Clinical trials: HER2
HER2-positive Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer
This is a Phase Ⅲ, randomized, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab…
- Trial name
- NCT06764875
- Testing
- Rilvegostomig, Trastuzumab deruxtecan, Trastuzumab
- Where
- 304 sites in United States, Argentina and 26 more
- Volunteers
- 840 people
- Sponsor
- AstraZeneca
HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma
Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer
Antibody-drug conjugates (ADCs) have demonstrated substantial improvement in progression free survival (PFS) and overall survival (OS) in phase III clinical trials in patients with metastatic triple negative breast cancer (mTNBC)…
- Conditions
- HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma, Metastatic Breast Cancer, HR+ HER2 Breast Cancer
- Trial name
- ENCORE (NCT06774027)
- Testing
- Specimen collection, Non-Investigational Antibody-Drug Conjugates (ADC), Medical Record Review
- Where
- 3 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer
This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Locally Advanced Breast Carcinoma
- Trial name
- NCT07137416
- Testing
- Biopsy Procedure, Biospecimen Collection, Echocardiography Test
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- National Cancer Institute (NCI)
Advanced Breast Cancer, Metastatic Breast Cancer
T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd
This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4/6i + ET and the opportunity to…
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer, HER2 Positive, HR Positive
- Trial name
- DB-Guide (NCT07683754)
- Testing
- Trastuzumab deruxtecan, Trastuzumab, Pertuzumab
- Where
- 5 sites in United States
- Volunteers
- 200 people
- Sponsor
- Daiichi Sankyo
Breast Cancer, Metastatic Breast Cancer
Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer
This is a phase 2, open-label, singled-arm clinical trial determining efficacy of combination therapy with anastrozole, fulvestrant and abemaciclib in subjects with breast cancer.
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- NCT05524584
- Testing
- Fulvestrant, Anastrozole, Abemaciclib
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, Irvine
Advanced Solid Tumor, Advanced Breast Cancer
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in…
- Conditions
- Advanced Solid Tumor, Advanced Breast Cancer, Metastatic Breast Cancer, Hormone-receptor-positive Breast Cancer
- Trial name
- NCT06120283
- Testing
- BGB-43395, Fulvestrant, Letrozole
- Where
- 61 sites in United States, Australia and 9 more
- Volunteers
- 433 people
- Sponsor
- BeOne Medicines
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
HER2-Low Unresectable/Metastatic Breast Cancer Complicated With Visceral Crisis
The Efficacy and Safety of Trastuzumab Rezetecan (SHR-A1811) in HER2-Low Unresectable/Metastatic Breast Cancer Patients With Visceral Crisis
The goal of this clinical trial is to learn if Trastuzumab Rezetecan (SHR-A1811) is safe and tolerable for patients with HER2-Low unresectable/metastatic breast cancer complicated with visceral crisis.
- Trial name
- NCT07203729
- Testing
- Trastuzumab Rezetecan, Chemotherapy of Physician's Choice
- Where
- China
- Volunteers
- 184 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
HER2-positive Breast Cancer, Metastatic Breast Cancer
SMP-656 for HER2-Positive Advanced Breast Cancer
The goal of this clinical trial is to learn if single-agent SMP-656 works to treat patients with HER2-positive locally advanced or metastatic breast cancer who have progressed after prior HER2-targeted topoisomerase inhibitor…
- Conditions
- HER2-positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC)
- Trial name
- NCT07726342
- Testing
- SMP-656 Injection
- Where
- 15 sites in China
- Volunteers
- 60 people
- Sponsor
- Chengdu SciMount Pharmatech Co., Ltd.
Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer
A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment
The purpose of this study is to evaluate treatment adherence, tolerability, and patient-reported outcomes of participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast…
- Conditions
- Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer
- Trial name
- kalitERA (NCT07827573)
- Testing
- Giredestrant
- Volunteers
- 1,500 people
- Sponsor
- Hoffmann-La Roche
Solid Tumors (Phase 1), HNSCC
MTX-531-001 Phase 1 Study in Advanced Solid Tumors
This is a first-in-human, Phase 1, open-label study evaluating MTX-531, an investigational dual EGFR/PI3K inhibitor, in adults with advanced solid tumors.
- Conditions
- Solid Tumors (Phase 1), HNSCC, Endometrial Cancer, Her2-negative Metastatic Breast Cancer
- Trial name
- NCT07874880
- Testing
- MTX-531
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- MEKanistic Therapeutics, Inc.
