Biomarkers /
HER2 Positive
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Overview
Biomarker-Directed Therapies
HER2 Positive is a predictive biomarker for use of trastuzumab, lapatinib, pertuzumab, ado-trastuzumab emtansine, aromatase inhibitor, fam-trastuzumab deruxtecan, capecitabine, endocrine therapy, cisplatin, docetaxel, paclitaxel, carboplatin, fluorouracil, margetuximab, neratinib, pembrolizumab, pertuzumab/trastuzumab/hyaluronidase, trastuzumab/hyaluronidase, and tucatinib in patients.
Of the therapies with HER2 Positive as a predictive biomarker, 13 are FDA-approved and 13 have NCCN guidelines in at least one clinical setting.
Breast carcinoma, adenocarcinoma of the gastroesophageal junction, colorectal carcinoma, gastric carcinoma, and malignant salivary gland neoplasm have the most therapies targeted against HER2 Positive or its related pathways [5].
Ado-Trastuzumab Emtansine +
Breast Carcinoma -
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Biomarker Criteria:
Sample must match all of the following:
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Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Adjuvant (FDA, NCCN), Metastatic (FDA, NCCN) | |
| Note: Indicated (as a single agent) for the treatment of patients with HER2+ positive breast cancer in either the adjuvant or metastatic setting who previously received trastuzumab and a taxane, separately or in combination. |
Malignant Salivary Gland Neoplasm -
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Biomarker Criteria:
Sample must match one or more of the following:
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Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Metastatic (NCCN) | |
| Note: NCCN recommended for HER2-positive salivary gland tumors (recurrent, unresectable, metastatic). |
Fam-Trastuzumab Deruxtecan +
Adenocarcinoma of the Gastroesophageal Junction -
Breast Carcinoma -
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Biomarker Criteria:
Sample must match one or more of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Metastatic (FDA, NCCN) | |
| Note: Approved for patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting |
Colorectal Carcinoma -
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Biomarker Criteria:
Sample must match all of the following:
Sample must match one or more of the following: Sample must not match any of the following: BRAF V600E, BRAF V600_K601delinsE, KRAS A11_G12dup, KRAS A146S, KRAS A59E, KRAS A59G, KRAS A59P, KRAS A59S, KRAS A59T, KRAS A59V, KRAS Amplification, KRAS D119N, KRAS D33E, KRAS F156L, KRAS F28L, KRAS G10dup, KRAS G12F, KRAS G12L, KRAS G13E, KRAS G60R, KRAS K147E, KRAS K5N, KRAS L19F, KRAS N116S, KRAS P34L, KRAS P34R, KRAS Q22E, KRAS Q22K, KRAS Q22R, KRAS Q61E, KRAS T58I, KRAS T74P, KRAS V14I, KRAS V14L, KRAS Y71H, NRAS A59D, NRAS A59G, NRAS A59P, NRAS A59S, NRAS A59T, NRAS A59V, NRAS G60E |
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Metastatic (NCCN) | |
| Note: NCCN recommended as subsequent line therapy. |
Esophageal Carcinoma -
|
Biomarker Criteria:
Sample must match one or more of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Metastatic (NCCN) | |
| Note: Recommended as subsequent line therapy for patients with HER2-positive disease. |
Gastric Adenocarcinoma -
Lapatinib +
Breast Carcinoma -
Margetuximab +
Breast Carcinoma -
|
Biomarker Criteria:
Sample must match one or more of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Metastatic (FDA, NCCN) | |
| Note: Indicated in combination with chemotherapy for metastatic HER2-positive breast cancer that received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. |
Neratinib +
Breast Carcinoma -
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Biomarker Criteria:
Sample must match all of the following:
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Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Adjuvant (FDA, NCCN), Metastatic (FDA, NCCN) | |
| Note: Indicated for HER2-positive breast cancer, both in combination with capecitabine for advanced or metastatic disease with two or more prior anti-HER2 based regimens in the metastatic setting, and as a single agent for extended adjuvant treatment following adjuvant trastuzumab-based therapy. |
Pertuzumab +
Pertuzumab/trastuzumab/hyaluronidase +
Breast Carcinoma -
|
Biomarker Criteria:
Sample must match one or more of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Adjuvant (FDA, NCCN), Metastatic (FDA, NCCN) | |
| Note: Indicated for HER2+ breast cancer, for adjuvant treatment or for metastatic disease. Per NCCN, pertuzumab/trastuzumab/hyaluronidase injection for subcutaneous use may be substituted for trastuzumab + pertuzumab in any regimen. |
Trastuzumab +
Adenocarcinoma of the Gastroesophageal Junction -
Breast Carcinoma -
|
Biomarker Criteria:
