Clinical trials: HER2 Mutations
Breast Cancer
International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study
BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study BREAKOUT is a prospective cross-sectional cohort study of human epidermal growth factor receptor 2 negative metastatic breast cancer…
- Trial name
- BREAKOUT (NCT03078036)
- Testing
- Germline BRCA Test (blood), FoundationOne Dx Genomic Profile (archival Tumour Specimen), Follow-up
- Where
- 98 sites in United States, Australia and 13 more
- Volunteers
- 873 people
- Sponsor
- AstraZeneca
Treatment in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation
A Study of Fluzoparib±Apatinib Versus Chemotherapy Treatment of Physician's Choice in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation
This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Physicians Choice Chemotherapy, as treatment, in patients with a Germline BRCA…
- Trial name
- NCT04296370
- Testing
- Fluzoparib; Apatinib, Fluzoparib, Physician's choice chemotherapy
- Where
- China
- Volunteers
- 474 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer, HER2-low Breast Cancer
Distribution of the Homologous Recombination-related (HRR) Genesmutationsand HRD in Breast Cancer
This is a cross-sectional and an observational study, investigator-initiated study in HER2-low breast cancer patients. Approximately 255 subjects with HRD (homologous recombination deficiency) assessment will be enrolled in this…
- Trial name
- NCT05466786
- Testing
- Standard Management
- Where
- China
- Volunteers
- 255 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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.
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
NSCLC (Advanced Non-small Cell Lung Cancer)
A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
This Phase1/2, open label, multicenter study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with NSCLC having EGFR and/or HER2 mutations.
- Trial name
- SOLARA (NCT06706076)
- Testing
- BH-30643, BH-30643 combo therapy with Carboplatin/Pemetrexed
- Where
- 42 sites in United States, Australia and 7 more
- Volunteers
- 675 people
- Sponsor
- BlossomHill Therapeutics
Metastatic Breast Cancer
Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
This is an open-label, multicenter, single-arm safety study evaluating the safety and tolerability of the lasofoxifene and abemaciclib combination for the treatment of pre- and postmenopausal women with locally advanced or…
- Trial name
- ELAINEII (NCT04432454)
- Testing
- Lasofoxifene and abemaciclib (VERZENIO (R)).
- Where
- 16 sites in United States
- Volunteers
- 29 people
- Sponsor
- Sermonix Pharmaceuticals Inc.
Metastatic Breast Cancer, Locally Advanced Breast Cancer
HOPE: Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, HR+, HER2-metastatic Breast Cancer
The main purpose of this research study is to learn whether the investigational combination of olaparib, palbociclib, and fulvestrant is safe in patients with estrogen receptor-positive breast cancer and BRCA1 or BRCA2 mutations.
- Conditions
- Metastatic Breast Cancer, Locally Advanced Breast Cancer, Advanced Breast Cancer, BRCA2 Mutation
- Trial name
- NCT03685331
- Testing
- Palbociclib, Olaparib, Fulvestrant
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Breast Adenocarcinoma, Deleterious BRCA1 Gene Mutation
Talazoparib Before Standard Therapy in Treating Patients With Invasive, BRCA-Mutated Breast Cancer
This phase II trial studies the side effects of talazoparib when given before standard therapy in treating patients with breast cancer that has spread to nearby healthy tissue and has a mutation in a breast cancer, early onset…
- Conditions
- Breast Adenocarcinoma, Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation, HER2/Neu Negative
- Trial name
- NCT02282345
- Testing
- Laboratory Biomarker Analysis, Talazoparib
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- M.D. Anderson Cancer Center
Advanced Breast Cancer
Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With Fulvestrant
The study was designed to identify and register practical observations and experiences in connection with planning and implementing decentralized, patient-centered clinical trials at a geographic distance with virtual elements.
