Clinical trials: Metastatic HER2-positive Breast Cancer With Brain Metastasis
Malignant Neoplasm, Metastatic Malignant Neoplasm in the Brain
HER2-CAR T Cells in Treating Patients With Recurrent Brain or Leptomeningeal Metastases
This phase I trial studies the side effects and best dose of HER2-CAR T cells in treating patients with cancer that has spread to the brain or leptomeninges and has come back (recurrent).
- Conditions
- Malignant Neoplasm, Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Neoplasm in the Leptomeninges, Breast Cancer
- Trial name
- NCT03696030
- Testing
- Chimeric Antigen Receptor T-Cell Therapy
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- City of Hope Medical Center
Breast Carcinoma Metastatic in the Brain, Estrogen Receptor Negative
Palbociclib in Treating Patients With Metastatic HER-2 Positive Breast Cancer With Brain Metastasis
The purpose of this study is to evaluate if the study drug palbociclib has anti-tumor activity against the breast cancer that has spread to the brain and also to determine the overall radiographic response rate in the CNS.
- Conditions
- Breast Carcinoma Metastatic in the Brain, Estrogen Receptor Negative, HER2/Neu Negative, HER2/Neu Positive
- Trial name
- NCT02774681
- Testing
- Cognitive Assessment, Palbociclib, Quality-of-Life Assessment
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Northwestern University
Metastatic Breast Cancer
A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer
DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer
- Trial name
- DB-07 (NCT04538742)
- Testing
- Trastuzumab deruxtecan, Durvalumab, Paclitaxel
- Where
- 72 sites in United States, Australia and 13 more
- Volunteers
- 245 people
- Sponsor
- AstraZeneca
Breast Cancer, Brain Tumor - Metastatic
Cabozantinib +/- Trastuzumab In Breast Cancer Patients w/ Brain Metastases
This research study is evaluating the effectiveness of the drug called cabozantinib (alone or in combination with trastuzumab) as a possible treatment for advanced breast cancer in which the cancer has spread to the brain.
- Trial name
- NCT02260531
- Testing
- Cabozantinib, Trastuzumab
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer, Brain Metastases
Palbociclib, Trastuzumab,Pyrotinib and Fulvestrant Treatment in Patients With Brain Metastasis From ER/PR Positive, HER-2 Positive Breast Cancer: A Multi-center, Prospective Study in China
The objective of this study is to evaluate the efficacy of combination of palbociclib, trastuzumab and pyrotinib with fulvestrant in ER/PR positive and HER2-positive breast cancer patients with brain metastasis.
- Trial name
- NCT04334330
- Testing
- Palbociclib, Trastuzumab, Pyrotinib and Fulvestrant
- Where
- 2 sites in China
- Volunteers
- 34 people
- Sponsor
- Sun Yat-sen University
Brain Metastases, Human Epidermal Growth Factor 2 Positive Carcinoma of Breast
Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib
Patients with advanced HER2+ breast cancer on maintenance trastuzumab/pertuzumab or T-DM1 with 1st or 2nd intracranial disease event (brain metastases) and stable extracranial disease will be enrolled.
- Conditions
- Brain Metastases, Human Epidermal Growth Factor 2 Positive Carcinoma of Breast, Advanced Breast Cancer
- Trial name
- BRIDGET (NCT05323955)
- Testing
- Trastuzumab, Trastuzumab Emtansine (T-DM1), Pertuzumab
- Where
- 8 sites in United States
- Volunteers
- 48 people
- Sponsor
- Carey Anders, M.D.
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 Cancer
Lapatinib Ditosylate and Capecitabine in Treating Patients With Stage IV Breast Cancer and Brain Metastases
RATIONALE: Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
- Trial name
- NCT00967031
- Testing
- capecitabine, lapatinib ditosylate, circulating tumor cell analysis
- Where
- France
- Volunteers
- 45 people
- Sponsor
- UNICANCER
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
Breast Neoplasm, Brain Metastases
MRI Screening Versus SYMptom-directed Surveillance for Brain Metastases Among Patients with Triple Negative or HER2+ MBC
In this study, 50 women with either HER2+ or triple negative metastatic breast cancer but no known brain metastases will be recruited at the Sunnybrook Odette Cancer Centre.
- Conditions
- Breast Neoplasm, Brain Metastases, Triple Negative Breast Cancer, HER2-positive Breast Cancer
- Trial name
- SYMPToM (NCT03881605)
- Testing
- MRI screening
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Sunnybrook Health Sciences Centre
Advanced Breast Cancer, HER2-positive Breast Cancer
DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease
This is a multicenter, international, open-label, single-arm, multicohort, two-stage optimal Simon's design, phase II clinical trial
- Conditions
- Advanced Breast Cancer, HER2-positive Breast Cancer, Brain Metastases, Leptomeningeal Metastasis
- Trial name
- DEBBRAH (NCT04420598)
- Testing
- Trastuzumab deruxtecan
- Where
- 16 sites in Portugal, Spain
- Volunteers
- 41 people
- Sponsor
- MedSIR
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
Breast Cancer
A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer
This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic…
- Trial name
- DESTINY-B12 (NCT04739761)
- Testing
- Trastuzumab Deruxtecan
- Where
- 81 sites in United States, Australia and 16 more
- Volunteers
- 506 people
- Sponsor
- AstraZeneca
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
HER-2 Positive Breast Cancer, Metastatic Malignant Neoplasm to Brain
Study of the Combination of KD019 and Trastuzumab in Subjects With HER2-Positive Metastatic Breast Cancer
Evaluate the safety and tolerability and determine the maximum tolerated dose (MTD) of the combination of tesevatinib and trastuzumab in subjects with HER2-positive metastatic breast cancer
- Trial name
- NCT02154529
- Testing
- Tesevatinib, Trastuzumab
- Where
- 6 sites in United States
- Volunteers
- 17 people
- Sponsor
- Kadmon Corporation, LLC
Breast Cancer, HER2-positive Breast Cancer
Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
This research study is studying the usefulness of magnetic resonance imaging (MRI) to screen for brain metastases (spread of the breast cancer to the brain).
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast
- Trial name
- NCT04030507
- Testing
- MRI
- Where
- United States
- Volunteers
- 214 people
- Sponsor
- Brigham and Women's Hospital
Metastatic Breast Cancer With a Isolated Brain Progression
Treatment With Tucatinib in Patients With an Isolated Brain Progression of a Metastatic Breast Cancer
The overall survival of patients with metastatic breast cancer has steadily improved over the past decades, mainly due to advances in systemic treatment.
- Trial name
- InTTercePT (NCT05041842)
- Testing
- Tucatinib, Pertuzumab, Trastuzumab
- Where
- 16 sites in France
- Volunteers
- 53 people
- Sponsor
- UNICANCER