Sample must match all of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Adjuvant (FDA, NCCN), Metastatic (FDA, NCCN) | |
| Note: Indicated for HER2-overexpressing breast cancer: (1) for metastatic disease with paclitaxel as first-line treatment, and as a single agent after one or more chemotherapy regimens. NCCN recommended with various chemotherapy combinations. (2) for adjuvant treatment with chemotherapy and as a single agent following multi-modality anthracycline based therapy. (3) Also NCCN recommended for neoadjuvant treatment. |
Endometrial Adenocarcinoma -
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Biomarker Criteria:
Sample must match one or more of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Metastatic (NCCN) | |
| Note: Recommended in combination with carboplatin and paclitaxel for stage III/IV or recurrent, HER2-positive uterine serous carcinoma. |
Gastric Carcinoma -
Malignant Esophageal Neoplasm -
Malignant Salivary Gland Neoplasm -
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Biomarker Criteria:
Sample must match one or more of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Metastatic (NCCN) | |
| Note: NCCN recommended as a single agent or in combination with docetaxel for HER2-positive salivary gland tumors (recurrent, unresectable, metastatic). |
Trastuzumab/hyaluronidase +
Breast Carcinoma -
|
Biomarker Criteria:
Sample must match all of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Adjuvant (FDA, NCCN), Metastatic (FDA, NCCN) | |
| Note: Indicated for HER2+ breast cancer, for adjuvant treatment or for metastatic disease. Per NCCN, trastuzumab/hyaluronidase injection for subcutaneous use may be substituted for trastuzumab in any regimen. |
Ado-Trastuzumab Emtansine + Endocrine Therapy +
Breast Carcinoma -
|
Biomarker Criteria:
Sample must match one or more of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Adjuvant (NCCN) | |
| Note: Recommended for adjuvant treatment of HR-positive, HER2-positive breast cancer. |
Aromatase Inhibitor + Lapatinib +
Breast Carcinoma -
|
Biomarker Criteria:
Sample must match one or more of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Metastatic (FDA, NCCN) | |
| Note: FDA approved with letrozole as the aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. NCCN recommended for any aromatase inhibitor. |
Aromatase Inhibitor + Lapatinib + Trastuzumab +
Breast Carcinoma -
|
Biomarker Criteria:
Sample must match one or more of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Metastatic (NCCN) | |
| Note: Recommended for HR-positve/HER2-positive recurrent or metastastic breast cancer. |
Aromatase Inhibitor + Trastuzumab +
Breast Carcinoma -
|
Biomarker Criteria:
Sample must match all of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Metastatic (SMC) |
|
Biomarker Criteria:
Sample must match all of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Metastatic (SMC) |
Capecitabine + Cisplatin + Trastuzumab +
Adenocarcinoma of the Gastroesophageal Junction -
Capecitabine + Lapatinib +
Breast Carcinoma -
|
Biomarker Criteria:
Sample must match all of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Metastatic (FDA, NCCN) | |
| Note: Indicated for advanced or metastatic breast cancer that overexpresses HER2 and that had prior therapy including an anthracycline, a taxane, and trastuzumab. |
Capecitabine + Trastuzumab + Tucatinib +
Breast Carcinoma -
|
Biomarker Criteria:
Sample must match one or more of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Metastatic (FDA, NCCN) | |
| Note: Indicated for patients with advanced HER2-positive breast cancer that is unresectable or metastatic, who have received one or more prior treatments. |
Carboplatin + Docetaxel + Trastuzumab +
Cisplatin + Fluorouracil + Trastuzumab +
Adenocarcinoma of the Gastroesophageal Junction -
Docetaxel + Trastuzumab +
Endocrine Therapy + Pertuzumab + Trastuzumab +
Breast Carcinoma -
|
Biomarker Criteria:
Sample must match one or more of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Adjuvant (NCCN) | |
| Note: Recommended for adjuvant treatment of HR-positive, HER2-positive breast cancer, with or without chemotherapy. |
Endocrine Therapy + Trastuzumab +
Breast Carcinoma -
|
Biomarker Criteria:
Sample must match one or more of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Adjuvant (NCCN), Metastatic (NCCN) | |
| Note: Recommend for HR-positive/HER2-positive breast cancer, with fulvestrant, tamoxifen, or aromatase inhibitor metastastic disease, or with tamoxifen or aromatase inhibitor for adjuvant treatment. |
Lapatinib + Trastuzumab +
Breast Carcinoma -
|
Biomarker Criteria:
Sample must match all of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Metastatic (NCCN) | |
| Note: Recommened for recurrent or metastatic HER2-positive breast cancer, without cytotoxic therapy. |