- Trial name
- TELEPIK (NCT04862143)
- Testing
- Alpelisib, Fulvestrant, Goserelin
- Where
- Sweden
- Volunteers
- 2 people
- Sponsor
- Novartis Pharmaceuticals
Haematological Malignancy, Colorectal Neoplasms
DETERMINE Trial Treatment Arm 04: Trastuzumab in Combination With Pertuzumab in Adult, Paediatric and Teenage/Young Adult Patients With Cancers With HER2 Amplification or Activating Mutations
This clinical trial is looking at a combination of drugs called trastuzumab and pertuzumab. This combination of drugs is approved together as standard of care treatment for adult patients with breast cancer (often with other…
- Conditions
- Haematological Malignancy, Colorectal Neoplasms, Urinary Bladder Neoplasm, Gallbladder Neoplasms
- Trial name
- DETERMINE (NCT05786716)
- Testing
- Trastuzumab, Pertuzumab
- Where
- 27 sites in United Kingdom
- Volunteers
- 30 people
- Sponsor
- Cancer Research UK
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
Breast Cancer
A Non-interventional Prospective Study of Early HER2-negative High-risk Breast Cancer and BRCA1/2 Mutations Prevalence in RussiA
(Neo)adjuvant treatment approaches and outcomes
- Trial name
- ERA (NCT05939128)
- Where
- 19 sites in Russia
- Volunteers
- 625 people
- Sponsor
- AstraZeneca
Urothelial Carcinoma
A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2
This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants.
- Trial name
- NCT04879329
- Testing
- disitamab vedotin, pembrolizumab
- Where
- 221 sites in United States, Argentina and 10 more
- Volunteers
- 372 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
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
Cancers Harbouring an EGFR Mutation, (Excluding Non-squamous Non- Small Cell Lung Cancer, a Registered Indication), a HER2 Mutation or a HER3 Mutation
An Explorative Study of Afatinib in the Treatment of Advanced Cancer Carrying an EGFR, a HER2 or a HER3 Mutation
Objective(s):To investigate the efficacy and safety of afatinib in EGFR, HER 2 and HER3 mutated cancers, regardless of cancer type, excluding EGFR mutated non-small cell lung cancer.
- Trial name
- NCT03810872
- Testing
- Afatinib, Paclitaxel
- Where
- 5 sites in Belgium
- Volunteers
- 87 people
- Sponsor
- Universitair Ziekenhuis Brussel
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Testing Afatinib as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol B)
This phase II MATCH treatment trial identifies the effects of afatinib in patients whose cancer has genetic changes called HER2 mutations.
- Conditions
- Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma
- Trial name
- NCT04439136
- Testing
- Afatinib Dimaleate
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- National Cancer Institute (NCI)
HER2 Insertion Mutation Positive Advanced NSCLC
PD-1 Combined With Pyrotinib for Chemotherapy Failure HER2 Insertion Mutation Advanced NSCLC
The purpose of this study is to assess the safety and effectiveness of PD-1 Combined With Pyrotinib for First-line chemotherapy failed HER2 Insertion Mutation Positive Advanced Non-small Cell Lung Cancer
- Trial name
- NCT04144569
- Testing
- PD-1 Combined With Pyrotinib
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Yongchang Zhang
Breast Cancer
Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients
Men and post- or induced menopausal women with ER[+] and/or PgR[+], HER2[- ] advanced BC, with centrally-confirmed PI3KCAMut who progressed to an aromatase inhibitor (AI) regimen.
- Trial name
- METALLICA (NCT04300790)
- Testing
- Alpelisib, Metformin, Fulvestrant
- Where
- 19 sites in Spain
- Volunteers
- 69 people
- Sponsor
- MedSIR
Hormone Receptor Positive Breast Carcinoma, Breast Neoplasms
Monitoring luminAl Breast Cancer Through the Evaluation of Mutational and epiGeNEtic alteraTIons of Circulating ESR1 DNA
The purpose of the study is to determine the diagnostic role of ctDNA when used to monitor metastatic breast cancer (MBC) during first-line endocrine therapy.
- Conditions
- Hormone Receptor Positive Breast Carcinoma, Breast Neoplasms, Neoplasms, Breast, Breast Diseases
- Trial name
- MAGNETIC1 (NCT05814224)
- Testing
- Liquid biopsy and CT scan
- Where
- 7 sites in Italy
- Volunteers
- 164 people
- Sponsor
- Centro di Riferimento Oncologico - Aviano