Clinical trials: HER2 Positive Metastatic Breast Cancer
Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with…
- Trial name
- NCT05306340
- Testing
- Giredestrant, Exemestane, Fulvestrant
- Where
- 136 sites in United States, Argentina and 11 more
- Volunteers
- 373 people
- Sponsor
- Genentech, Inc.
Advanced Solid Tumor, Metastatic Solid Tumor
BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
This is an open-label, multicenter, phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-43395, a cyclin-dependent kinase 4 (CDK4)…
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Hormone-receptor-positive Breast Cancer, Breast Cancer
- Trial name
- NCT06253195
- Testing
- BGB-43395, Fulvestrant, Letrozole
- Where
- 7 sites in China
- Volunteers
- 33 people
- Sponsor
- BeOne Medicines
Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer
ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
This is a multicenter, open-label, non-controlled, phase I study to investigate the tolerability and safety of ONO-4578 used in combination with standard-of-care letrozole and a CDK4/6 inhibitor (palbociclib or Abemaciclib) as…
- Conditions
- Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Trial name
- NCT06570031
- Testing
- ONO-4578, letrozole, Palbociclib
- Where
- 13 sites in Japan
- Volunteers
- 46 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
HER2-negative Breast Cancer, Hormone-receptor-positive Breast Cancer
DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Breast Cancer Patients
This study is being done to determine if there is a pattern associated with response to endocrine therapy alone and in combination with CDK4/6 inhibitor used for hormone receptor positive HER2 negative breast cancer.
- Conditions
- HER2-negative Breast Cancer, Hormone-receptor-positive Breast Cancer, Metastatic Breast Cancer, Anatomic Stage II Breast Cancer AJCC v8
- Trial name
- NCT06388122
- Testing
- Biospecimen Collection
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Mayo Clinic
Metastatic Breast Adenocarcinoma, Metastatic HER2-Positive Breast Carcinoma
Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer
This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic).
- Conditions
- Metastatic Breast Adenocarcinoma, Metastatic HER2-Positive Breast Carcinoma, Recurrent Breast Adenocarcinoma, Recurrent HER2-Positive Breast Carcinoma
- Trial name
- NCT03199885
- Testing
- Atezolizumab, Biopsy, Bone Scan
- Where
- 673 sites in United States, Canada
- Volunteers
- 190 people
- Sponsor
- National Cancer Institute (NCI)
Metastatic Breast Cancer, Stage IV Breast Cancer
A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer
The purpose of this study is to test different doses of abemaciclib to find the best dose in participants while receiving hormone therapy and radiation therapy.
- Conditions
- Metastatic Breast Cancer, Stage IV Breast Cancer, Breast Cancer, Breast Cancer Stage IV
- Trial name
- NCT06678269
- Testing
- Abemaciclib, Radiation Therapy
- Where
- 7 sites in United States
- Volunteers
- 28 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer Metastatic, Locally Advanced Breast Cancer (LABC)
A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer
The goal of this clinical trial is to evaluate CLBR001 and ABBV-461 as a treatment for patients with locally advanced or metastatic breast cancer.
- Conditions
- Breast Cancer Metastatic, Locally Advanced Breast Cancer (LABC), Malignant Neoplasm of Breast, Triple Negative Breast Cancer (TNBC)
- Trial name
- NCT06878248
- Testing
- Two Component Product CLBR001 + ABBV-461
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- Calibr, a division of Scripps Research
Advanced/Metastatic Breast Cancer, HER2-Positive Metastatic Breast Cancer
Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer
Efficacy and Safety of Dalpiciclib Combined with Anti-HER2 Targeted Therapy and Endocrine Therapy as First-line Maintenance Treatment for Patients with Recurrent or Metastatic Hormone-Receptor-Positive, HER2-positive Breast…
- Trial name
- NCT07610720
- Testing
- Dalpiciclib, Trastuzumab (Herceptin), Pertuzumab
- Where
- China
- Volunteers
- 57 people
- Sponsor
- Sun Yat-sen University
Breast Cancer, Metastatic Breast Cancer
89Zr-DFO*-Trastuzumab PET in Patients With Gastric or Breast Cancer - a Pilot Study
The goal of this clinical trial is to test a new PET tracer in patients with HER2-positive breast or gastric cancer. This tracer is made of radioactively labeled trastuzumab, and can show where HER2 is present in the body using a…
- Conditions
- Breast Cancer, Metastatic Breast Cancer, HER2-positive Breast Cancer, Gastric Cancer
- Trial name
- HER Image (NCT05955833)
- Testing
- 89Zr-DFO*-trastuzumab PET scan
- Where
- Netherlands
- Volunteers
- 6 people
- Sponsor
- Amsterdam UMC, location VUmc
Metastatic Breast Cancer, HER2-positive Breast Cancer
A Study of Surgery and Radiotherapy in People With Breast Cancer
The researchers are doing this study to see if the combination of surgery, locoregional radiation therapy, SBRT (stereotactic body radiation therapy), and the usual approach is more effective in treating oligometastatic…
- Trial name
- NCT07053085
- Testing
- Lumpectomy or mastectomy, Radiotherapy, Trastuzumab, Pertuzumab, Paclitaxel, or a combination of these drugs
- Where
- 7 sites in United States
- Volunteers
- 178 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer
This phase Ib/II trial studies the side effects and best dose of ribociclib, tucatinib, and trastuzumab for the treatment of HER2 positive breast cancer that has spread to other parts of the body (metastatic), and then compares…
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Trial name
- NCT05319873
- Testing
- Carboplatin, Docetaxel, Fulvestrant
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Jonsson Comprehensive Cancer Center
HER2-positive Recurrent or Metastatic Breast Cancer
A Study of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line Treatment for HER2-Positive Recurrent or Metastatic Breast Cancer
This study is a randomized, controlled, open-label, multicenter, phase II superiority clinical trial. The planned study population consists of participants with HER2-positive recurrent or metastatic breast cancer who have not…
- Trial name
- NCT07545044
- Testing
- JSKN003, Trastuzumab, Pertuzumab
- Volunteers
- 60 people
- Sponsor
- Shanghai JMT-Bio Inc.
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma
A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer
This phase II trial studies how well a vaccine, STEMVAC, works in combination with standard endocrine-based therapy (ET) with a CDK4/6 targeted drug therapy, or with the chemotherapy drug capecitabine, in treating patients with…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma
- Trial name
- NCT07112053
- Testing
- CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine, Capecitabine, Computed Tomography
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Washington
Breast Cancer (Advanced/Metastatic), HER2-positive Breast Cancer
Dual-Target CAR-NK Cells for Advanced Breast Cancer HER2+ TNBC
This study tests the safety and preliminary anti-tumor activity of an investigational dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy in adults with advanced breast cancer.
- Conditions
- Breast Cancer (Advanced/Metastatic), HER2-positive Breast Cancer, Triple-negative Breast Cancer
- Trial name
- NCT07510802
- Testing
- Dual-target CAR-NK cells, Lymphodepleting, Supportive care
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Beijing Biotech
Breast Cancer, HER2-Positive Metastatic Breast Cancer
SURVEY-CNS: A Feasibility Study of Randomising Women and Men With HER2-Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus No Surveillance
SURVEY-CNS is a feasibility study evaluating whether women and men with HER2-positive metastatic breast cancer can be successfully recruited and randomised to a strategy of central nervous system (CNS) magnetic resonance imaging…
- Trial name
- SURVEY-CNS (NCT07503717)
- Testing
- Brain Magnetic Resonance Imaging (MRI) with Contrast
- Where
- Ireland
- Volunteers
- 69 people
- Sponsor
- Royal College of Surgeons, Ireland
Breast Cancer (Locally Advanced or Metastatic), HER2-positive Breast Cancer
Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC)
This study tests the safety and preliminary anti-tumor activity of an investigational dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy in adults with advanced breast cancer.
- Conditions
- Breast Cancer (Locally Advanced or Metastatic), HER2-positive Breast Cancer, Triple-Negative Breast Cancer (TNBC)
- Trial name
- DUAL-NK-BC (NCT07486089)
- Testing
- Dual-target CAR-NK cells (EB-DT-CAR-NK), Lymphodepleting chemotherapy, Supportive care
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Beijing Biotech
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
ALRN-6924 and Paclitaxel in Treating Patients With Advanced, Metastatic, or Unresectable Solid Tumors
This phase Ib trial studies the side effects and best dose of ALRN-6924 when given together with paclitaxel in treating patients with solid tumors that have spread to other places in the body or cannot be removed by surgery.
- Conditions
- Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8
- Trial name
- NCT03725436
- Testing
- MDM2/MDMX Inhibitor ALRN-6924, Paclitaxel
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- M.D. Anderson Cancer Center
HER2-positive Metastatic Breast Cancer
Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.
Phase IB/II clinical trial of Alpelisb and Tucatinib in patients with PIK3CA-Mutant HER2-positive metastatic breast cancer.
- Trial name
- NCT05230810
- Testing
- Alpelisib, Tucatinib, Fulvestrant
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Criterium, Inc.
HER2 Positive Metastatic Breast Cancer
ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)
A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd
- Trial name
- NCT04829604
- Testing
- ARX788
- Where
- 33 sites in United States, Australia and 1 more
- Volunteers
- 72 people
- Sponsor
- Ambrx, Inc.
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma
Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer (A ComboMATCH Treatment Trial)
This phase II ComboMATCH treatment trial compares the usual treatment alone (fulvestrant) to using binimetinib plus the usual treatment in patients with hormone receptor positive breast cancer that has spread from where it first…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma
- Trial name
- NCT05554354
- Testing
- Binimetinib, Biopsy Procedure, Biospecimen Collection
- Where
- 196 sites in United States, Puerto Rico
- Volunteers
- 1 people
- Sponsor
- National Cancer Institute (NCI)