Colorectal Carcinoma -
|
Biomarker Criteria:
Sample must match all of the following:
Sample must match one or more of the following: Sample must not match any of the following: BRAF V600E, BRAF V600_K601delinsE, KRAS A11_G12dup, KRAS A146S, KRAS A59E, KRAS A59G, KRAS A59P, KRAS A59S, KRAS A59T, KRAS A59V, KRAS Amplification, KRAS D119N, KRAS D33E, KRAS F156L, KRAS F28L, KRAS G10dup, KRAS G12F, KRAS G12L, KRAS G13E, KRAS G60R, KRAS K147E, KRAS K5N, KRAS L19F, KRAS N116S, KRAS P34L, KRAS P34R, KRAS Q22E, KRAS Q22K, KRAS Q22R, KRAS Q61E, KRAS T58I, KRAS T74P, KRAS V14I, KRAS V14L, KRAS Y71H, NRAS A59D, NRAS A59G, NRAS A59P, NRAS A59S, NRAS A59T, NRAS A59V, NRAS G60E |
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Metastatic (NCCN) | |
| Note: NCCN recommended as subsequent line therapy. |
Paclitaxel + Pertuzumab + Trastuzumab +
Paclitaxel + Trastuzumab +
Pembrolizumab + Trastuzumab +
Adenocarcinoma of the Gastroesophageal Junction -
|
Biomarker Criteria:
Sample must match one or more of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Metastatic (FDA) | |
| Note: Indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced, unresectable, or metastatic HER2+ gastric or GEJ adenocarcinoma. |
Gastric Adenocarcinoma -
|
Biomarker Criteria:
Sample must match one or more of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Metastatic (FDA) | |
| Note: Indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced, unresectable, or metastatic HER2+ gastric or GEJ adenocarcinoma. |
Pertuzumab + Trastuzumab +
Breast Carcinoma -
|
Biomarker Criteria:
Sample must match all of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Adjuvant (FDA, NCCN), Metastatic (FDA, NCCN) | |
| Note: FDA approved for HER2-positive breast cancer, for metastatic disease with paclitaxel for with no prior anti-HER2 therapy or chemotherapy in that setting, and for adjuvant and neoadjuvant treatment in combination with chemotherapy. Per NCCN, other chemotherapy combinations, or no chemotherapy combination, are options for these settings. |
Colorectal Carcinoma -
|
Biomarker Criteria:
Sample must match all of the following:
Sample must match one or more of the following: Sample must not match any of the following: BRAF V600E, BRAF V600_K601delinsE, KRAS A11_G12dup, KRAS A146S, KRAS A59E, KRAS A59G, KRAS A59P, KRAS A59S, KRAS A59T, KRAS A59V, KRAS Amplification, KRAS D119N, KRAS D33E, KRAS F156L, KRAS F28L, KRAS G10dup, KRAS G12F, KRAS G12L, KRAS G13E, KRAS G60R, KRAS K147E, KRAS K5N, KRAS L19F, KRAS N116S, KRAS P34L, KRAS P34R, KRAS Q22E, KRAS Q22K, KRAS Q22R, KRAS Q61E, KRAS T58I, KRAS T74P, KRAS V14I, KRAS V14L, KRAS Y71H, NRAS A59D, NRAS A59G, NRAS A59P, NRAS A59S, NRAS A59T, NRAS A59V, NRAS G60E |
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Metastatic (NCCN) | |
| Note: NCCN recommended as subsequent line therapy. |
Malignant Salivary Gland Neoplasm -
|
Biomarker Criteria:
Sample must match one or more of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Metastatic (NCCN) | |
| Note: NCCN recommended for HER2-positive salivary gland tumors (recurrent, unresectable, metastatic). |
Clinical Trials
HER2 Positive serves as an inclusion eligibility criterion in 385 clinical trials, of which 271 are open and 114 are closed. Of the trials that contain HER2 Positive as an inclusion criterion, 5 are early phase 1 (3 open), 107 are phase 1 (69 open), 57 are phase 1/phase 2 (36 open), 151 are phase 2 (111 open), 6 are phase 2/phase 3 (3 open), 51 are phase 3 (41 open), and 8 are no phase specified (8 open).
Trials with HER2 Positive in the inclusion eligibility criteria most commonly target breast carcinoma, malignant solid tumor, adenocarcinoma of the gastroesophageal junction, gastric adenocarcinoma, and gastric carcinoma [5].
Trastuzumab, pertuzumab, paclitaxel, ado-trastuzumab emtansine, and capecitabine are the most frequent therapies in trials with HER2 Positive as an inclusion criteria [5].
Significance of HER2 Positive in Diseases
Breast Carcinoma -
HER2 Positive is an inclusion criterion in 259 clinical trials for breast carcinoma, of which 171 are open and 88 are closed. Of the trials that contain HER2 Positive and breast carcinoma as inclusion criteria, 2 are early phase 1 (1 open), 67 are phase 1 (36 open), 42 are phase 1/phase 2 (29 open), 102 are phase 2 (69 open), 2 are phase 2/phase 3 (0 open), 37 are phase 3 (29 open), and 7 are no phase specified (7 open) [5].
Ado-trastuzumab emtansine, trastuzumab, aromatase inhibitor, lapatinib, pertuzumab/trastuzumab/hyaluronidase, pertuzumab, paclitaxel, neratinib, margetuximab, fam-trastuzumab deruxtecan, endocrine therapy, docetaxel, carboplatin, capecitabine, tucatinib, and trastuzumab/hyaluronidase have evidence of efficacy in patients with HER2 Positive in breast carcinoma [5].
