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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | Irene (pyrotinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Pyrotinib for locally advanced or metastatic HER2-positive breast cancer: a randomized, open, phase II clinical trial
Excerpt:
...(1) Signed Informed Consent Form(ICF); (2) Women aged 18 to 75 years; (3) Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1; (4) Expected survival more than 12 weeks; (5) Histologically or cytologically confirmed invasive breast cancer, including locally advanced breast cancer (stage IIIb, stage IIIc) or recurrent and metastatic breast cancer; (6) HER2 positive confirmed by our laboratory tests (HER2 positive definition: IHC 3+ or FISH +); (7) At least one measurable lesion according to RECIST version 1.1 criteria; (8) Disease progress after or during trastuzumab treatment: receive continuous trastuzumab ≥ 2 cycles during relapse/metastasis; or continuous use of trastuzumab ≥ 3 months during adjuvant therapy; (9) Adequate organ function within 7 days prior to the first study treatment: 1) Neutrophil (ANC) >= 1.5x10^9/L, platelet count (PLT) >= 90x10^9/L, hemoglobin >=90 g/L; 2) Serum total bilirubin (TBIL) <= 1.5xthe upper limit of nomal(ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.0xULN, and ALT and AST <= 5xULN in patients with liver metastases; Urea nitrogen (BUN) and creatinine (Cr) <= 1.5xULN; 3) Baseline LVEF >= 50% by ECHO; 4) The QT interval (QTcF) corrected by the Fridericia method is <470 msec....
Trial ID:
Source:
Title:
Efficacy and Safety of Pyrotinib in Patients With HER2 Mutation Advanced Non-Small Cell Lung Cancer
Excerpt:
...- Histologically or cytologic confirmed HER2 positive advanced Non-small cell lung cancer who failed prior therapies....
Trial ID:
More C2 evidence
Source:
Title:
Nab-paclitaxel in Combination With Pyrotinib in Postoperative Adjuvant Therapy for HER2-positive Breast Cancer
Excerpt:
...- Enrollment subjects must have a pathological diagnosis of HER2-positive primary invasive breast cancer with an immunohistochemistry (IHC) score of 3 +, or 2 + and HER2 gene amplification by in situ hybridization (ISH) (ratio of HER2/CEP17 ≥ 2.0)....
Trial ID:
Source:
Title:
Study Evaluating Pyrotinib/Pyrotinib in Combination With Docetaxel in Patients With HER2+ Advanced Gastric Cancer
Excerpt:
...- Histologically or cytologic confirmed HER2 positive advanced gastric cancer (including adenocarcinoma of esophageal-gastric junction), with clinical phase III/IV....
Trial ID:
Source:
Title:
Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer
Excerpt:
......
Trial ID:
Source:
Title:
A Study of Pyrotinib Plus Capecitabine Combined With SRT in HER2+ MBC With Brain Metastases
Excerpt:
...HER2-positive breast cancer is confirmed by the pathology laboratory with an immunohistochemical (IHC) score of 3+ and/or 2+ and a positive in situ hybridization (ISH) test (ISH amplification rate ≥ 2.0) 4....
Trial ID:
Source:
Title:
A Phase II Clinical Study of Treatment With Disitamb Vedotin Plus Pyrotinib in HER2-positive Early Breast Cancer
Excerpt:
...Histologically confirmed HER2 positive...
Trial ID:
Source:
Title:
Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer
Excerpt:
...- Histologically confirmed invasive HER2 positive breast cancer;...
Trial ID:
Source:
Title:
Pharmacokinetic Study of Pyrotinib and Docetaxel in Combination With Trastuzumab in Patients With HER2 Metastatic Breast Cancer
Excerpt:
...HER2 positive recurrent or metastasis breast cancer....
Trial ID:
Source:
Title:
Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer
Excerpt:
...HER2 positive breast cancer (IHC 3+, or IHC 2+ and FISH positive); lymph node positive, except for T0; lymph node negative and tumor >1cm, or tumor > 0.5 cm and ≤ 1cm, and accompanied by any of the following high-risk factors: pathological grade 3, ER/PR negative, or < 35 years old; 4....
Trial ID:
Source:
Title:
Pyrotinib in Women With High-risk in Early Stage Breast Cancer
Excerpt:
...Patients with HER2+ early or locally advanced breast cancer confirmed by histopathology: HER2-positive is defined by standard of 3+ by immunohistochemical staining (IHC), or 2+ by immunohistochemical staining (IHC) but positive by in situ hybridization (ISH)....
