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BIOMARKER:

HER-2 amplification

i
Entrez ID:
Related tests:
Phase 2/3
National Cancer Institute (NCI)
Recruiting
Last update posted :
02/24/2025
Initiation :
11/16/2022
Primary completion :
10/31/2027
Completion :
10/31/2027
HER-2 • TP53
|
HER-2 positive • HER-2 amplification
|
Herceptin (trastuzumab) • carboplatin • paclitaxel • Perjeta (pertuzumab) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
Phase 1
Fred Hutchinson Cancer Center
Active, not recruiting
Last update posted :
02/21/2025
Initiation :
12/15/2023
Primary completion :
12/31/2025
Completion :
02/09/2026
HER-2 • KRAS • BRAF • ALK • TMB • MSI • NTRK
|
KRAS mutation • TMB-H • BRAF mutation • HER-2 amplification • ROS1 fusion • KRAS G12 • NTRK fusion
|
cyclophosphamide • bendamustine • fludarabine IV
Phase 1
National Cancer Institute (NCI)
Suspended
Last update posted :
02/21/2025
Initiation :
08/02/2022
Primary completion :
03/14/2025
Completion :
03/14/2025
HER-2 • KRAS • BRAF • ER • PGR • NRAS • HRAS • NF1
|
BRAF mutation • HER-2 amplification • HRAS mutation • BRAF fusion
|
Mektovi (binimetinib) • ZEN-3694
Phase 2
ImmunityBio, Inc.
Withdrawn
Last update posted :
02/21/2025
Initiation :
09/01/2018
Primary completion :
06/01/2020
Completion :
02/09/2022
HER-2 • ER • PGR
|
HER-2 overexpression • HER-2 amplification
|
5-fluorouracil • Bavencio (avelumab) • albumin-bound paclitaxel • cyclophosphamide • leucovorin calcium • Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-011 • ETBX-051 • ETBX-061 • GI-4000 • GI-6207 • GI-6301 • NK92-CD16-158V • aldoxorubicin (INNO-206)
Phase 1/2
National Cancer Institute (NCI)
Active, not recruiting
Last update posted :
02/21/2025
Initiation :
03/01/2021
Primary completion :
06/30/2025
Completion :
06/30/2025
ER • PIK3CA • PGR • PTEN
|
HER-2 amplification • HER-2 negative • PIK3CA mutation
|
Halaven (eribulin mesylate) • Aliqopa (copanlisib)
Phase 1
National Cancer Institute (NCI)
Recruiting
Last update posted :
02/19/2025
Initiation :
08/09/2021
Primary completion :
03/31/2026
Completion :
03/31/2026
HER-2 • TP53 • ATM • RAS • CD4
|
HER-2 positive • TP53 mutation • HER-2 amplification • HER-2 expression • RAS mutation
|
Enhertu (fam-trastuzumab deruxtecan-nxki) • ceralasertib (AZD6738)
Phase 2
Dana-Farber Cancer Institute
Recruiting
Last update posted :
02/18/2025
Initiation :
12/24/2020
Primary completion :
02/01/2026
Completion :
02/01/2027
HER-2
|
HER-2 positive • HER-2 amplification • HER-2 expression
|
cisplatin • carboplatin • Kadcyla (ado-trastuzumab emtansine)
Phase 1/2
TiumBio Co., Ltd.
Recruiting
Last update posted :
02/17/2025
Initiation :
03/10/2023
Primary completion :
12/01/2026
Completion :
12/01/2028
EGFR • KRAS • BRAF • NRAS
|
BRAF V600E • HER-2 amplification • BRAF V600 • BRAF wild-type
|
Keytruda (pembrolizumab) • NCE 401
Phase 2
Gruppo Oncologico del Nord-Ovest
Recruiting
Last update posted :
02/17/2025
Initiation :
05/11/2023
Primary completion :
05/01/2026
Completion :
05/01/2028
HER-2 • KRAS • BRAF • TMB • MSI • POLE • POLD1
|
HER-2 positive • MSI-H/dMMR • KRAS G12C • HER-2 amplification • HER-2 mutation • POLE mutation • KRAS wild-type • RAS wild-type • KRAS G12 • POLD1 mutation • HER-2 positive + HER-2 overexpression • HER-2 positive + RAS wild-type
|
Imfinzi (durvalumab) • Vectibix (panitumumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Lumakras (sotorasib) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
Phase 3
Hoffmann-La Roche
Active, not recruiting
Last update posted :
02/17/2025
Initiation :
07/05/2022
Primary completion :
11/20/2024
Completion :
12/31/2025
HER-2
|
HER-2 amplification • EGFR positive
|
Herceptin (trastuzumab) • carboplatin • paclitaxel • docetaxel • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • doxorubicin hydrochloride • cyclophosphamide • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
Phase 2
Cancer Institute and Hospital, Chinese Academy ...