Adenocarcinoma Of The Gastroesophageal Junction +
HER2 Positive is an inclusion criterion in 39 clinical trials for adenocarcinoma of the gastroesophageal junction, of which 30 are open and 9 are closed. Of the trials that contain HER2 Positive and adenocarcinoma of the gastroesophageal junction as inclusion criteria, 8 are phase 1 (6 open), 7 are phase 1/phase 2 (5 open), 15 are phase 2 (13 open), 4 are phase 2/phase 3 (3 open), and 5 are phase 3 (3 open) [5].
Capecitabine, cisplatin, trastuzumab, fluorouracil, fam-trastuzumab deruxtecan, and pembrolizumab have evidence of efficacy in patients with HER2 Positive in adenocarcinoma of the gastroesophageal junction [5].
Gastric Adenocarcinoma +
HER2 Positive is an inclusion criterion in 31 clinical trials for gastric adenocarcinoma, of which 27 are open and 4 are closed. Of the trials that contain HER2 Positive and gastric adenocarcinoma as inclusion criteria, 6 are phase 1 (6 open), 4 are phase 1/phase 2 (3 open), 14 are phase 2 (12 open), 3 are phase 2/phase 3 (3 open), and 4 are phase 3 (3 open) [5].
Fam-trastuzumab deruxtecan, pembrolizumab, and trastuzumab have evidence of efficacy in patients with HER2 Positive in gastric adenocarcinoma [5].
Gastric Carcinoma +
HER2 Positive is an inclusion criterion in 24 clinical trials for gastric carcinoma, of which 9 are open and 15 are closed. Of the trials that contain HER2 Positive and gastric carcinoma as inclusion criteria, 12 are phase 1 (3 open), 5 are phase 1/phase 2 (4 open), 5 are phase 2 (2 open), 1 is phase 2/phase 3 (0 open), and 1 is phase 3 (0 open) [5].
Capecitabine, cisplatin, trastuzumab, and fluorouracil have evidence of efficacy in patients with HER2 Positive in gastric carcinoma [5].
Colorectal Carcinoma +
HER2 Positive is an inclusion criterion in 14 clinical trials for colorectal carcinoma, of which 10 are open and 4 are closed. Of the trials that contain HER2 Positive and colorectal carcinoma as inclusion criteria, 5 are phase 1 (3 open), 4 are phase 1/phase 2 (3 open), and 5 are phase 2 (4 open) [5].
Fam-trastuzumab deruxtecan, lapatinib, trastuzumab, and pertuzumab have evidence of efficacy in patients with HER2 Positive in colorectal carcinoma [5].
Esophageal Carcinoma +
HER2 Positive is an inclusion criterion in 6 clinical trials for esophageal carcinoma, of which 3 are open and 3 are closed. Of the trials that contain HER2 Positive and esophageal carcinoma as inclusion criteria, 2 are phase 1 (0 open), 3 are phase 2 (2 open), and 1 is phase 3 (1 open) [5].
Fam-trastuzumab deruxtecan has evidence of efficacy in patients with HER2 Positive in esophageal carcinoma [5].
Malignant Salivary Gland Neoplasm +
HER2 Positive is an inclusion criterion in 1 clinical trial for malignant salivary gland neoplasm, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and malignant salivary gland neoplasm as inclusion criteria, 1 is phase 2 (1 open) [5].
Ado-trastuzumab emtansine, pertuzumab, and trastuzumab have evidence of efficacy in patients with HER2 Positive in malignant salivary gland neoplasm [5].
Endometrial Adenocarcinoma +
Trastuzumab has evidence of efficacy in patients with HER2 Positive in endometrial adenocarcinoma [5].
Malignant Esophageal Neoplasm +
Trastuzumab has evidence of efficacy in patients with HER2 Positive in malignant esophageal neoplasm [5].
Malignant Solid Tumor +
HER2 Positive is an inclusion criterion in 65 clinical trials for malignant solid tumor, of which 44 are open and 21 are closed. Of the trials that contain HER2 Positive and malignant solid tumor as inclusion criteria, 45 are phase 1 (32 open), 14 are phase 1/phase 2 (7 open), and 6 are phase 2 (5 open) [5].
Invasive Breast Carcinoma +
HER2 Positive is an inclusion criterion in 15 clinical trials for invasive breast carcinoma, of which 14 are open and 1 is closed. Of the trials that contain HER2 Positive and invasive breast carcinoma as inclusion criteria, 1 is early phase 1 (1 open), 1 is phase 1 (1 open), 1 is phase 1/phase 2 (0 open), 5 are phase 2 (5 open), and 7 are phase 3 (7 open) [5].
Non-Small Cell Lung Carcinoma +
HER2 Positive is an inclusion criterion in 15 clinical trials for non-small cell lung carcinoma, of which 7 are open and 8 are closed. Of the trials that contain HER2 Positive and non-small cell lung carcinoma as inclusion criteria, 7 are phase 1 (3 open), 3 are phase 1/phase 2 (1 open), and 5 are phase 2 (3 open) [5].
Endometrial Carcinoma +
HER2 Positive is an inclusion criterion in 10 clinical trials for endometrial carcinoma, of which 9 are open and 1 is closed. Of the trials that contain HER2 Positive and endometrial carcinoma as inclusion criteria, 2 are phase 1 (2 open), 3 are phase 1/phase 2 (2 open), and 5 are phase 2 (5 open) [5].
Esophageal Adenocarcinoma +
HER2 Positive is an inclusion criterion in 10 clinical trials for esophageal adenocarcinoma, of which 10 are open and 0 are closed. Of the trials that contain HER2 Positive and esophageal adenocarcinoma as inclusion criteria, 3 are phase 1 (3 open), 1 is phase 1/phase 2 (1 open), and 6 are phase 2 (6 open) [5].
Breast Adenocarcinoma +
HER2 Positive is an inclusion criterion in 9 clinical trials for breast adenocarcinoma, of which 8 are open and 1 is closed. Of the trials that contain HER2 Positive and breast adenocarcinoma as inclusion criteria, 1 is phase 1 (1 open), 6 are phase 2 (5 open), and 2 are phase 3 (2 open) [5].
Ovarian Carcinoma +
HER2 Positive is an inclusion criterion in 6 clinical trials for ovarian carcinoma, of which 4 are open and 2 are closed. Of the trials that contain HER2 Positive and ovarian carcinoma as inclusion criteria, 4 are phase 1 (2 open), 1 is phase 1/phase 2 (1 open), and 1 is phase 2 (1 open) [5].
Urothelial Carcinoma +
HER2 Positive is an inclusion criterion in 6 clinical trials for urothelial carcinoma, of which 5 are open and 1 is closed. Of the trials that contain HER2 Positive and urothelial carcinoma as inclusion criteria, 2 are phase 1 (1 open), 2 are phase 1/phase 2 (2 open), and 2 are phase 2 (2 open) [5].
Ductal Carcinoma In Situ +
HER2 Positive is an inclusion criterion in 5 clinical trials for ductal carcinoma in situ, of which 3 are open and 2 are closed. Of the trials that contain HER2 Positive and ductal carcinoma in situ as inclusion criteria, 1 is early phase 1 (1 open), 1 is phase 1 (1 open), and 3 are phase 1/phase 2 (1 open) [5].
Head And Neck Squamous Cell Carcinoma +
HER2 Positive is an inclusion criterion in 5 clinical trials for head and neck squamous cell carcinoma, of which 2 are open and 3 are closed. Of the trials that contain HER2 Positive and head and neck squamous cell carcinoma as inclusion criteria, 3 are phase 1 (2 open), 1 is phase 1/phase 2 (0 open), and 1 is phase 2 (0 open) [5].
Inflammatory Breast Carcinoma +
HER2 Positive is an inclusion criterion in 5 clinical trials for inflammatory breast carcinoma, of which 4 are open and 1 is closed. Of the trials that contain HER2 Positive and inflammatory breast carcinoma as inclusion criteria, 1 is phase 1/phase 2 (1 open), 3 are phase 2 (2 open), and 1 is phase 3 (1 open) [5].
Melanoma +
HER2 Positive is an inclusion criterion in 5 clinical trials for melanoma, of which 2 are open and 3 are closed. Of the trials that contain HER2 Positive and melanoma as inclusion criteria, 2 are phase 1 (1 open) and 3 are phase 2 (1 open) [5].
Pancreatic Carcinoma +
HER2 Positive is an inclusion criterion in 5 clinical trials for pancreatic carcinoma, of which 4 are open and 1 is closed. Of the trials that contain HER2 Positive and pancreatic carcinoma as inclusion criteria, 1 is phase 1 (1 open), 1 is phase 1/phase 2 (0 open), and 3 are phase 2 (3 open) [5].
Biliary Tract Carcinoma +
HER2 Positive is an inclusion criterion in 4 clinical trials for biliary tract carcinoma, of which 4 are open and 0 are closed. Of the trials that contain HER2 Positive and biliary tract carcinoma as inclusion criteria, 1 is phase 1/phase 2 (1 open) and 3 are phase 2 (3 open) [5].
Cervical Carcinoma +
HER2 Positive is an inclusion criterion in 4 clinical trials for cervical carcinoma, of which 3 are open and 1 is closed. Of the trials that contain HER2 Positive and cervical carcinoma as inclusion criteria, 1 is phase 1 (0 open) and 3 are phase 2 (3 open) [5].
Gallbladder Carcinoma +
HER2 Positive is an inclusion criterion in 4 clinical trials for gallbladder carcinoma, of which 4 are open and 0 are closed. Of the trials that contain HER2 Positive and gallbladder carcinoma as inclusion criteria, 1 is phase 1/phase 2 (1 open) and 3 are phase 2 (3 open) [5].
Non-Squamous Non-Small Cell Lung Carcinoma +
HER2 Positive is an inclusion criterion in 4 clinical trials for non-squamous non-small cell lung carcinoma, of which 4 are open and 0 are closed. Of the trials that contain HER2 Positive and non-squamous non-small cell lung carcinoma as inclusion criteria, 1 is phase 1 (1 open) and 3 are phase 2 (3 open) [5].
Bile Duct Carcinoma +
HER2 Positive is an inclusion criterion in 3 clinical trials for bile duct carcinoma, of which 2 are open and 1 is closed. Of the trials that contain HER2 Positive and bile duct carcinoma as inclusion criteria, 3 are phase 2 (2 open) [5].
Bladder Carcinoma +
HER2 Positive is an inclusion criterion in 3 clinical trials for bladder carcinoma, of which 2 are open and 1 is closed. Of the trials that contain HER2 Positive and bladder carcinoma as inclusion criteria, 1 is phase 1 (0 open) and 2 are phase 2 (2 open) [5].
Cancer +
HER2 Positive is an inclusion criterion in 3 clinical trials for cancer, of which 2 are open and 1 is closed. Of the trials that contain HER2 Positive and cancer as inclusion criteria, 1 is early phase 1 (0 open), 1 is phase 1 (1 open), and 1 is phase 1/phase 2 (1 open) [5].
Colorectal Adenocarcinoma +
HER2 Positive is an inclusion criterion in 3 clinical trials for colorectal adenocarcinoma, of which 2 are open and 1 is closed. Of the trials that contain HER2 Positive and colorectal adenocarcinoma as inclusion criteria, 3 are phase 2 (2 open) [5].
Hepatocellular Carcinoma +
HER2 Positive is an inclusion criterion in 3 clinical trials for hepatocellular carcinoma, of which 3 are open and 0 are closed. Of the trials that contain HER2 Positive and hepatocellular carcinoma as inclusion criteria, 1 is phase 1 (1 open), 1 is phase 1/phase 2 (1 open), and 1 is phase 2 (1 open) [5].
Prostate Carcinoma +
HER2 Positive is an inclusion criterion in 3 clinical trials for prostate carcinoma, of which 2 are open and 1 is closed. Of the trials that contain HER2 Positive and prostate carcinoma as inclusion criteria, 2 are phase 1 (1 open) and 1 is phase 2 (1 open) [5].
Cholangiocarcinoma +
HER2 Positive is an inclusion criterion in 2 clinical trials for cholangiocarcinoma, of which 2 are open and 0 are closed. Of the trials that contain HER2 Positive and cholangiocarcinoma as inclusion criteria, 1 is phase 1/phase 2 (1 open) and 1 is phase 2 (1 open) [5].
Esophageal Squamous Cell Carcinoma +
HER2 Positive is an inclusion criterion in 2 clinical trials for esophageal squamous cell carcinoma, of which 2 are open and 0 are closed. Of the trials that contain HER2 Positive and esophageal squamous cell carcinoma as inclusion criteria, 2 are phase 2 (2 open) [5].
Head And Neck Carcinoma +
HER2 Positive is an inclusion criterion in 2 clinical trials for head and neck carcinoma, of which 1 is open and 1 is closed. Of the trials that contain HER2 Positive and head and neck carcinoma as inclusion criteria, 1 is phase 1 (0 open) and 1 is phase 2 (1 open) [5].
Leukemia +
HER2 Positive is an inclusion criterion in 2 clinical trials for leukemia, of which 1 is open and 1 is closed. Of the trials that contain HER2 Positive and leukemia as inclusion criteria, 2 are phase 1 (1 open) [5].
Lung Adenocarcinoma +
HER2 Positive is an inclusion criterion in 2 clinical trials for lung adenocarcinoma, of which 2 are open and 0 are closed. Of the trials that contain HER2 Positive and lung adenocarcinoma as inclusion criteria, 1 is phase 1 (1 open) and 1 is phase 2 (1 open) [5].
Lung Carcinoma +
HER2 Positive is an inclusion criterion in 2 clinical trials for lung carcinoma, of which 1 is open and 1 is closed. Of the trials that contain HER2 Positive and lung carcinoma as inclusion criteria, 2 are phase 2 (1 open) [5].
Lymphoma +
HER2 Positive is an inclusion criterion in 2 clinical trials for lymphoma, of which 1 is open and 1 is closed. Of the trials that contain HER2 Positive and lymphoma as inclusion criteria, 1 is phase 1 (0 open) and 1 is phase 1/phase 2 (1 open) [5].
Malignant Uterine Neoplasm +
HER2 Positive is an inclusion criterion in 2 clinical trials for malignant uterine neoplasm, of which 2 are open and 0 are closed. Of the trials that contain HER2 Positive and malignant uterine neoplasm as inclusion criteria, 2 are phase 2 (2 open) [5].
Renal Cell Carcinoma +
HER2 Positive is an inclusion criterion in 2 clinical trials for renal cell carcinoma, of which 1 is open and 1 is closed. Of the trials that contain HER2 Positive and renal cell carcinoma as inclusion criteria, 2 are phase 1 (1 open) [5].
Sarcoma +
HER2 Positive is an inclusion criterion in 2 clinical trials for sarcoma, of which 2 are open and 0 are closed. Of the trials that contain HER2 Positive and sarcoma as inclusion criteria, 2 are phase 1 (2 open) [5].
Ampulla Of Vater Carcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for ampulla of vater carcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and ampulla of vater carcinoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Biliary Tract Neoplasm +
HER2 Positive is an inclusion criterion in 1 clinical trial for biliary tract neoplasm, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and biliary tract neoplasm as inclusion criteria, 1 is phase 1/phase 2 (1 open) [5].
Breast Invasive Ductal Carcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for breast invasive ductal carcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and breast invasive ductal carcinoma as inclusion criteria, 1 is no phase specified (1 open) [5].
Bronchogenic Carcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for bronchogenic carcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and bronchogenic carcinoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Carcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for carcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and carcinoma as inclusion criteria, 1 is phase 1 (1 open) [5].
Central Nervous System Neoplasm +
HER2 Positive is an inclusion criterion in 1 clinical trial for central nervous system neoplasm, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and central nervous system neoplasm as inclusion criteria, 1 is phase 1 (1 open) [5].
Digestive System Carcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for digestive system carcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and digestive system carcinoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Endometrial Serous Adenocarcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for endometrial serous adenocarcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and endometrial serous adenocarcinoma as inclusion criteria, 1 is phase 1 (1 open) [5].
Ependymoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for ependymoma, of which 0 are open and 1 is closed. Of the trial that contains HER2 Positive and ependymoma as inclusion criteria, 1 is phase 1/phase 2 (0 open) [5].
Extrahepatic Cholangiocarcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for extrahepatic cholangiocarcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and extrahepatic cholangiocarcinoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Germ Cell Tumor +
HER2 Positive is an inclusion criterion in 1 clinical trial for germ cell tumor, of which 0 are open and 1 is closed. Of the trial that contains HER2 Positive and germ cell tumor as inclusion criteria, 1 is phase 2 (0 open) [5].
Glioblastoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for glioblastoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and glioblastoma as inclusion criteria, 1 is phase 1 (1 open) [5].
Glioma +
HER2 Positive is an inclusion criterion in 1 clinical trial for glioma, of which 0 are open and 1 is closed. Of the trial that contains HER2 Positive and glioma as inclusion criteria, 1 is phase 1/phase 2 (0 open) [5].
Gliosarcoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for gliosarcoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and gliosarcoma as inclusion criteria, 1 is phase 1 (1 open) [5].
Hypopharyngeal Squamous Cell Carcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for hypopharyngeal squamous cell carcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and hypopharyngeal squamous cell carcinoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Intrahepatic Cholangiocarcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for intrahepatic cholangiocarcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and intrahepatic cholangiocarcinoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Laryngeal Squamous Cell Carcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for laryngeal squamous cell carcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and laryngeal squamous cell carcinoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Liposarcoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for liposarcoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and liposarcoma as inclusion criteria, 1 is phase 1 (1 open) [5].
Low Grade Glioma +
HER2 Positive is an inclusion criterion in 1 clinical trial for low grade glioma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and low grade glioma as inclusion criteria, 1 is phase 1 (1 open) [5].
Malignant Bone Marrow Neoplasm +
HER2 Positive is an inclusion criterion in 1 clinical trial for malignant bone marrow neoplasm, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and malignant bone marrow neoplasm as inclusion criteria, 1 is phase 1 (1 open) [5].
Malignant Central Nervous System Neoplasm +
HER2 Positive is an inclusion criterion in 1 clinical trial for malignant central nervous system neoplasm, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and malignant central nervous system neoplasm as inclusion criteria, 1 is phase 1 (1 open) [5].
Malignant Colorectal Neoplasm +
HER2 Positive is an inclusion criterion in 1 clinical trial for malignant colorectal neoplasm, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and malignant colorectal neoplasm as inclusion criteria, 1 is phase 1 (1 open) [5].
Malignant Digestive System Neoplasm +
HER2 Positive is an inclusion criterion in 1 clinical trial for malignant digestive system neoplasm, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and malignant digestive system neoplasm as inclusion criteria, 1 is phase 1 (1 open) [5].
Malignant Endometrial Neoplasm +
HER2 Positive is an inclusion criterion in 1 clinical trial for malignant endometrial neoplasm, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and malignant endometrial neoplasm as inclusion criteria, 1 is phase 1 (1 open) [5].
Malignant Glioma +
HER2 Positive is an inclusion criterion in 1 clinical trial for malignant glioma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and malignant glioma as inclusion criteria, 1 is phase 1 (1 open) [5].
