Clinical trials: HER2 Mutations
BARD1 Gene Mutation, BRCA1 Gene Mutation
Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)
This randomized clinical trial studies how well online genetics educational video with or without pre- and/or post-telephone genetics counseling works in assessing cancer-risk distress in patients with triple negative breast…
- Conditions
- BARD1 Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, BRIP1 Gene Mutation
- Trial name
- NCT02993068
- Testing
- Educational Intervention, Genetic Counseling, Laboratory Biomarker Analysis
- Where
- 2 sites in United States
- Volunteers
- 5,200 people
- Sponsor
- M.D. Anderson Cancer Center
Estrogen-receptor-positive Breast Cancer, Metastatic Breast Cancer
PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)
The goal of this research study is to compare a combination of two drugs, capecitabine and elacestrant to capecitabine alone as a treatment for advanced estrogen receptor-positive (ER+) breast cancer.
- Conditions
- Estrogen-receptor-positive Breast Cancer, Metastatic Breast Cancer, Breast Cancer, Hormone Receptor Positive Breast Cancer
- Trial name
- CAPELA (NCT07222215)
- Testing
- Capecitabine, Elacestrant
- Where
- United States
- Volunteers
- 297 people
- Sponsor
- Kristina A. Fanucci
Advanced Breast Cancer, ER-positive Breast Cancer
Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.
This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive/human epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated.
- Conditions
- Advanced Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, ESR1 Gene Mutation
- Trial name
- ADELA (NCT06382948)
- Testing
- Everolimus, Elacestrant, Auxiliary Medicinal Product - Dexamethasone
- Where
- 104 sites in Austria, Brazil and 7 more
- Volunteers
- 300 people
- Sponsor
- MedSIR
Uterine Neoplasms, Uterine Cervical Neoplasms
Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the…
- Conditions
- Uterine Neoplasms, Uterine Cervical Neoplasms, Biliary Tract Neoplasms, Urologic Neoplasms
- Trial name
- NCT04579380
- Testing
- tucatinib, trastuzumab, fulvestrant
- Where
- 108 sites in United States, Belgium and 6 more
- Volunteers
- 217 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
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
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
Breast Cancer, Ovarian Cancer
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational…
- Conditions
- Breast Cancer, Ovarian Cancer, Endometrial Cancer, PIK3CA Mutation
- Trial name
- NCT07524322
- Testing
- RGT-490
- Where
- 5 sites in United States
- Volunteers
- 63 people
- Sponsor
- Regor Pharmaceuticals Inc.
Advanced Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations.
An international, multicenter, two-stage optimal Simon's design, single-arm phase II clinical trial to evaluate zongertinib plus fulvestrant combination therapy in participants with hormone receptor-positive/HER2-negative…
- Conditions
- Advanced Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer, HER2 Mutation
- Trial name
- AGATHA (NCT07619066)
- Testing
- Zongertinib (BI 1810631), Fulvestrant
- Volunteers
- 25 people
- Sponsor
- MedSIR
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
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
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
Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer
Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations
This is a Phase 1b, open-label, multi-center, dose-escalation and dose expansion study designed to evaluate the safety, pharmacokinetics (PK), and preliminary antitumor activity of furmonertinib in patients with advanced or…
- Conditions
- Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, HER2 Exon 20 Mutations
- Trial name
- NCT05364073
- Testing
- Furmonertinib
- Where
- 42 sites in United States, Australia and 9 more
- Volunteers
- 160 people
- Sponsor
- ArriVent BioPharma, Inc.
Breast Cancer - ER+, HER2-, PIK3CA Gene Mutation
PI3K Pathway Activation Markers in ER-Positive, HER2-Negative Breast Cancer: A Clinicopathologic Study
The goal of this observational study is to examine whether markers of PI3K pathway activation are associated with endocrine therapy response and clinicopathologic features in estrogen receptor-positive, HER2-negative breast…
- Trial name
- p-AKT p-S6 (NCT07387861)
- Testing
- Not applicable- observational study
- Volunteers
- 70 people
- Sponsor
- Assiut University
Pancreatic Adenocarcinoma Metastatic, BRCA1 Mutation
SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells
The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic pancreatic cancer and metastatic breast cancer.
- Conditions
- Pancreatic Adenocarcinoma Metastatic, BRCA1 Mutation, BRCA2 Mutation, Pancreatic Acinar Cell Carcinoma
- Trial name
- SHARON (NCT04150042)
- Testing
- Melphalan, BCNU, Vitamin B12B
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- General Oncology, Inc.
Non-Small Cell Lung Cancer With HER2- Mutations
A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations
The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 versus Standard of Care as first-line treatment of advanced or metastatic Non-Small Cell Lung Cancer with HER2- Mutations
- Trial name
- NCT06430437
- Testing
- SHR-A1811, PD-1/PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Non-squamous NSCLC, HER2 Exon 20 Mutation
Phase 3 Study of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous NSCLC Harboring a HER2 Exon 20 Mutation Who Failed Platinum Based Chemotherapy
This is a randomized, positive-controlled, open-label, international multicenter, Phase 3 clinical study to compare the efficacy and safety of pyrotinib versus docetaxel in patients with advanced non-squamous NSCLC harboring a…
- Trial name
- PYRAMID-1 (NCT04447118)
- Testing
- Pyrotinib, Docetaxel
- Where
- 102 sites in United States, Australia and 11 more
- Volunteers
- 151 people
- Sponsor
- Jiangsu HengRui Medicine 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
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.
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.
HER2 Mutant Non-small Cell Lung Cancer, HER2-positive Metastatic Breast Cancer
ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer
The goal of this clinical trial is to test ELVN-002 in people with cancers that have an abnormal HER2 gene. The main question the trial aims to answer is if ELVN-002 is safe and tolerable at different doses.
- Conditions
- HER2 Mutant Non-small Cell Lung Cancer, HER2-positive Metastatic Breast Cancer, HER2 Gene Mutation, HER2 Amplification
- Trial name
- HER2 (NCT05650879)
- Testing
- ELVN-002, Fam-Trastuzumab Deruxtecan-Nxki, Trastuzumab emtansine
- Where
- 39 sites in United States, Australia and 5 more
- Volunteers
- 198 people
- Sponsor
- Enliven Therapeutics