Recruiting
Last update posted :
02/11/2025
Initiation :
08/15/2020
Primary completion :
07/01/2026
Completion :
07/01/2028
EGFR • HER-2 • BRAF • ALK • MET • BRCA1 • BRCA2 • KIT • ROS1 • CDKN2A
|
BRCA2 mutation • BRCA1 mutation • EGFR mutation • HER-2 overexpression • BRAF mutation • HER-2 amplification • MET amplification • KIT mutation • ALK fusion • ROS1 fusion • CDKN2A mutation • MET mutation • BRAF amplification
|
Xalkori (crizotinib) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • Zelboraf (vemurafenib) • imatinib • Tyvyt (sintilimab) • Alecensa (alectinib) • Zejula (niraparib) • Irene (pyrotinib) • Ameile (aumolertinib) • Vizimpro (dacomitinib)
Phase 3
Sichuan Baili Pharmaceutical Co., Ltd.
Recruiting
Last update posted :
02/11/2025
Initiation :
07/14/2023
Primary completion :
07/01/2026
Completion :
07/01/2026
EGFR • HER-2 • KRAS • BRAF • ALK • ROS1 • NTRK
|
KRAS mutation • KRAS G12C • BRAF mutation • HER-2 amplification • BRAF V600 • KRAS G12D • EGFR wild-type • RET mutation • ALK wild-type • ROS1 fusion • ROS1 rearrangement • RET rearrangement • KRAS G12 • KRAS amplification • NTRK fusion
|
docetaxel • izalontamab (SI-B001)
Phase 1/2
H. Lee Moffitt Cancer Center and Research Insti...
Active, not recruiting
Last update posted :
02/10/2025
Initiation :
05/02/2017
Primary completion :
09/20/2020
Completion :
03/31/2025
HER-2 • ER • PGR
|
HER-2 amplification
|
paclitaxel • Imlygic (talimogene laherparepvec)
Phase 1
Boehringer Ingelheim
Completed
Last update posted :
02/10/2025
Initiation :
08/01/2009
Primary completion :
10/01/2013
Completion :
10/01/2013
HER-2
|
HER-2 amplification
|
Herceptin (trastuzumab) • Gilotrif (afatinib)
Phase 1
Boehringer Ingelheim
Recruiting
Last update posted :
02/10/2025
Initiation :
07/02/2021
Primary completion :
03/31/2026
Completion :
01/28/2028
NRG1
|
EGFR mutation • HER-2 overexpression • HER-2 amplification • HER-2 mutation
|
zongertinib (BI 1810631)
Phase 1
M.D. Anderson Cancer Center
Active, not recruiting
Last update posted :
02/10/2025
Initiation :
10/31/2017
Primary completion :
10/01/2025
Completion :
10/01/2025
HER-2 • KRAS • ERBB3 • ERBB4
|
KRAS mutation • EGFR mutation • HER-2 amplification • EGFR amplification
|
Mekinist (trametinib) • Ibrance (palbociclib) • everolimus • Nerlynx (neratinib)
Phase 1
University of Washington
Active, not recruiting
Last update posted :
02/06/2025
Initiation :
10/01/2001
Primary completion :
03/01/2010
Completion :
04/01/2025
HER-2 • MUC16
|
HER-2 overexpression • HER-2 amplification
|
AST-301 • Leukine (sargramostim)
Phase 1
City of Hope Medical Center
Recruiting
Last update posted :
02/06/2025
Initiation :
08/31/2018
Primary completion :
03/11/2025
Completion :
03/11/2025
HER-2
|
HER-2 amplification
|
MB-103
Phase 3
National Cancer Institute (NCI)
Active, not recruiting
Last update posted :
02/06/2025
Initiation :
12/01/2008
Primary completion :
01/31/2014
Completion :
07/10/2025
HER-2 • ER • PGR
|
HER-2 positive • HER-2 amplification
|
Herceptin (trastuzumab) • paclitaxel • lapatinib • Herzuma (trastuzumab-pkrb) • Ontruzant (trastuzumab-dttb) • Ogivri (trastuzumab-dkst) • Trazimera (trastuzumab-qyyp) • Herwenda (trastuzumab biosimilar) • GB221 (coprelotamab) • SIBP-01 (trastuzumab biosimilar)
Phase 1/2
Seagen Inc.
