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Association details:
| Biomarker: | HER-2 amplification |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | Irene (pyrotinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor) |
| Direction: | Sensitive |
Evidence:
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:
Exploratory study on the efficacy of pyrotinib combined with capecitabine in the first-line treatment of asymptomatic brain metastasis of HER2 positive breast cancer
Excerpt:
...HER2 overexpression was histologically confirmed in primary and/or metastatic foci of breast cancer: immunohistochemical 3+ or 2+ and verified HER2 amplification was detected by fluorescence in situ hybridization (FISH) 3. ...
Trial ID:
More C2 evidence
Source:
Title:
Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer
Excerpt:
...HER-2 (3+) or HER-2 (0-2+) but amplified by FISH detection....
Trial ID:
Source:
Title:
Phase II Clinical Study of Pyrotinib in First-line Treatment of Primary HER2-amplified/Mutated Advanced Non-small Cell Lung Cancer
Excerpt:
...HER2 insertion mutation, primary HER2 point mutation or primary HER2 amplification confirmed by genetic testing of tumor tissue or blood, pleural effusion, cerebrospinal fluid and other specimens; 5....
Trial ID:
Source:
Title:
Real-world Study of Pyrotinib in Neoadjuvant Therapy for HER2-positive Breast Cancer
Excerpt:
...HER2 expression positive breast cancer confirmed by pathological examination, defined as an immunohistochemical (IHC) score of 3 + in > 10% of immunoreactive cells or HER2 gene amplification by in situ hybridization (ISH) results (HER2 gene signal to centromere 17 signal ratio ≥ 2.0 or HER2 gene copy number ≥ 6)....
Trial ID:
Source:
Title:
A Real-World Study of Pyrotinib Maleate in the Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer With Rare Mutations in HER2
Excerpt:
...HER2 mutation and amplification confirmed by gene testing of tumor tissue or blood, pleural effusion, cerebrospinal fluid and other specimens;...
Trial ID:
Source:
Title:
Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors
Excerpt:
...- have confirmed HER2 gene amplified tumor fluorescence in-situ hybridization (FISH, HER2/cep17 ratio > 2) or HER2 overexpression (IHC 3+) or documented HER2 gene mutation....
Trial ID:
Source:
Title:
Pyrotinib Combined With Pemetrexed Plus Carboplatin in the First-line Treatment
Excerpt:
......
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:
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:
The Basket Study of Pyrotinib Maleate for HER2-Postive Solid Tumor
Excerpt:
...HER2 positive: refers to standard immunohistochemical staining (IHC) assay showing HER2 is 3+ and / or fluorescence in situ hybridization (FISH) positive or after second generation sequencing shows HER2 amplification and copy number ≥ 3, or There is a HER2 activating mutation identified by the Molecular Oncology Committee (confirmed by the investigator at the test center) ; 6....
Trial ID:
Source:
Title:
Phase II Clinical Study of Pyrotinib Combined With Etoposide to Treat HER2-positive Advanced Breast Cancer
Excerpt:
...Pathologically confirmed HER2-expressing patients with locally advanced or metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification 6....
Trial ID:
Source:
Title:
Pyrotinib Combined With Capecitabine Metronomic Therapy in HER2-postitive Advanced Breast Cancer
Excerpt:
...Pathologically confirmed HER2-expressing patients with locally advanced or metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification 6....
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:
Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Excerpt:
...Histologically or cytologically confirmed HER2-negative (0 or 1+ by immuno-histochemical (IHC) or non-amplified by FISH) breast cancer that is stage IV....
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:
A multicentre, retrospective real-world study of pyrotinib in the treatment of HER2-positive advanced breast cancer
Excerpt:
...HER-2 positivity was confirmed by histopathological test: immunohistochemistry(IHC) results of 3 + or in situ hybridization (ISH) results of amplification of HER2 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:
Less C2 evidence
Source:
Title:
Safety and efficacy of pyrotinib in patients with NSCLC and other advanced solid tumors with activating HER2 alterations: A phase I basket trial.
Published date:
05/28/2020
Excerpt:
A total of 62 pts were enrolled...24 pts with HER2-mutant NSCLC (20, i.e. 65% of which were the A775_G776insYVMA mutation) and 18 pts with HER2-mutant or amplified solid tumors completed end of Cycle 2 imaging scan and were evaluable for tumor responses. The ORR was 19% (8/42, 95% CI 7-31%); confirmed responses include a complete response (CR)...and 4 PRs in HER2-amplified cholangiocarcinoma, ovarian, endometrial and salivary gland carcinomas....Pyrotinib demonstrated a manageable safety profile and encouraging efficacy in pts with heavily pre-treated HER2-mutant NSCLC.
DOI:
10.1200/JCO.2020.38.15_suppl.3510
Trial ID:
