Clinical trials: HER2 Mutations
Lung Cancer (NSCLC), EGFR Activating Mutation
First-line Therapy With Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor(EGFR-TKI) Combined With Trastuzumab Rezetecan for Advanced Non-small Cell Lung Cancer(NSCLC) Harboring EGFR Mutations Concomitant With Human Epidermal Growth Factor Receptor 2(HER2) Alterations
To explore the efficacy and safety of first-line EGFR-TKI combined with Trastuzumab Rezetecan in advanced NSCLC patients harboring EGFR mutations with concomitant HER2 genomic alterations or HER2 protein expression (1+/2+/3+)
- Conditions
- Lung Cancer (NSCLC), EGFR Activating Mutation, HER2
- Trial name
- NCT07699952
- Testing
- Almonertinib, Trastuzumab Rezetecan
- Volunteers
- 35 people
- Sponsor
- Yongsheng Wang
Breast Cancer
A Phase Ib Study of HS-10352 Plus Fulvestrant in Patients With Advanced Breast Cancer
HS-10352 is a highly potent and selective small molecule inhibitor of phosphoinositide 3-kinase (p110α). The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10352 plus…
- Trial name
- NCT05504213
- Testing
- HS-10352 combined with fulvestrant (Stage 1), HS-10352 combined with fulvestrant (Stage 2)
- Where
- China
- Volunteers
- 224 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting
This was a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation…
- Trial name
- NCT04967248
- Testing
- Alpelisib, Fulvestrant
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations
This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless…
- Trial name
- DPT01 (NCT04639219)
- Testing
- Trastuzumab deruxtecan
- Where
- 30 sites in United States, Belgium and 7 more
- Volunteers
- 102 people
- Sponsor
- AstraZeneca
Colorectal Cancer Metastatic, Brain Metastases, Adult
Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Colorectal Cancer
GENCONCOR-1 study is translational research aimed to investigate the concordance of the molecular genetic profile of the primary tumor and brain metastases (BM) of colorectal cancer (CRC).
- Conditions
- Colorectal Cancer Metastatic, Brain Metastases, Adult, Ras (KRAS or NRAS) Gene Mutation, BRAF Gene Mutation
- Trial name
- GENCONCOR-1 (NCT06449989)
- Testing
- Tumor samples will be tested for mutation status of KRAS, NRAS, BRAF, HER2 and MSI
- Where
- Russia
- Volunteers
- 30 people
- Sponsor
- Blokhin's Russian Cancer Research Center
Germline BRCA-mutated HER2-negative Breast Cancer
Fluzoparib Combined With Camrelizumab for Neoadjuvant Treatment of Embryogenic BRCA Mutation HER2 Negative Breast Cancer: an Open, Single Arm, Multicenter Study
This study is an open-label, single-arm, multicenter clinical study. 64 patients with germline BRCA-mutated HER2-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with camrelizumab to…
- Trial name
- NCT05576389
- Testing
- Camrelizumab+Fluzoparib
- Where
- China
- Volunteers
- 64 people
- Sponsor
- Peking University People's Hospital
ER-positive and HER2-negative Metastatic or Locally Advanced Breast Cancer, a Germline or Somatic BRCA Mutation, or a Deleterious Alteration of Other Genes Involved in Homologous Recombination Repair (HRR) or in MSI Status
Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients.
This study evaluates the efficacy of the combination of olaparib, durvalumab, and fulvestrant for the treatment of patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer with BRCA gene alterations…
- Trial name
- DOLAF (NCT04053322)
- Testing
- Durvalumab, Olaparib, Fulvestrant
- Where
- 2 sites in France
- Volunteers
- 172 people
- Sponsor
- UNICANCER
HER2-positive Breast Cancer
PIK3CA in HER2+ BC and pCR Trial
The goal of the study is to evaluate the impact of somatic PI3KCA mutations on pCR in HER2-positive early breast cancer in real life. The main question it aims to answer iS.
- Trial name
- NCT05750693
- Testing
- PIK3CA analysis
- Where
- Italy
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Advanced Breast Cancer
Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer
The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as…
- Trial name
- EvoPAR-BR01 (NCT06380751)
- Testing
- Saruparib (AZD5305), Camizestrant, Abemaciclib
- Where
- 306 sites in United States, Argentina and 27 more
- Volunteers
- 788 people
- Sponsor
- AstraZeneca
Biliary Tract Cancer, HER2 Gene Mutation
Efficacy and Safety of GemCis Plus Trastuzumab Plus Pembrolizumab in Previously Untreated HER2-positive Biliary Tract Cancer
This is a multicenter, single arm, prospective, open-label phase II trial investigating the clinical activity triplet regimen consisting of a combination of chemotherapy (gemcitabine/cisplatin) + trastuzumab + pembrolizumab as…
- Conditions
- Biliary Tract Cancer, HER2 Gene Mutation, HER2
- Trial name
- TRAP-BTC (NCT06178445)
- Testing
- SOC plus trastuzumab and pembrolizumab
- Where
- 8 sites in Germany
- Volunteers
- 24 people
- Sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Anatomic Stage IV Breast Cancer AJCC v8, HER2-Positive Breast Carcinoma
Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer
This phase Ib/II trial studies the side effects and best dose of copanlisib when given together with trastuzumab and pertuzumab and to see how well they work after induction treatment in treating patients with HER2 positive stage…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, HER2-Positive Breast Carcinoma, Metastatic Breast Carcinoma
- Trial name
- NCT04108858
- Testing
- Copanlisib, Pertuzumab, Trastuzumab
- Where
- 5 sites in United States
- Volunteers
- 2 people
- Sponsor
- National Cancer Institute (NCI)
ER+ Breast Cancer, Ovarian Cancer
Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumor, Including a Cohort Expansion in Esophageal Cancer.
