Clinical trials: Her2 Positive Metastatic Breast Cancer
HER2-positive Breast Cancer
B003 in Patients With HER2-positive Recurrent or Metastatic Breast Cancer
To assess the safety and tolerability characteristics of B003 in HER2-positive patients with recurrent or metastatic breast cancer. The dose-limiting toxicity (DLT) is assessed and the maximum tolerated dose (MTD) is explored.
- Trial name
- B003-101 (NCT03953833)
- Testing
- Recombinant anti-HER2 humanized monoclonal antibody conjugate for injection.R&D code: B003.
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
ER-Positive, HER2-Negative Breast Cancer
A Phase 1 Study of HRS8807 Monotherapy and in Combination With SHR6390 in Subjects With ER-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer
The study is to assess safety and tolerability of HRS8807 monotherapy and in combination with SHR6390 in subjects with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum…
- Trial name
- NCT04993430
- Testing
- HRS8807, HRS8807、SHR6390
- Where
- China
- Volunteers
- 46 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Breast Neoplasms
Sapanisertib in Combination With Fulvestrant in Women With Advanced or Metastatic Breast Cancer After Aromatase Inhibitor Therapy
The primary purpose of this study is to compare the progression free survival (PFS) of participants treated with the combination of fulvestrant plus daily sapanisertib and fulvestrant plus weekly sapanisertib versus participants…
- Trial name
- NCT02756364
- Testing
- Fulvestrant, Sapanisertib
- Where
- 53 sites in United States, Spain
- Volunteers
- 141 people
- Sponsor
- Calithera Biosciences, Inc
Breast Cancer
RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
This is a retrospective, observational study that will document treatment patterns and clinical outcomes of postmenopausal patients diagnosed with HR+/HER2- mBC who received Palbociclib plus Letrozole as initial endocrine-based…
- Trial name
- NCT04460898
- Where
- United States
- Volunteers
- 195 people
- Sponsor
- Pfizer
Breast Cancer
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2…
- Trial name
- NCT06757634
- Testing
- Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole
- Where
- 239 sites in United States, Argentina and 23 more
- Volunteers
- 1,180 people
- Sponsor
- Celcuity Inc
Breast Cancer, Stage IV Breast Cancer
Positron Emission Tomography in Women With Advanced HER2-Positive Breast Cancer
RATIONALE: Diagnostic procedures, such as copper Cu 64-DOTA-trastuzumab-labeled PET, may help doctors to plan a better treatment PURPOSE: This pilot trial is studying copper Cu 64-tetra-azacyclododecanetetra-acetic acid…
- Trial name
- NCT01093612
- Testing
- positron emission tomography, copper Cu 64-DOTA-trastuzumab, Biopsy
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- City of Hope Medical Center
HER2-positive, Metastatic Breast Cancer
ARX788 in HER2-positive Metastatic Breast Cancer Patients
A phase 2 study of ARX788 given every 6 weeks in HER2-positive, metastatic breast cancer patients.
- Trial name
- NCT06663748
- Testing
- ARX788
- Where
- China
- Volunteers
- 44 people
- Sponsor
- Henan Cancer Hospital
Breast Cancer
A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.
The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer.
- Trial name
- NCT06307457
- Testing
- Palbociclib in combination with AI
- Where
- Denmark
- Volunteers
- 604 people
- Sponsor
- Pfizer
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing the Addition of an Investigational Anti-Cancer Drug, ASTX660 (Tolinapant), to a Usual Chemotherapy Treatment (Eribulin) for Treatment of Advanced Triple Negative Breast Cancer
This phase I/Ib trial tests the safety, side effects, best dose, and effectiveness of ASTX660 (tolinapant) in combination with eribulin mesylate (eribulin) in treating patients with triple negative breast cancer that cannot be…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Locally Advanced HER2-Negative Breast Carcinoma
- Trial name
- NCT06590558
- Testing
- Biopsy Procedure, Biospecimen Collection, Computed Tomography
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Open Label Trial of INCB07839 to Determine Effect and Safety of INCB007839 Plus Trastuzumab in HER2 Positive Metastatic Breast Cancer
This is a single arm, modified dose escalation, open label trial with the objectives of: (1) Determining a safe optimal dose of INCB007839 in combination with trastuzumab and docetaxel (2) Determining clinical efficacy and safety…
- Trial name
- NCT00864175
- Testing
- INCB007839, trastuzumab, Docetaxel
- Where
- 12 sites in India
- Volunteers
- 68 people
- Sponsor
- Incyte Corporation
Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC)
JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer
This is a multicenter, open-label, Phase Ib/II randomized study designed to evaluate the safety, tolerability, dose-limiting toxicities (DLTs), and preliminary antitumor activity of JSKN016 in combination with the oral selective…
- Trial name