Active, not recruiting
Last update posted :
02/06/2025
Initiation :
09/15/2020
Primary completion :
07/31/2024
Completion :
10/31/2025
HER-2
|
HER-2 overexpression • HER-2 amplification
|
Keytruda (pembrolizumab) • Herceptin (trastuzumab) • 5-fluorouracil • capecitabine • oxaliplatin • Tukysa (tucatinib) • leucovorin calcium
Phase 2
Breast Cancer Trials, Australia and New Zealand
Recruiting
Last update posted :
02/05/2025
Initiation :
03/07/2023
Primary completion :
09/30/2025
Completion :
09/01/2026
HER-2 • PD-L1
|
PD-L1 expression • HER-2 positive • HER-2 amplification • HER-2 expression • PD-L1 negative
|
Keytruda (pembrolizumab) • Herceptin (trastuzumab) • capecitabine • Tukysa (tucatinib)
Phase 1
National Cancer Institute (NCI)
Active, not recruiting
Last update posted :
02/04/2025
Initiation :
06/17/2020
Primary completion :
06/22/2023
Completion :
07/16/2025
HER-2 • ER • PIK3CA • PGR • PTEN
|
HER-2 amplification • HER-2 negative • PGR positive
|
Verzenio (abemaciclib) • fulvestrant • Aliqopa (copanlisib)
Phase 1/2
National Cancer Institute (NCI)
Completed
Last update posted :
02/03/2025
Initiation :
11/24/2020
Primary completion :
02/07/2023
Completion :
05/19/2023
HER-2 • PD-L1 • ER • PGR • CD4
|
HER-2 amplification • HER-2 negative
|
bintrafusp alfa (M7824) • SX-682 • Panvac-VF (falimarev/inalimarev)
Phase 1
National Cancer Institute (NCI)
Active, not recruiting
Last update posted :
01/29/2025
Initiation :
09/01/2020
Primary completion :
12/31/2025
Completion :
12/31/2025
CD4
|
HER-2 positive • HER-2 amplification • HER-2 expression
|
Enhertu (fam-trastuzumab deruxtecan-nxki)
Phase 2
SWOG Cancer Research Network
Active, not recruiting
Last update posted :
01/14/2025
Initiation :
11/27/2017
Primary completion :
11/01/2022
Completion :
11/30/2025
HER-2 • KRAS • BRAF • NRAS
|
BRAF V600E • HER-2 amplification • BRAF V600
|
Herceptin (trastuzumab) • Erbitux (cetuximab) • Perjeta (pertuzumab) • irinotecan • Trazimera (trastuzumab-qyyp)
Phase 2
Fox Chase Cancer Center
Active, not recruiting
Last update posted :
01/10/2025
Initiation :
06/13/2017
Primary completion :
12/01/2025
Completion :
12/01/2025
HER-2
|
HER-2 overexpression • HER-2 amplification
|
Herceptin (trastuzumab) • Tecentriq (atezolizumab) • paclitaxel • Perjeta (pertuzumab)
Phase 3
Hoffmann-La Roche
Active, not recruiting
Last update posted :
12/20/2024
Initiation :
02/05/2020
Primary completion :
12/13/2021
Completion :
11/11/2025
PIK3CA
|
HER-2 positive • HER-2 amplification • PIK3CA mutation • EGFR positive
|
Herceptin (trastuzumab) • docetaxel • tamoxifen • doxorubicin hydrochloride • cyclophosphamide • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk) • cyclophosphamide intravenous
Phase 2
Georgetown University
Completed
Last update posted :
12/03/2024
Initiation :
05/21/2018
Primary completion :
11/03/2021
Completion :
05/02/2024
HER-2
|
HER-2 amplification • HER-2 negative
|
Opdivo (nivolumab) • capecitabine
Phase 3
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Un...