This Phase 1b is a dose escalation, MTD expansion and cohort expansions study to assess the safety and tolerability of a combination of NAP with durvalumab in subjects with selected advanced or metastatic solid tumors.
- Conditions
- ER+ Breast Cancer, Ovarian Cancer, Cervical Squamous Cell Carcinoma, Pancreatic Adenocarcinoma
- Trial name
- NCT03983954
- Testing
- Obinutuzumab, naptumomab estafenatox and durvalumab, Naptumomab estafenatox and durvalumab
- Where
- 9 sites in India, Israel
- Volunteers
- 120 people
- Sponsor
- NeoTX Therapeutics Ltd.
Ovarian Cancer, Breast Cancer
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib
The rationale of the ROSY-O study is to continue to provide study treatment for patients who have participated in a parent study with olaparib and who are continuing to derive clinical benefit from treatment at the end of such…
- Trial name
- ROSY-O (NCT04421963)
- Testing
- Olaparib
- Where
- 107 sites in United States, Belgium and 21 more
- Volunteers
- 185 people
- Sponsor
- AstraZeneca
HER2 Positive Breast Neoplasms, Hormone Receptor Positive Breast Neoplasms
A Safety Study of SGN-LIV1A in Breast Cancer Patients
This study will examine the safety and tolerability of ladiratuzumab vedotin (LV) in patients with metastatic breast cancer. LV will be given alone or in combination with trastuzumab.
- Conditions
- HER2 Positive Breast Neoplasms, Hormone Receptor Positive Breast Neoplasms, Triple Negative Breast Neoplasms, HER2 Mutations Breast Neoplasms
- Trial name
- NCT01969643
- Testing
- ladiratuzumab vedotin, Trastuzumab
- Where
- 38 sites in United States
- Volunteers
- 290 people
- Sponsor
- Seagen Inc.
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Effect of HSD3B1 (1245C) Gene Mutation on Treatment of Stage I-III Breast Cancer
This stage IV trial examines how a mutation in HSD3B1 (1245C) gene affects treatment of stage I-III breast cancer. This trial may help researchers determine if mutations in HSD3B1 decreases the efficacy of aromatase inhibitor…
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Breast Adenocarcinoma
- Trial name
- NCT05183828
- Testing
- Biospecimen Collection, Letrozole, Questionnaire Administration
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- University of Washington
ER Positive, HER2 Positive Breast Cancer
Elacestrant in Advanced Triple Positive Breast Cancer
The purpose of this study to assess the safety and efficacy of elacestrant, a selective estrogen receptor degrader (SERD) and dual biologic therapy, trastuzumab and pertuzumab, in patients with triple-positive breast cancer with…
- Trial name
- NCT07612215
- Testing
- Elacestrant, Trastuzumab, Pertuzumab
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- NYU Langone Health
HER2-negative Breast Cancer, Gastric Adenocarcinoma
Niraparib Combined With Anlotinib in Homologous Recombination Repair (HRR) Gene-mutated Advanced Solid Tumors
Homologous Recombination Repair (HRR) gene mutations can be detected in many solid tumors, patients with HRR gene mutations may benefit from PARP inhibitor.
- Conditions
- HER2-negative Breast Cancer, Gastric Adenocarcinoma, Cholangiocarcinoma, Pancreatic Cancer
- Trial name
- NCT04764084
- Testing
- Niraparib, Anlotinib
- Where
- China
- Volunteers
- 52 people
- Sponsor
- Peking University Cancer Hospital & Institute
Safety
Almonertinib Combined With Pyrotinib in the Treatment of Advanced NSCLC Patients With HER-2 Amplification/Mutation After EGFR-TKI Resistance
This is a multicenter, open, phase II clinical trial to evaluate the safety and efficacy of almonertinib combined with pyrrolitinib in locally advanced or metastatic NSCLC patients with her-2 variants detected after first-line…
- Trial name
- APPEAR (NCT04785729)
- Testing
- Almonertinib combine with Pyrrolitinib
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Sun Yat-sen University
Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Stage III
Her2-positive Lung Cancer Treated With Dedicated Drug
HER2 (erbB-2/neu) is a member of the erbB receptor tyrosine kinase family. ERBB2 gene which encodes human epidermal growth factor 2 (HER2) is a major proliferative driver activating downstream signaling through PI3K-AKT and…
- Conditions
- Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Stage III, HER2 Gene Mutation
- Trial name
- R2D2 (NCT03845270)
- Testing
- pertuzumab + trastuzumab + docetaxel
- Where
- 18 sites in France
- Volunteers
- 46 people
- Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
PIK3CA Mutation, Solid Tumor, Adult
First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer
This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-2608, in advanced solid tumor…
- Conditions
- PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- NCT05216432
- Testing
- RLY-2608, Fulvestrant, Palbociclib 125mg
- Where
- 37 sites in United States, Australia and 3 more
- Volunteers
- 930 people
- Sponsor
- Relay Therapeutics, Inc.