Clinical trials: Metastatic HER2-positive Breast Cancer With Brain Metastasis, open to volunteers
Breast Cancer, Brain Metastases
A Two-cohort Study of SHR-A1811 in the Treatment of HER2-positive Breast Cancer With Brain Metastases
This is a multi-center, open-label, two-cohort study. The purpose of this study is to evaluate the safety, tolerability and efficacy of SHR-A1811 in the treatment of HER2-positive breast cancer with brain and leptomeningeal…
- Conditions
- Breast Cancer, Brain Metastases, Leptomeningeal Metastasis
- Trial name
- NCT07177950
- Testing
- SHR-A1811, radiotherapy
- Volunteers
- 51 people
- Sponsor
- Peking University Cancer Hospital & Institute
Brain Metastases, HR+ Metastatic Breast Cancer
SRS & Abemaciclib w/wo Imlunestrant in the Management of HR+/HER2- Breast CA Brain Metastases
This is a single arm study of abemaciclib and endocrine therapy with stereotactic radiosurgery (SRS) among patients with hormone receptor (HR)+/HER2- metastatic breast cancer brain metastases.
- Trial name
- NCT04923542
- Testing
- Stereotactic Radiosurgery (SRS), Abemaciclib, Endocrine therapy
- Where
- 2 sites in United States
- Volunteers
- 31 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Metastatic Breast Cancer in the Brain
Efficacy of Pyrotinib Plus Capecitabine in HER2-positive MBC With Active Brain Metastases That Have Failed ADCs
To evaluate the efficacy and safety of pyrotinib plus capecitabine in HER2-positive breast cancer patients with active brain metastases that have failed ADCs
- Trial name
- NCT06475443
- Testing
- pyrotinib plus capecitabine
- Volunteers
- 32 people
- Sponsor
- Henan Cancer Hospital
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
Breast Cancer With Brain Metastasis, HER2-positive Breast Cancer
T-DXd With or Without Neratinib for HER2 Positive Breast Cancer With Brain Metastasis
A phase II, open-label, multicenter, randomized controlled trial exploring the efficacy and safety of Trastuzumab Deruxtecan combined with or without Neratinib in HER2-positive breast cancer with brain metastasis
- Trial name
- THUNDER (NCT07152782)
- Testing
- Neratinib, Trastuzumab Deruxtecan
- Where
- China
- Volunteers
- 202 people
- Sponsor
- Fudan University
HER2-positive Breast Cancer, LMD
Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+, HER2 Mutated and/or HER2-amplified Metastatic Breast Cancer and Leptomeningeal Disease: A Multi-centre Phase II, Single Arm Feasibility Study
The proposed study will evaluate the safety and efficacy of XRT followed by systemic therapy among patients with HER2+, HER2 mutated and/or HER2-amplified metastatic breast cancer and LMD
- Trial name
- NCT06016387
- Testing
- Tucatinib 150 MG, Trastuzumab, Capecitabine
- Where
- 2 sites in Canada
- Volunteers
- 30 people
- Sponsor
- Sunnybrook Health Sciences Centre
HR-positive, HER2-negative Metastatic Breast Cancer With Brain Metastases
Culmerciclib Plus Anlotinib and Endocrine Therapy for HR-Positive/HER2-Negative Metastatic Breast Cancer With Brain Metastases
This study aims to evaluate the efficacy and safety of adding the anti-angiogenic agent anlotinib to the combination of the CDK2/4/6 inhibitor Culmerciclib and endocrine therapy in patients with HR+/HER2- breast cancer and brain…
- Trial name
- NCT07745257
- Testing
- Culmerciclib, Anlotinib, Endocrine Therapy
- Where
- 9 sites in China
- Volunteers
- 40 people
- Sponsor
- Sun Yat-sen University
Breast Neoplasms, Brain Neoplasms
Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth…
- Conditions
- Breast Neoplasms, Brain Neoplasms, Neoplasms by Site, Neoplasms
- Trial name
- ELECTRA (NCT05386108)
- Testing
- Elacestrant, Abemaciclib
- Where
- 86 sites in United States, Belgium and 8 more
- Volunteers
- 73 people
- Sponsor
- Stemline Therapeutics, Inc.
Breast Cancer Metastatic
A Phase II Study of SHR-A1811 Combined With Radiotherapy in HER2-positive and HER2-low Breast Cancer Brain Metastases
A prospective, single-arm study to explore the efficacy and safety of SHR-A1811 combined with radiotherapy in patients with HER2-positive or HER2-low brain metastases
- Trial name
- NCT06975462
- Testing
- SHR-A1811 and radiotherapy
- Volunteers
- 30 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Malignant Neoplasm in the Brain
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
This phase IIa trial studies how well dendritic cell vaccines against Her2/Her3 and pembrolizumab work for the treatment of triple negative breast cancer or HER2+ breast cancer or HER+ Breast cancer that has spread to the brain…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Malignant Neoplasm in the Brain, Metastatic Triple-Negative Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8
- Trial name
- NCT04348747
- Testing
- Anti-HER2/HER3 Dendritic Cell Vaccine, Pembrolizumab
- Where
- 3 sites in United States
- Volunteers
- 23 people
- Sponsor
- Roswell Park Cancer Institute
HER2-positive Breast Cancer
Identification of Risk Factors for Brain Recurrence in Patients With HER2-positive Localised Breast Cancer
HER2 gene amplification, detected in 20% to 30% of breast cancers, was a poor prognostic factor before the advent of anti-HER2 therapies.
- Trial name
- CRANIUM (NCT06358625)
- Testing
- Pre-treatment biopsy
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Center Eugene Marquis
Breast Cancer (Advanced/Metastatic)
Study of Trastuzumab Deruxtecan in Combination With Stereotactic Radiosurgery in Patients With HER2-Positive Metastatic Breast Cancer and First Diagnosis of Brain Metastases (HERBRAIN)
This is a Phase II, single-arm, Bayesian adaptive trial. The study employs a two-stage design with an interim analysis after 30 evaluable patients and a maximum enrolment of 60 patients.
- Trial name
- HERBRAIN (NCT07905313)
- Testing
- SRS/fSRT+T-Dxd
- Volunteers
- 60 people
- Sponsor
- Azienda Ospedaliero-Universitaria Careggi
Breast Cancer
Efficacy and Safety of Disitamab Vedotin Plus Pyrotinib or Naratinib in HER2-positive Breast Cancer Patients With Brain Metastasis
Basis: Brain metastasis is very common in breast cancer, and HER2 positivity is a risk factor for high incidence of brain metastasis, with approximately 50% of HER2+ MBC cases experiencing brain metastasis.
- Trial name
- NCT06015113
- Testing
- Disitamab Vedotin plus pyrotinib or naratinib
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Xi'an International Medical Center Hospital
HER2-positive Breast Cancer
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
The purpose of this study is to assess the efficacy and safety of RO7771950 in combination with trastuzumab and capecitabine, compared to tucatinib in combination with trastuzumab and capecitabine.
- Trial name
- BREnnA (NCT07413939)
- Testing
- RO7771950, Tucatinib, Trastuzumab
- Where
- 219 sites in United States, Argentina and 24 more
- Volunteers
- 650 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, HER2-positive Breast Cancer
Trastuzumab Deruxtecan + Stereotactic Radiosurgery (SRS) in HER2+ Breast Cancer Brain Metastases
A phase I clinical trial (a type of research study) for people with human epidermal growth factor receptor 2 (HER-2) positive breast cancer with metastasis to the brain.
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Brain Metastases, Cancer
- Trial name
- NCT07454668
- Testing
- Trastuzumab Deruxtecan, Stereotactic Radiosurgery
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Baptist Health South Florida
Breast Cancer, Metastatic Breast Cancer
Heterogeneity of 68Ga-FAPI Uptake As Imaging Biomarker in T-DXd Treatment for Brain Metastasis of HER2 Positive Breast Cancer
The purpose of this study was to explore the predictive value of the heterogeneity of 68Ga-FAPI PET-CT uptake before treatment on the response of T-DXd treatment in patients with brain metastases of HER2-positive breast cancer.
- Trial name
- NCT06797622
- Testing
- Trastuzumab deruxtecan (T-DXd)
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Fudan University