Malignant Ovarian Epithelial Tumor +
HER2 Positive is an inclusion criterion in 1 clinical trial for malignant ovarian epithelial tumor, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and malignant ovarian epithelial tumor as inclusion criteria, 1 is phase 2 (1 open) [5].
Malignant Ovarian Neoplasm +
HER2 Positive is an inclusion criterion in 1 clinical trial for malignant ovarian neoplasm, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and malignant ovarian neoplasm as inclusion criteria, 1 is phase 1 (1 open) [5].
Malignant Urethral Neoplasm +
HER2 Positive is an inclusion criterion in 1 clinical trial for malignant urethral neoplasm, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and malignant urethral neoplasm as inclusion criteria, 1 is phase 1 (1 open) [5].
Medulloblastoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for medulloblastoma, of which 0 are open and 1 is closed. Of the trial that contains HER2 Positive and medulloblastoma as inclusion criteria, 1 is phase 1/phase 2 (0 open) [5].
Metastatic Malignant Neoplasm In The Brain +
HER2 Positive is an inclusion criterion in 1 clinical trial for metastatic malignant neoplasm in the brain, of which 0 are open and 1 is closed. Of the trial that contains HER2 Positive and metastatic malignant neoplasm in the brain as inclusion criteria, 1 is phase 2 (0 open) [5].
Oral Cavity Squamous Cell Carcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for oral cavity squamous cell carcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and oral cavity squamous cell carcinoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Oropharyngeal Squamous Cell Carcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for oropharyngeal squamous cell carcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and oropharyngeal squamous cell carcinoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Osteosarcoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for osteosarcoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and osteosarcoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Prostate Adenocarcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for prostate adenocarcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and prostate adenocarcinoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Salivary Carcinoma, NOS +
HER2 Positive is an inclusion criterion in 1 clinical trial for salivary carcinoma, NOS, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and salivary carcinoma, NOS as inclusion criteria, 1 is phase 2 (1 open) [5].
Salivary Duct Carcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for salivary duct carcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and salivary duct carcinoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Salivary Gland Acinic Cell Carcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for salivary gland acinic cell carcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and salivary gland acinic cell carcinoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Salivary Gland Adenocarcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for salivary gland adenocarcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and salivary gland adenocarcinoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Salivary Gland Carcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for salivary gland carcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and salivary gland carcinoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Salivary Gland Carcinoma Ex Pleomorphic Adenoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for salivary gland carcinoma ex pleomorphic adenoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and salivary gland carcinoma ex pleomorphic adenoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Salivary Gland Mucoepidermoid Carcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for salivary gland mucoepidermoid carcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and salivary gland mucoepidermoid carcinoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Salivary Gland Small Cell Carcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for salivary gland small cell carcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and salivary gland small cell carcinoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Salivary Gland Squamous Cell Carcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for salivary gland squamous cell carcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and salivary gland squamous cell carcinoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Small Cell Lung Carcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for small cell lung carcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and small cell lung carcinoma as inclusion criteria, 1 is phase 1 (1 open) [5].
Small Intestinal Carcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for small intestinal carcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and small intestinal carcinoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Soft Tissue Sarcoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for soft tissue sarcoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and soft tissue sarcoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Squamous Cell Lung Carcinoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for squamous cell lung carcinoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and squamous cell lung carcinoma as inclusion criteria, 1 is phase 2 (1 open) [5].
Uterine Carcinosarcoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for uterine carcinosarcoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and uterine carcinosarcoma as inclusion criteria, 1 is phase 1 (1 open) [5].
Uterine Corpus Carcinosarcoma +
HER2 Positive is an inclusion criterion in 1 clinical trial for uterine corpus carcinosarcoma, of which 1 is open and 0 are closed. Of the trial that contains HER2 Positive and uterine corpus carcinosarcoma as inclusion criteria, 1 is phase 2 (1 open) [5].
References
1. Hart R and Prlic A. Universal Transcript Archive Repository. Version uta_20180821. San Francisco CA: Github;2015. https://github.com/biocommons/uta
2. The UniProt Consortium. UniProt: a worldwide hub of protein knowledge. Nucleic Acids Research. 2019;47:D506-D515.
3. Liu X, Wu C, Li C, and Boerwinkle E. dbNSFP v3.0: A one-stop database of functional predictions and annotations for human nonsynonymous and splice site SNVs. Human Mutation. 2015;37:235-241.
Liu X, Jian X, and Boerwinkle E. dbNSFP: A lightweight database of human nonsynonymous SNPs and their functional predictions. Human Mutation. 2011;32:894-899.
4. The AACR Project GENIE Consortium. AACR Project GENIE: powering precision medicine through an international consortium. Cancer Discovery. 2017;7(8):818-831. Dataset Version 8. This dataset does not represent the totality of the genetic landscape; see paper for more information.
5. All assertions and clinical trial landscape data are curated from primary sources. You can read more about the curation process here.
