus neratinib monotherapy versus lapatinib in combination with capecitabine.`...
Trial ID:
Source:
Title:
Neratinib adjuvant study
Excerpt:
...Subjects must have histologically confirmed primary adenocarcinoma of the breast that is erbB-2 positive by one of the following assays, performed locally: Fluorescence in Situ Hybridization (FISH) or Silver in Situ Hybridization (SISH), or Chromogenic in Situ Hybridization (CISH), or Immunohistochemistry assay.2. ...
Trial ID:
Source:
Title:
A Phase 2 Randomized Open Label Study of Neratinib versus Lapatinib plus Capecitabine for the treatment of ErbB-2 Positive Locally Advanced or Metastatic Breast Cancer
Excerpt:
...The primary endpoint is the comparison of the investigator assessed progression-free survival (PFS) following treatment with single agent neratinib versus lapatinib plus capecitabine in subjects with erbB-2-positive locally advanced or metastatic breast cancer. ...
Trial ID:
Less C2 evidence
Source:
Title:
Timing of initiation of neratinib after trastuzumab-based adjuvant therapy in early-stage HER2+ hormone receptor (HR)-negative breast cancer: Exploratory analyses from the phase III ExteNET trial.
Published date:
05/16/2018
Excerpt:
Patients with HER2+ HR- tumors tend to recur early. The risk of recurrence is higher in patients who have recently completed trastuzumab-based therapy (reflected in the iDFS rates of the placebo group)
DOI:
10.1200/JCO.2018.36.15_suppl.549
Trial ID:
