Clinical trials: HER2+ Breast Cancer
Metastatic Breast Cancer
Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer
This is an open-label, multi-institution, phase Ib trial that evaluates the safety and tolerability and preliminary anti-tumor activity of fulvestrant, palbociclib and erdafitinib in patients with ER+/HER2-/FGFR-amplified…
- Trial name
- NCT03238196
- Testing
- Erdafitinib, Palbociclib, Fulvestrant
- Where
- 6 sites in United States
- Volunteers
- 35 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
Metastatic Breast Cancer
4EVER - Efficacy, Safety, Health Economics, Translational Research of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer
The present multi-center, open-label, single-arm study aims to evaluate the efficacy and safety, quality of life and health resources utilization in postmenopausal women with hormone receptor positive breast cancer progressing…
- Trial name
- MACS2096 (NCT01626222)
- Testing
- Exemestane, Everolimus (RAD001)
- Where
- 84 sites in Germany
- Volunteers
- 301 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Trastuzumab Rezetecan vs Trastuzumab Deruxtecan in the Neoadjuvant Treatment of HER2 Positive Breast Cancer
This is a single-center, randomized, open-label, phase II interventional study. Eligible patients will be randomized 1:1 to receive either Trastuzumab-rezetecan (4.8 mg/kg Q3W) or T-DXd (5.4 mg/kg Q3W) for 8 neoadjuvant cycles.
- Trial name
- NCT07416253
- Testing
- Trastuzumab rezetecan, Trastuzumab deruxtecan
- Volunteers
- 68 people
- Sponsor
- Henan Cancer Hospital
Breast Cancer
XEBRA Study: An Observational Study of Xeloda (Capecitabine) in Combination With Docetaxel in First Line in Participants With HER2-Negative Metastatic Breast Cancer
This multicenter observational study will evaluate the efficacy and safety of Xeloda (capecitabine) in combination with docetaxel in first-line therapy in participants with HER2-negative metastatic breast cancer.
- Trial name
- NCT01777945
- Testing
- capecitabine, docetaxel
- Where
- 14 sites in Hungary
- Volunteers
- 46 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Neoadjuvant Chemotherapy With Myocet/Taxotere/Herceptin for HER2 Positive Breast Cancer Patients
This is an open-label study to assess the efficacy and tolerability of the combination Myocet®/Taxotere®/Herceptin® as primary treatment for HER2 positive breast cancer patients.
- Trial name
- NCT00129896
- Testing
- Myocet, Taxotere, Herceptin
- Where
- 16 sites in Spain
- Volunteers
- 73 people
- Sponsor
- Spanish Breast Cancer Research Group
HER2 Positive Breast Cancer, Left Ventricular Function Systolic Dysfunction
Cardiac Safety Study in Patients With HER2 + Breast Cancer
HER2 positive breast cancer cells have more HER2 receptor (a protein on the surface of cells) than normal breast cells. Approximately 30% of patients with breast cancer have HER2 positive breast cancer.
- Trial name
- SAFE-HEaRt (NCT01904903)
- Testing
- Trastuzumab, Pertuzumab, Ado Trastuzumab Emtansine
- Where
- 2 sites in United States
- Volunteers
- 31 people
- Sponsor
- Medstar Health Research Institute
Breast Cancer, Gastric Cancer
Biological Therapy in Treating Patients With Advanced Cancer
RATIONALE: A person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells.
- Conditions
- Breast Cancer, Gastric Cancer, Ovarian Cancer
- Trial name
- NCT00005956
- Testing
- HER-2/neu intracellular domain protein, therapeutic autologous dendritic cells
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Duke University
HER2-positive Breast Cancer
Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy
This is a single institution, observational research study in which patients are observed using DWI/DCE MRI imaging before and after receiving neoadjuvant anti-HER2 therapy.
- Trial name
- NCT03738553
- Testing
- MRI, Trastuzumab
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- University of Washington
Breast Cancer
S1222 Trial (Everolimus, Anastrozole and Fulvestrant) in Post-Menopausal Stage IV Breast Cancer
This randomized Phase III trial studies how well the combination of fulvestrant and everolimus together or the combination of anastrozole, fulvestrant and everolimus together, improve progression-free survival (PFS) versus…
- Trial name
- NCT02137837
- Testing
- Fulvestrant, Anastrozole, Everolimus
- Where
- 223 sites in United States
- Volunteers
- 37 people
- Sponsor
- SWOG Cancer Research Network
Breast Cancer, Radiotoxicity
HER2 Expression Detection and Radionuclide Therapy in Breast Cancer Using 99mTc/188Re Labeled Single Domain Antibody
To evaluate the safety, dosimetry and efficacy of 99mTc/188Re labeled anti-HER2-single domain antibody (Product Code Name: 99mTc-NM-02 and 188Re-NM-02) SPECT/CT imaging of HER2 expression and radionuclide therapy in Breast…
- Trial name
- NCT04674722
- Testing
- Injection of 99mTc-NM-02, Injection of 188Re-NM-02
- Where
- China
- Volunteers
- 43 people
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
HER2 Positive Metastatic Breast Cancer
A Study of Pyrotinib Plus Capecitabine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.This study is a single-arm, prospective, open label clinical study of pyrotinib plus capecitabine as the Therapy of brain metastases from…
- Trial name
- NCT03691051
- Testing
- Pyrotinib plus Capecitabine
- Where
- China
- Volunteers
- 78 people
- Sponsor
- Henan Cancer Hospital
Breast Neoplasms
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC
A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC
- Trial name
- NCT02771795
- Testing
- Herceptin (trastuzumab), SB3 (proposed trastuzumab biosimilar)
- Where
- 40 sites in Bulgaria, Czechia and 5 more
- Volunteers
- 538 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
De-escalation Therapy in Stage I ER-Positive Breast Cancer: A Non-Inferiority Trial
This study is a prospective, randomized, open-label, non-inferiority Phase III clinical trial, planning to enroll 2,934 patients, with a 1:1 allocation to either the conventional endocrine therapy group or the de-escalation…
- Trial name
- DESCENT (NCT07153757)
- Testing
- Endocrine Therapy of Physician's Choice
- Where
- China
- Volunteers
- 2,934 people
- Sponsor
- Fudan University
Breast Cancer
"Observational, Retrospective and Prospective, Non-interventional, Multicentre on the Use of Genomic Testing in the Management of Early Stage HR+/HER2- Breast Cancer"
The study aims to establish an Italian registry for the implementation of the use of genomic tests in patients with HR +/HER2- breast cancer at intermediate risk of recurrence after the entry into force of the Ministerial Decree…
- Trial name
- GIM29-GIMOMIC (NCT06871501)
- Where
- 25 sites in Italy
- Volunteers
- 1,000 people
- Sponsor
- Consorzio Oncotech
Breast Cancer
CNF2024 (BIIB021) HER2- (QD) HER2+ (BIW w/Herceptin) PK/PD Study
The goal of this clinical research study is to study the drug CNF2024 as a single agent or in combination with trastuzumab in patients with advanced breast cancer and to: find the highest dose of the drug CNF2024 as a single…
- Trial name
- NCT00412412
- Testing
- CNF2024, CNF2024 + trastuzumab
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Biogen
Breast Cancer, ER-positive Breast Cancer
Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer
The majority of patients (pts) with breast cancer have hormone receptor positive (HR+) disease, and this holds true for pts with advanced breast cancer (ABC).
- Conditions
- Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT05826964
- Testing
- AI+CDK4/6i, SERD+CDK4/6i, mTOR inhibitor + AI
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Miami
Breast Cancer, Cancer of the Breast
Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing
Historically, serial testing of patients with metastatic breast cancer has included a combination of physical exam, symptom evaluation, laboratory testing, and imaging.
- Trial name
- NCT04968964
- Testing
- DiviTum® TKa assay, Study Care Plans
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Washington University School of Medicine
Cancer
Role of Early Versus Late Switch to Lapatinib-Capecitabine
The study will be conducted as a multicenter prospective observational cohort study, trying to cover almost all Brazilian States, in a population of ErbB2 positive metastatic breast cancer patients, whose disease has progressed…
- Trial name
- (TYCO1) (NCT01357863)
- Testing
- Treatment
- Where
- 13 sites in Brazil
- Volunteers
- 3 people
- Sponsor
- GlaxoSmithKline
Breast Cancer
Miti-gene Recurrence Score in HR+/HER2- Chinese Breast Cancer Patients
Update and validate the performance of the 21-gene score in prognostic stratification for early-stage HR-positive, HER2-negative breast cancer in China.
- Trial name
- BC-MRS-01 (NCT07052734)
- Where
- China
- Volunteers
- 2,843 people
- Sponsor
- Sun Yat-sen University
HER2-positive Breast Cancer and Gastric Cancer
Clinical Study of 68Ga Labeled HER2 Affibody Analogues
The purpose of this study is to assess the dosimetric properties of the positron emission tomography (PET) imaging probe 68Ga labeled HER2 Affibody analogues and preliminarily evaluate its diagnosis value in patients with breast…
- Trial name
- NCT05411432
- Testing
- 68Ga labeled HER2 Affibody
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Xijing Hospital
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