- NCT07336771
- Testing
- JSKN016 Q2W, JSKN016 Q3W, D-0502
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Metastatic Breast Cancer, Advanced Breast Cancer
Margetuximab Plus Tucatinib and Capecitabine in HER2-positive Metastatic Breast Cancer
This is a multicenter, open-label, single-arm, phase II clinical trial to evaluate the efficacy and safety of margetuximab in combination with tucatinib and capecitabine in patients with human epidermal growth factor receptor 2…
- Conditions
- Metastatic Breast Cancer, Advanced Breast Cancer, HER2-positive Breast Cancer
- Trial name
- MARGARET (NCT05227131)
- Testing
- Margetuximab, Tucatinib, Capecitabine
- Sponsor
- MedSIR
Metastatic Breast Cancer
A Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Immunogenicity of Test Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,)
The purpose of this study is to compare the efficacy, safety, pharmacokinetic, and immunogenicity of Pertuzumab (Test, Cadila Healthcare Ltd.,) plus Trastuzumab and Docetaxel versus Pertuzumab (Reference, Genentech Inc.,) plus…
- Trial name
- NCT05283837
- Testing
- Pertuzumab (ZRC-3277), Pertuzumab (Perjeta®)
- Where
- India
- Volunteers
- 268 people
- Sponsor
- Zydus Lifesciences Limited
Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer
Phase II Study of Everolimus Beyond Progression
This phase II trial studies how well everolimus and hormone therapy work in treating patients with hormone receptor positive breast cancer that has continued to spread (progressed) or returned after a period of improvement…
- Conditions
- Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Progesterone Receptor-positive Breast Cancer, Recurrent Breast Cancer
- Trial name
- NCT02269670
- Testing
- everolimus, anastrozole, letrozole
- Where
- 3 sites in United States
- Volunteers
- 3 people
- Sponsor
- Emory University
Breast Cancer
Study to Evaluate Safety and Dosimetry of [18F]GEH121224 in Patients With Locally Advanced or Metastatic Breast Cancer
The study described in this protocol is a Phase 1, single center clinical trial to evaluate the safety and potential of [18F]GEH121224 as a PET radiotracer for the diagnostic imaging of HER2 positive breast cancer lesions.
- Trial name
- NCT05634954
- Testing
- GEH121224 (18F) Injection, Dynamic and Static - PET/CT Scan, Static - PET/CT Scan
- Where
- United States
- Sponsor
- GE Healthcare
Cardiotoxicity, HER2/Neu Positive
S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity
This trial has two cohorts of patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. All patients must be receiving trastuzumab-based treatment.
- Conditions
- Cardiotoxicity, HER2/Neu Positive, Metastatic Malignant Neoplasm in the Brain, Recurrent Breast Carcinoma
- Trial name
- NCT03418961
- Testing
- Carvedilol, Laboratory Biomarker Analysis, Patient Observation
- Where
- 590 sites in United States, Puerto Rico and 2 more
- Volunteers
- 491 people
- Sponsor
- SWOG Cancer Research Network
Metastatic Breast Cancer
Famitinib Plus SHR6390 and Endocrine Therapy in the Treatment of HR-positive, HER2-negative Advanced Breast Cancer
The main purpose of this study was to evaluate the efficacy and safety of treatment with famitinib plus SHR6390 and endocrine therapy for hormone receptor (HR)-positive, Human Epidermal Growth Factor Receptor (HER) 2 - negative…
- Trial name
- NCT05176080
- Testing
- Famitinib, SHR6390, Fulvestrant
- Where
- China
- Volunteers
- 46 people
- Sponsor
- Henan Cancer Hospital
Breast Cancer
Tucidinostat Combined With Metronomic Capecitabine and Endocrine Therapy for Advanced HR-positive, HER2-negative Breast Cancer After CDK4/6 Inhibitor.
The study is designed to explore the clinical benefit following treatment with tucidinosta in combination with metronomic capecitabine and endocrine therapy in patients with hormone receptor-positive, Her2-negative advanced…
- Trial name
- NCT05411380
- Testing
- Tucidinostat, Capecitabine, Endocrine Therapy
- Where
- China
- Volunteers
- 73 people
- Sponsor
- wang shusen
Breast Cancer
A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer
The researcher are doing this study to find out whether benralizumab is effective at preventing skin rashes caused by alpelisib in people who have metastatic breast cancer. Skin rash is a common side effect of alpelisib.
- Trial name
- NCT05966584
- Testing
- Benralizumab, fulvestrant or AIs) and PI3K inhibition (alpelisib)
- Where
- 7 sites in United States
- Volunteers
- 1 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer, Metastatic HER2-negative Breast
T-Cell Therapy for Advanced Breast Cancer
The purpose of this study is to test the safety of different doses of specially prepared T cells collected from the blood. The investigators want to find a safe dose of these modified T cells for patients who have metastatic…
- Trial name
- NCT02792114
- Testing
- Cyclophosphamide, Mesothelin-targeted T cells, AP1903
- Where
- 7 sites in United States
- Volunteers
- 186 people
- Sponsor
- Memorial Sloan Kettering Cancer Center