Advanced Solid Tumor, Locally Advanced Solid Tumor
A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
TransCon IL-2 β/γ is an investigational drug being developed for treatment of locally advanced or metastatic solid tumors. This is a first-in-human, open-label, Phase 1/2, dose escalation and dose expansion study of TransCon IL-2…
- Conditions
- Advanced Solid Tumor, Locally Advanced Solid Tumor, Metastatic Solid Tumor, Platinum-resistant Ovarian Cancer
- Trial name
- IL Believe (NCT05081609)
- Testing
- TransCon IL-2 β/γ, Pembrolizumab, Chemotherapy drug
- Where
- 68 sites in United States, Australia and 8 more
- Volunteers
- 320 people
- Sponsor
- Ascendis Pharma Oncology Division A/S
Breast Cancer, HER2-positive Breast Cancer
Kadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease
This is a Phase 2 study for patients with resected Stage I-III HER2+ breast cancer with detected molecular residual disease (MRD+) following standard neoadjuvant and locoregional therapy delivered with curative intent.
- Trial name
- NCT05388149
- Testing
- Neratinib
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- University Health Network, Toronto
Esophageal Cancer, Gastric Adenocarcinoma
A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer
The purpose of this study to find out whether adding trastuzumab and pembrolizumab to standard chemotherapy is an effective treatment for resectable HER2+ esophagogastric cancer.
- Conditions
- Esophageal Cancer, Gastric Adenocarcinoma, HER2 Gene Mutation
- Trial name
- NCT06123338
- Testing
- Pembrolizumab, Trastuzumab, Oxaliplatin
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Neoplasms, Triple Negative Breast Neoplasms
A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
Researchers are looking for new ways to treat types of breast cancer that are both: High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment Early-stage, which means the cancer is…
- Conditions
- Breast Neoplasms, Triple Negative Breast Neoplasms, HR Low-Positive/HER2-Negative Breast Neoplasms
- Trial name
- NCT06966700
- Testing
- Sacituzumab tirumotecan, Pembrolizumab, Rescue Medication
- Where
- 331 sites in United States, Argentina and 39 more
- Volunteers
- 2,400 people
- Sponsor
- Merck Sharp & Dohme LLC
HER2-positive Advanced Breast Cancer, Brain Metastases
Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases
A total of 224 subjects of HER2-positive advanced breast cancer with brain metastases are planned to be enrolled. Eligible subjects will be randomly assigned in a 1:1 ratio to the group receiving Trastuzumab Rezetecan combined…
- Conditions
- HER2-positive Advanced Breast Cancer, Brain Metastases, Radiotherapy
- Trial name
- NCT07100600
- Testing
- Trastuzumab Rezetecan, FSRT or WBRT
- Where
- China
- Volunteers
- 224 people
- Sponsor
- Henan Cancer Hospital
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Positive Breast Carcinoma
Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis
This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Positive Breast Carcinoma, Oligometastatic Breast Carcinoma
- Trial name
- NCT07578116
- Testing
- Biopsy Procedure, Biospecimen Collection, Breast Conservation Treatment
- Where
- 59 sites in United States
- Volunteers
- 562 people
- Sponsor
- SWOG Cancer Research Network
Carcinoma Breast Stage I, HER2 Positive Breast Cancer
Pre Operative Trastuzumab in Operable Breast Cancer
Background Information and Rationale: Trastuzumab is a humanized monoclonal antibody that acts extracellularly on the erbB-2 receptor.Trastuzumab is a recombinant humanized IgG1 monoclonal antibody against the human epidermal…
- Trial name
- NCT01785420
- Testing
- Trastuzumab
- Where
- India
- Volunteers
- 1,100 people
- Sponsor
- Dr Rajendra A. Badwe
Advanced Breast Carcinoma, HER2-Positive Breast Carcinoma
TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer
This phase II trial studies how well FASN inhibitor TVB-2640, paclitaxel, and trastuzumab work in treating patients with HER2 positive breast cancer that has spread to other places in the body (metastatic).
- Conditions
- Advanced Breast Carcinoma, HER2-Positive Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
- Trial name
- NCT03179904
- Testing
- Anastrozole, Denifanstat, Exemestane
- Where
- 3 sites in United States
- Volunteers
- 17 people
- Sponsor
- Mayo Clinic
Invasive Breast Cancer, Inflammatory Breast Cancer Stage III
TRUDI: TDXD+Durva in HER2+/Low IBC
The purpose of this study is to test the safety and effectiveness of an investigational drug combination (trastuzumab deruxtecan and durvalumab) to learn whether the intervention works in treating Human Epidermal growth factor…
- Conditions
- Invasive Breast Cancer, Inflammatory Breast Cancer Stage III, HER2-positive Breast Cancer, HER2 Low Breast Adenocarcinoma
- Trial name
- TRUDI (NCT05795101)
- Testing
- Trastuzumab deruxtecan, Durvalumab
- Where
- 3 sites in United States
- Volunteers
- 63 people
- Sponsor
- Filipa Lynce, MD