Recruiting
Last update posted :
11/28/2024
Initiation :
03/14/2023
Primary completion :
02/16/2028
Completion :
11/01/2028
HER-2 • ER • PGR
|
HER-2 positive • HR positive • HER-2 amplification • HER-2 amplification + HR-positive
|
Herceptin (trastuzumab) • Nerlynx (neratinib) • Perjeta (pertuzumab)
Phase 2
Brown University
Recruiting
Last update posted :
11/25/2024
Initiation :
07/14/2023
Primary completion :
01/01/2025
Completion :
01/01/2027
HER-2
|
HER-2 overexpression • HER-2 amplification
|
Opdivo (nivolumab) • Enhertu (fam-trastuzumab deruxtecan-nxki)
Phase 2
Adrienne G. Waks
Active, not recruiting
Last update posted :
11/06/2024
Initiation :
06/21/2018
Primary completion :
05/01/2023
Completion :
05/31/2025
HER-2 • PD-L1
|
HER-2 positive • HER-2 amplification
|
Herceptin (trastuzumab) • Perjeta (pertuzumab) • Bavencio (avelumab) • vinorelbine tartrate • utomilumab (PF-05082566)
Phase 2
Marina N Sharifi
Recruiting
Last update posted :
10/30/2024
Initiation :
02/12/2021
Primary completion :
09/01/2025
Completion :
01/01/2026
HER-2 • PIK3CA
|
HER-2 amplification • HER-2 negative • PIK3CA mutation • HR positive + HER-2 negative
|
Piqray (alpelisib) • fulvestrant
Phase 3
Daiichi Sankyo
Active, not recruiting
Last update posted :
10/24/2024
Initiation :
05/21/2021
Primary completion :
10/01/2025
Completion :
02/01/2026
HER-2
|
HER-2 positive • HER-2 amplification
|
paclitaxel • Enhertu (fam-trastuzumab deruxtecan-nxki) • Cyramza (ramucirumab)
Phase 1/2
DualityBio Inc.
Recruiting
Last update posted :
10/03/2024
Initiation :
01/31/2022
Primary completion :
04/01/2026
Completion :
10/01/2027
HER-2
|
HER-2 positive • HER-2 amplification • HER-2 expression
|
Perjeta (pertuzumab) • trastuzumab pamirtecan (BNT323) • itraconazole • ritonavir
Phase 1
Bayer
Completed
Last update posted :
09/27/2024
Initiation :
07/02/2020
Primary completion :
08/21/2023
Completion :
09/26/2023
HER-2
|
HER-2 overexpression • HER-2 amplification • HER-2 mutation • HER-2 underexpression
|
BAY2701439 • BAY2701438
Phase 2
Dana-Farber Cancer Institute
Recruiting
Last update posted :
09/19/2024
Initiation :
12/18/2020
Primary completion :
07/17/2025
Completion :
07/17/2029
HER-2 • ER • PGR • BRCA1 • BRCA2 • BRCA
|
HER-2 amplification • HER-2 negative • PALB2 mutation • PGR positive
|
Zejula (niraparib) • Jemperli (dostarlimab-gxly)
Phase 2
The Netherlands Cancer Institute
Recruiting
Last update posted :
08/21/2024
Initiation :
05/02/2024
Primary completion :
10/01/2027
Completion :
10/01/2034
HER-2 • ER
|
HER-2 positive • HER-2 amplification
|
Enhertu (fam-trastuzumab deruxtecan-nxki)
Phase 2
Dana-Farber Cancer Institute
Active, not recruiting
Last update posted :
08/20/2024
Initiation :
03/08/2019
Primary completion :
09/30/2021
Completion :
12/30/2024
HER-2 • PGR • TMB
|
HR positive • HER-2 amplification • HER-2 negative • ER positive + PGR positive • PGR positive
|
Opdivo (nivolumab) • Yervoy (ipilimumab)
Phase 2
Dana-Farber Cancer Institute
Active, not recruiting
Last update posted :
08/07/2024
Initiation :
01/01/2015
Primary completion :
06/01/2018
Completion :
01/01/2028
HER-2
|
HER-2 positive • HER-2 amplification
|
Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine)