Clinical trials: HER2 Positive Breast Cancer, open to volunteers
Breast Cancer
Molecular Analyses to Predict Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer
This is an exploratory phase II interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for 4-12 weeks (+/- 2 weeks).
- Trial name
- MAPPER (NCT06361940)
- Testing
- Aromatase inhibitors or tamoxifen
- Where
- United States
- Volunteers
- 185 people
- Sponsor
- Medical College of Wisconsin
Breast Cancer
Clinical Study of SHR-A1811 With or Without Letrozole in Neoadjuvant Therapy for Early-Stage HR-Positive, HER2-Low Breast Cancer
This is a prospective, randomized, multi-cohort, Phase II clinical trial. The study plans to enroll 120 patients with early-stage or locally advanced, HR-positive, HER2-low breast cancer.
- Trial name
- NCT07305246
- Testing
- SHR-A1811, Letrozole, TAC/AC-T
- Volunteers
- 120 people
- Sponsor
- First Hospital of China Medical University
HER2 Positive Breast Cancer
Randomized Controlled Clinical Study of Efficacy and Safety of Initumab Combined with Pyrrotinib and Chemotherapeutic Agents in Neoadjuvant Therapy for HER2-positive Breast Cancer with Different Treatment Cycles
The purpose of this study was to explore the efficacy and safety of initumab combined with pyrrotinib and chemotherapy for 4 cycles and 6 cycles of neoadjuvant therapy for HER2-positive breast cancer, and to explore the efficacy…
- Trial name
- NCT06868017
- Testing
- Cohort A will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 4 doses, Cohort B will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 6 doses
- Volunteers
- 208 people
- Sponsor
- The First Hospital of Jilin University
Breast Cancer, Gastric Cancer (GC)
The Exploration of Novel Radionuclide-labeled HER2-targeting Antibodies in the Diagnosis of HER2-positive Malignancies
The purpose of this study is to develop and clinically evaluate 89Zr-labeled HER2-targeted antibodies in diagnosis and screening of HER2-positive cancer patients.
- Conditions
- Breast Cancer, Gastric Cancer (GC), Urothelial Carcinoma (UC)
- Trial name
- NCT07023861
- Testing
- 18F-FDG, 89Zr-LNCab190, 89Zr-LNCab002
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Affiliated Hospital of Jiangnan University
Breast Carcinoma Metastatic in Lymph Node, HER2 Positive Breast Carcinoma
Validation of TAD in HER-2 with More Than 2 Lymph Nodes
The main objective of the study is to validate the DAT technique in patients with Her2-positive breast cancer who have more than two positive axillary lymph nodes at diagnosis.
- Trial name
- DAD-HER2 (NCT06821490)
- Testing
- Targeted axillary dissection and subsequently a lymphadenectomy
- Where
- Spain
- Volunteers
- 21 people
- Sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
Advanced Solid Tumors
A Study to Evaluate ATX-898 in Participants With Advanced Solid Tumors
Study ATX-898-101 is a phase 1/2 open-label study evaluating the safety, tolerability, pharmacokinetic, and preliminary efficacy of ATX-898 as monotherapy and in combination with anti-neoplastic agents in selected solid tumors.
- Trial name
- NCT07767474
- Testing
- ATX-898, ATX-898, fulvestrant, ribociclib
- Where
- 6 sites in United States, Australia
- Volunteers
- 343 people
- Sponsor
- Antares Therapeutics, Inc
Metastatic Breast Cancer
HER2-positive Metastatic Breast Cancer in Kazakhstan
Planned study population consists of approximately 240 adult patients with HER2-positive mBC receiving anti-HER2 therapy in 12 oncological centers (in each center it is expected to recruit about 20 patients) in different regions…
- Trial name
- NCT07593196
- Where
- 12 sites in Kazakhstan
- Volunteers
- 240 people
- Sponsor
- AstraZeneca
Recurrent or Metastatic Breast Cancer
A Phase III Study of SYS6010 Versus Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer
This study is a multicenter, randomized, open-label, parallel-control Phase III clinical trial enrolling patients with unresectable HER2-negative, EGFR-positive recurrent/metastatic breast cancer who have previously failed first…
- Trial name
- NCT07406542
- Testing
- SYS6010, Investigator's Choice of Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine)
- Volunteers
- 400 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Breast Cancer, RWS
The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive
Research object：Planned to receive pyrrolidine for HER2 positive first-line breast cancer patients Research purpose: Main research objectives: To observe the efficacy and safety of pyrrolidine in the treatment of HER2 positive…
- Conditions
- Breast Cancer, RWS, Pyrotinib
- Trial name
- NCT06495541
- Testing
- Pyrotinib
- Volunteers
- 500 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Patients With HER2-positive Advanced Breast Cancer Treated With T-DXd, Patients With HER2-low Advanced Breast Cancer Treated With T-DXd
NEPA in Patients With HER2-positive or HER2-low Advanced Breast Cancer Treated With T-DXd
This clinical trial is a prospective, observational, multicenter cohort study evaluating the efficacy and safety of NEPA (netupitant/palonosetron) in patients with HER2-positive or HER2-low advanced breast cancer treated with…
- Trial name
- PRO-NEPA (NCT07132749)
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Yeon Hee Park
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
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)
Breast Neoplasms, Breast Cancer
PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan
This is a prospective non-interventional, multicenter study observing patient reported outcomes as well as real-world efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with documented Human epidermal growth factor…
- Conditions
- Breast Neoplasms, Breast Cancer, Neoplasm Metastasis
- Trial name
- PROVIDENCE (NCT05573893)
- Where
- 109 sites in Germany
- Volunteers
- 800 people
- Sponsor
- AstraZeneca
Breast Cancer, Triple Negative Breast Cancer (TNBC)
Circulating Tumor DNA Dynamics to Optimize Neoadjuvant Therapy in HER2-Positive and Triple-Negative Breast Cancer
The purpose of this non-interventional, observational study is to evaluate the clinical utility of circulating tumor DNA (ctDNA) utility-specifically how quickly tumor DNA disappears from the bloodstream (ctDNA clearance)-to help…
- Conditions
- Breast Cancer, Triple Negative Breast Cancer (TNBC), HER2 + Breast Cancer
- Trial name
- NEOSHED (NCT07662252)
- Volunteers
- 186 people
- Sponsor
- Federico II University
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
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
HER2-positive Breast Cancer
Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study
This is a phase II trial exploring the maintenance therapy with trastuzumab combined with pyrotinib or dalpiciclib and endocrine therapy in HER2-positive advanced breast cancer based on different hormone receptor (HR) statuses…
- Trial name
- NCT07179939
- Testing
- Trastuzumab rezetecan, Pyrotinib, Dalpiciclib
- Where
- China
- Volunteers
- 288 people
- Sponsor
- Fudan University
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
Locally Advanced or Metastatic Breast Cancer
Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer
This study is designed to evaluate the safety and efficacy of SPH4336 combined with letrozole in first-line treatment of locally advanced or metastatic breast cancer
- Trial name
- NCT05744687
- Testing
- SPH4336 Tablets 400mg
- Where
- 9 sites in China
- Volunteers
- 374 people
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
HR Positive/HER2 Low Breast Cancer
Neoadjuvant Therapy Combined With Trastuzumab Rezetecan and Toripalimab for HR+/HER2-low Breast Cancer (NEOTORCH-BREAST 08)
This study is a prospective, multi-cohort, multicenter, open-label exploratory clinical trial. The primary study objective is to evaluate the pathologic complete response (PCR) of treatment of HR+/HER2-low breast cancer with…
- Trial name
- NCT07383818
- Testing
- Neoadjuvant therapy combined with Trastuzumab Rezetecan and Toripalimab, Neoadjuvant Chemotherapy in Combination with Toripalimab, Neoadjuvant Chemotherapy
- Where
- 5 sites in China
- Volunteers
- 111 people
- Sponsor
- First Affiliated Hospital of Zhejiang University