Trial ID:
Source:
Title:
A Study of Pyrotinib in Combination With Trastuzumab and Docetaxel in Patients With HER2 Metastatic Breast Cancer
Excerpt:
...HER2 positive recurrent or metastasis breast cancer....
Trial ID:
Source:
Title:
A Study of Pyrotinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer
Excerpt:
...Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies....
Trial ID:
Source:
Title:
Pyrotinib Combined With Capecitabine in HER-2 Positive Advanced Breast Cancer and Brain Metastases (Post-PERMEATE)
Excerpt:
...Positive HER2 expression refers to at least one tumor cell immunohistochemical staining intensity of 3+ or fluorescence in situ hybridization [FISH] in the pathological detection/recheck of the primary or metastatic lesions performed by the pathology department of the participating central hospital confirmed positive; 2....
Trial ID:
Source:
Title:
Pyrotinib Plus Vinorelbine in Participants With HER2-positive Previously Treated Locally Advanced or Metastatic Breast Cancer
Excerpt:
...- HER2 status must be prospectively, centrally tested and be HER2-positive based on central laboratory assay results...
Trial ID:
Source:
Title:
An Exploratory Basket Study of Pyrotinib Maleate Tablets in HER2 Mutated or Amplified of Metastatic Solid Tumors
Excerpt:
...Cancer tissue pathology is clearly HER2 positive: including IHC2+/ISH+, IHC 3+ or HER2 mutations (the results obtained by NGS method, PCR method, Sanger method, mass spectrometry sequencing and other measurement methods are all acceptable)....
Trial ID:
Source:
Title:
Pyrotinib in Combination With Letrozole in Patients With HER2-Positive, ER-Positive Metastatic Breast Cancer
Excerpt:
...- HER2 positive: HER2 IHC 3+, or HER2 IHC 2+ and ISH positive -...
Trial ID:
Source:
Title:
Efficacy and Safety of Pyrotinib in HER2 Positive Gastrointestinal Tumors
Excerpt:
...At least one measurable lesion exists.(RECIST 1.1) Histologically or cytologic confirmed HER2 positive gastrointestinal tumors who failed prior therapies....
Trial ID:
Source:
Title:
Treatment With Pyrotinib-Based Therapy in Lapatinib Resistant HER2-Positive Metastatic Breast Cancer
Excerpt:
...- Metastatic or locally recurrent HER2-positive breast cancer...
Trial ID:
Source:
Title:
18F-FDG Uptake Heterogeneity Predicts Pyrotinib Response
Excerpt:
...- Pathologically confirmed HER2 positive breast cancer...
Trial ID:
Source:
Title:
Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors
Excerpt:
...Patients with HER2 positive (defined as documented overexpression or amplification or mutation) metastatic breast cancer who have experienced disease progression following at least 2 prior anti-HER2 therapies for metastatic disease that contain trastuzumab with or without pertuzumab, prior T-DM1, or lapatinib therapy is required; 2....
Trial ID:
Source:
Title:
Pyrotinib in Combination With Fulvestrant in Patients With HER2 Positive，HR-Positive Metastatic Breast Cancer
Excerpt:
...Pathologically confirmed HER2 positive, hormone receptor-positive patients with locally advanced or metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification, ER（estrogen receptor） and/or PR（progesterone receptor） Immunohistochemical staining of more than 10% tumor cells) 2....
Trial ID:
Source:
Title:
Fulvestrant or Capecitabine Combined With Pyrotinib in HR+/HER2+ Metastatic Breast Cancer
Excerpt:
...immunohistochemical staining of tumor cells ≥ 10%; HER-2 positive: immunohistochemical staining of 3 + or fish positive); 3....
Trial ID:
Source:
Title:
Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer. (PHOEBE)
Excerpt:
...Histologically or cytologic confirmed HER2 positive metastatic breast cancer....
Trial ID:
Source:
Title:
Real World Study of Pyrotinib in Human Epidermal Growth Factor Receptor-2 (HER2) Positive Breast Cancer
Excerpt:
...≥18 years old with histologically confirmed HER2 positive breast cancer....
Trial ID:
Source:
Title:
A Study of Pyrotinib Combined With Capecitabine for Metastatic HER-2 Positive Colorectal Cancer
Excerpt:
...Patients with HER2 positive； 3....
Trial ID:
Source:
Title:
The Basket Study of Pyrotinib Maleate for HER2-Postive Solid Tumor
Excerpt:
...Patients with HER2-positive solid tumors confirmed by pathology and identified as advanced tumors by clinicians or centers; 5....
Trial ID:
Source:
Title:
Pyrotinib Plus Fulvestrant in Patients With HR+/HER2+ Metastatic Breast Cancer (Pyrotinib+Fulvestrant )
Excerpt:
...Women aged 18-75 years old; HR positive and HER2 positive (immunohistochemistry or FISH test confirmed)....
Trial ID:
Source:
Title:
A Study of Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer
Excerpt:
...Histologically confirmed HER2 positive advanced breast cancer....
Trial ID:
Source:
Title:
Pyrotinib in Combination With Nab-paclitaxel in Patients With HER2-positive Advanced Breast Cancer: an Exploratory Study
Excerpt:
...Pathologically confirmed HER2-positive invasive breast cancer by local laboratory with the following requirements: HER2 overexpressed or amplified (immunohistochemistry of 3+ or HER2 gene amplification by in situ hybridization) 3....
Trial ID:
Source:
Title:
A Real-world Clinical Study of Pyrotinib Maleate Tablets in the Treatment of Breast Cancer Patients With Positive Her-2
Excerpt:
...Confirmed by pathological examination of breast cancer patients with positive her-2 expression 3....
Trial ID:
Source:
Title:
Pyrotinib Combined With Docetaxel in the First-line Treatment of HER2-positive MBC
Excerpt:
...- HER2-positive breast cancer(according to 2018 ASCO/CAP HER2 test guideline)....
Trial ID:
Source:
Title:
Study Evaluating Pyrotinib in Combination With Capecitabine In Patients With HER2 Positive Metastatic Breast Cancer
Excerpt:
...- Histologically or cytologic confirmed HER2 positive metastatic breast cancer which failed prior therapies....
Trial ID:
Source:
Title:
Study of Pyrotinib in Patients With Human Epidermalgrowth Factor Receptor 2 (HER2) Positive Advanced Breast Cancer
Excerpt:
...- Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies....
Trial ID:
Source:
Title:
A real-world clinical study of pyrotinib maleate tablets in the treatment of her-2 positive breast cancer patients
Excerpt:
...Advanced breast cancer patients with positive her-2 expression confirmed by pathological examination; 3. ...
Trial ID:
Source:
Title:
The real world study of pyrotinib in the treatment of HER2 positive early breast cancer
Excerpt:
...Early breast cancer patients diagnosed as HER2 positive by pathology or histocytology; 3. ...
Trial ID:
Source:
Title:
A multicenter, prospective, single-arm, exploratory clinical study of neoadjuvant therapy of her2-positive breast cancer with pyrotinib maleate tablets combined with paclitaxel for injection (albumin bound)
Excerpt:
...Breast cancer with positive HER2 expression confirmed by pathological tests was defined as >10% immunoreactive cells with 3+ immunohistochemical (IHC) fraction or in situ hybridization (ISH) result of HER2 gene amplification (ratio of HER2 basal signal to centromeres 17 signal >= 2.1 or HER2 gene copy number >= 6). ...
Trial ID:
Source:
Title:
Real-world study for pyrotinib in the treatment of HER2-positive advanced breast cancer
Excerpt:
...HER2-positive advanced breast cancer patients diagnosed by pathology or histology; 3. ...
Trial ID:
Source:
Title:
Singal-arm, prospective and open phase II clinical trial for pyrotinib maleate tablets combined with paclitaxel for injection (albumin-binding) in the treatment of HER-2 positive advanced breast cancer
Excerpt:
...Pathologically confirmed advanced breast cancer patients with positive HER-2 expression; 5. ...
Trial ID:
Source:
Title:
A multicenter real-world study of pyrotinib maleate tablets in the treatment of HER2-positive breast cancer before surgery
Excerpt:
...Histopathological examination confirmed invasive breast cancer and HER2 positive; 3. ...
Trial ID:
Source:
Title:
Neoadjuvant pyrotinib in patients with HER2-positive breast cancer：a multicentre, retrospective real-world study
Excerpt:
...Histopathological examination confirmed invasive breast cancer with positive HER2; 3. ...
Trial ID:
Source:
Title:
Phase II exploratory, randomized, open-label, multicenter clinical study of probiotics combined with or without loperamide in the prevention of pyrotinib-induced diarrhea
Excerpt:
...Female patients with HER2-positive breast cancer, aged 18-65 years; 3. ...
Trial ID:
Source:
Title:
An exploratory basket study of non-breast cancer patients with HER2 mutation or amplification who failed in standard treatment with pyrotinib maleate tablets
Excerpt:
...Cancer tissue pathology is clearly HER2 positive: including IHC2+/ISH+, IHC 3+ or HER2 mutations (the results obtained by NGS method, PCR method, Sanger method, mass spectrometry sequencing and other measurement methods are all acceptable). ...
Trial ID:
Source:
Title:
A multicenter, single-arm, prospective, open-label clinical study of pyrotinib maleate tablets combined with TH regimen in the treatment of HER-2 positive early or locally advanced breast cancer before surgery
Excerpt:
......
Trial ID:
Source:
Title:
Pyrotinib as neoadjuvant treatment for HER2-positive breast cancer
Excerpt:
...Pathologically or histologically confirmed HER2-positive breast cancer patients; 3. ...
Trial ID:
Source:
Title:
A real-world study on the efficacy and safety of pyrotinib in the treatment of HER-2 positive metastatic breast cancer
Excerpt:
...For patients with stage IV HER-2 positive breast cancer confirmed by histopathology as recurrence and metastasis or inoperable at the time of diagnosis, HER-2 positive breast cancer was defined as primary or metastatic foci, and HER-2 positive tissue samples were 3 + by immunohistochemistry or + by fluorescence in situ hybridization (FISH); 2. ...
Trial ID:
Source:
Title:
Pyrotinib Plus Paclitaxel in the Second-Line Treatment of HER2-Amplified Advanced Gastric Cancer
Excerpt:
...Histologically proven adenocarcinoma of G/GEJ HER2 positivity (IHC3+ or ICH 2+ and HER2/CEP17 ratio greater than 2.0 on FISH) assessed before the first-line chemotherapy and refractory to fluoropyrimidine, platinum, and trastuzumab combination therapy. ...
Trial ID:
Source:
Title:
Pyrotinib in Combination With Albumin–Bound Paclitaxel in HER2-Positive Patients With Advanced Breast Cancer: a Multicentre Phase II Study
Excerpt:
...Pathologically confirmed HER2-positive invasive breast cancer by local laboratory with the following requirements: HER2 overexpressed or amplified (immunohistochemistry of 3+ or HER2 gene amplification by in situ hybridization) (ISH) positive (ISH amplification rate >= 2.0). ...
Trial ID:
Source:
Title:
A real-world study of pyrotinib maleate in the treatment of brain metastases from HER2-positive solid tumors
Excerpt:
...HER2-positive (gene mutation, gene amplification, protein overexpression) solid tumor confirmed by histology or cytology; 3. ...
Trial ID:
Source:
Title:
Pyrotinib Maleate combined with chemotherapy for advanced recurrent/metastatic breast cancer with HER 2-positive, hormone receptor low-positive/negative -A single-arm, multicenter, exploratory clinical study
Excerpt:
...Breast cancer patients with HER2 positive, low HR (1%-9%) or HR- determined by immunohistochemistry or fluorescence in situ hybridization; 3. ...
Trial ID:
Source:
Title:
A single-arm, single center, phase II study of RC48 combined with Pyrotinib in the treatment of HER-2 positive advanced breast cancer patients with brain metastases
Excerpt:
......
Trial ID:
Source:
Title:
Pyrotinib as neoadjuvant treatment for HER2-positive breast cancer: a single-arm, multi-center, prospective observational trial
Excerpt:
...Patients were HER2-positive by immunohistochemistry (IHC 3+) or by fluorescence in situ hybridisation (mandatory for IHC2+ tumors); 5. ...
Trial ID:
Source:
Title:
A multicentre, retrospective real-world study of pyrotinib in the treatment of HER2-positive advanced breast cancer
Excerpt:
...HER2 positive advanced breast cancer diagnosed by pathology, cytology or radiology, including inoperable breast cancer with stage IV, or recurrent/metastatic breast cancer. ...
Trial ID:
Source:
Title:
An open-label, single-arm, prospective phase Ib-II clinical study investigating the efficacy and safety of abeccil, fulvestrant combined with pyrotinib in the treatment of endocrine-resistant HR+/HER2+ advanced breast cancer
Excerpt:
...Pathological examination confirmed ER and/or PR positive, HER2 positive (ER expression: immunohistochemical staining of tumor cells >= 10%; PR expression: immunohistochemical staining of tumor cells >= 10%; HER-2 positive: immunohistochemical staining 3+ or FISH positive); 5. ...
Trial ID:
Less C2 evidence
Source:
Title:
Pyrotinib maleate for the treatment of brain metastases from HER2-positive solid tumours: A real-world study.
Published date:
05/25/2023
Excerpt:
Pivotally, pyrotinib has shown good clinical efficacy in patients with HER2-positive solid tumor brain metastases. The results of this study suggest that early intervention with intracranial local radiation therapy is utterly essential for HER2-positive patients with brain metastases at baseline.
DOI:
10.1200/JCO.2023.41.16_suppl.e13041
