Clinical trials: HER2 Gene Mutation
Breast Cancer
Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer
The objective of this non-interventional study (NIS) is to evaluate prevalence of ESR1 mutation after endocrine therapy in the palliative setting, quality of life, tolerability, and safety and to describe treatment detail and…
- Trial name
- ELENI (NCT07563595)
- Testing
- Elacestrant, Standard of care (Investigator Choice)
- Where
- 3 sites in Germany
- Volunteers
- 500 people
- Sponsor
- iOMEDICO AG
Salivary Gland Cancer, HER2 Gene Mutation
Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas
This research is being done to see how safe and effective the use of the study drug Ado-trastuzumab (T) emtansine (DM1), T-DM1, and standard of care chemoradiation are when used together in treating HER2-positive salivary gland…
- Trial name
- NCT04620187
- Testing
- Ado-trastuzumab (T) emtansine (T-DM1), Standard of Care Radiotherapy, Standard of Care Chemotherapy
- Where
- 13 sites in United States
- Volunteers
- 37 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer
Study Evaluating DNA Double-strand Breaks (DSBs) REpair Factors (POLQ, Shieldin Complex and 53BP1) Expression as Biomarker of PARP Inhibitor Resistance in Patients With Deleterious Germline Mutation in BRCA 1/2 and HER2-negative, Metastatic or Locally Advanced Breast Cancer.
The purpose of this study is to assess whether expression of not only POLQ/Polθ, but also Shieldin complex and/or 53BP1 are correlated with primary and/or acquired resistance to PARPi (Poly(ADP-Ribose) Polymerases inhibitors) in…
- Trial name
- REPARP (NCT05378204)
- Testing
- Main study:, Sub-study:
- Where
- 25 sites in France
- Volunteers
- 120 people
- Sponsor
- Institut Claudius Regaud
Metastatic Triple Negative Breast Cancer
To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.
This study is to assess the efficacy and safety of olaparib monotherapy versus olaparib in combination with an inhibitor of ATR (Ataxia-Telangiectasia Mutated (ATM) and Rad3-related protein kinase (Ceralasertib [AZD6738]) and…
- Trial name
- NCT03330847
- Testing
- Olaparib Continuous (28-Day cycle) 300 mg BD., Ceralasertib 160 mg OD + olaparib continuous 300 mg BD (28-day cycle)., Adavosertib 150 mg BD + olaparib 200 mg BD (21-day cycle).
- Where
- 141 sites in United States, Belgium and 13 more
- Volunteers
- 273 people
- Sponsor
- AstraZeneca
Advanced Solid Malignancy, Safety and Tolerability
Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules
This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in patients with advanced cancer - and to identify a dose and schedule that can be used in the future.
- Conditions
- Advanced Solid Malignancy, Safety and Tolerability, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT01226316
- Testing
- AZD5363
- Where
- 34 sites in United States, Canada and 8 more
- Volunteers
- 285 people
- Sponsor
- AstraZeneca
Advanced Non-small Cell Lung Cancer, HER2 Mutation
A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations.
- Trial name
- SOHO-02 (NCT06452277)
- Testing
- Sevabertinib, Pembrolizumab, Cisplatin
- Where
- 279 sites in United States, Argentina and 34 more
- Volunteers
- 444 people
- Sponsor
- Bayer
Advanced Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8
Olaparib With Cediranib or AZD6738 for the Treatment of Advanced or Metastatic Germline BRCA Mutated Breast Cancer
This phase II trial studies how well olaparib with cediranib or AZD6738 works in treating patients with germline BRCA mutated breast cancer that has spread to other places in the body (advanced or metastatic).
- Conditions
- Advanced Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8
- Trial name
- NCT04090567
- Testing
- Cediranib, Ceralasertib, Olaparib
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- M.D. Anderson Cancer Center
Non-small Cell Lung Cancer
Efficacy and Safety of Pyrotinib in Patients With HER2 Mutation Advanced Non-Small Cell Lung Cancer
Various driver gene mutations have been identified in lung cancer. Among them, human epidermal growth factor 2 (HER2) was identified in about approximately 2% of non-small cell lung cancers.Pyrotinib is an oral tyrosine kinase…
- Trial name
- NCT02535507
- Testing
- Pyrotinib
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Tongji University
Advanced Solid Tumors With HER2 Abnormalities, Advanced Solid Tumors With HER3 Abnormalities
A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities
This is a First-in-Human (FIH), 2-part, Phase 1/2, open-label, multicenter study design to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of TAS0728.
- Trial name
- NCT03410927
- Testing
- TAS0728
- Where
- 8 sites in United States, France and 2 more
- Volunteers
- 19 people
- Sponsor
- Taiho Oncology, Inc.
Breast Cancer, Ovarian Cancer
Phase I Clinical Trials Investigating the Potential Efficacy of Axitinib in Patients With a BRCA 1/2 Mutations
This Clinical Trial is investigating the potential efficacy of axitinib after genetic testing in BRCA 1/2 Mutation patients, regardless of HER2 expression, who have progressed after at least one line of standard treatment or for…
- Conditions
- Breast Cancer, Ovarian Cancer, Breast Neoplasms, Ovarian Neoplasms
- Trial name
- NCT05904730
- Testing
- Axitinib
- Where
- 2 sites in Ukraine
- Volunteers
- 10 people
- Sponsor
- Lynkcell Europe
Solid Tumor
A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.
This was a clinical study with an orally administered drug, BDTX-189 in participants with advanced solid tumors that had select mutations or alterations in human epidermal growth factor receptor 2 (HER2/ErbB2) genes or epidermal…
- Trial name
- MasterKey-01 (NCT04209465)
- Testing
- BDTX-189
- Where
- 38 sites in United States, Denmark and 2 more
- Volunteers
- 91 people
- Sponsor
- Black Diamond Therapeutics, Inc.
Her-2 Negative Breast Cancer, HRR Gene Mutation
Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation
This study is to evaluate the efficacy and safety of combination of Camrelizumab (Immunotherapy, PD-1 inhibitor), Fluzoparib (PARP inhibitor) and Nab-paclitaxel in neoadjuvant therapy of Her-2 negative breast cancer patients with…
- Trial name
- IMPARP (NCT05761470)
- Testing
- Camrelizumab, Fluzoparib, Nab-paclitaxel
- Where
- China
- Volunteers
- 66 people
- Sponsor
- Ying Lin
HER2-positive Breast Cancer, HER-2 Protein Overexpression
Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors
This is a Phase 1 first-in-human study of ORM-5029 in participants with HER2-expressing advanced solid tumors. The study consists of two parts: a Part 1 Dose Escalation and Part 2 Dose Expansion.
- Conditions
- HER2-positive Breast Cancer, HER-2 Protein Overexpression, HER-2 Gene Amplification, HER2 Gene Mutation
- Trial name
- NCT05511844
- Testing
- ORM-5029
- Where
- 11 sites in United States
- Volunteers
- 25 people
- Sponsor
- Orum Therapeutics USA, Inc.
Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer
A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
This is an open-label, phase 1/1b study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4255 in adult…
- Conditions
- Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer, ERBB2 Gene Amplification, HER2 Overexpression
- Trial name
- NCT07361562
- Testing
- CGT4255
- Where
- 15 sites in United States
- Volunteers
- 100 people
- Sponsor
- Cogent Biosciences, Inc.
Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer, Metastatic Cervical Cancer
HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
This is a multi-center, observational genomic screening protocol to identify participants whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) .
- Trial name
- NCT03786107
- Testing
- Almac HER-Seq Assay
- Where
- 22 sites in United States, France and 5 more
- Volunteers
- 1,583 people
- Sponsor
- Puma Biotechnology, Inc.
Breast Cancer, Triple Negative Breast Neoplasms
Assessing the Efficacy of Paclitaxel and Olaparib in Comparison to Paclitaxel / Carboplatin Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer and Homologous Recombination Deficiency
This is a multicenter, prospective, randomized, open-label phase II study evaluating the efficacy and safety of PO→EC as neoadjuvant treatment of operable and locally advanced breast cancer in patients with HR deficiency.
- Conditions
- Breast Cancer, Triple Negative Breast Neoplasms, HRpos Breast Neoplasms, BRCA 1 /2 and / or HRD
- Trial name
- GeparOla (NCT02789332)
- Testing
- PwO, PwCb, EC
- Where
- 12 sites in Germany
- Volunteers
- 107 people
- Sponsor
- GBG Forschungs GmbH
Non Small Cell Lung Cancer, ERBB2 Mutation-Related Tumors
Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations
Disitamab Vedotin combined therapy locally advanced or metastatic NSCLC Patients with HER2 Alterations.
- Conditions
- Non Small Cell Lung Cancer, ERBB2 Mutation-Related Tumors, RC48, Disitamab Vedotin
- Trial name
- NCT05847764
- Testing
- RC48+Tislelizumab+carboplatin, RC48+Furmonertinib, 1L, RC48+Furmonertinib, 2L+
- Where
- China
- Volunteers
- 95 people
- Sponsor
- Sun Yat-sen University
Lung Cancer
Disitamab Vedotin in Combination with Tislelizumab and Bevacizumab in a Phase II Clinical Study of Locally Advanced or Metastatic Non-small Cell Lung Cancer with HER2 Mutation/amplification/expression
The goal of this clinical trial is to learn ifDisitamab Vedotin in combination with tislelizumab and bevacizumab can treat in locally advanced or metastatic non-small cell lung cancer patients with HER2…
- Trial name
- NCT06749860
- Testing
- Disitamab Vedotin + tislelizumab + bevacizumab
- Where
- China
- Volunteers
- 58 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer
Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors
The objective of this study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M17D1 in patients with HER2-Expressing or HER2-Mutant Advanced or Metastatic Solid Tumors.
- Conditions
- Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer, Unresectable Breast Carcinoma, Her2-Positive
- Trial name
- NCT06714617
- Testing
- BL-M17D1
- Where
- 9 sites in United States
- Volunteers
- 3 people
- Sponsor
- SystImmune Inc.
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