Clinical trials: HER2 Positive Metastatic Breast Cancer
Carcinoma, Ductal, Breast, Breast Cancer
G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
This is a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with fulvestrant in patients with hormone receptor-positive, HER2-negative metastatic breast cancer.
- Conditions
- Carcinoma, Ductal, Breast, Breast Cancer, Breast Neoplasm
- Trial name
- NCT02983071
- Testing
- G1T38, Fulvestrant
- Where
- 8 sites in Bulgaria, Georgia and 2 more
- Volunteers
- 102 people
- Sponsor
- G1 Therapeutics, Inc.
Breast Cancer Stage IV
Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management
This is an open-label, single arm, non-randomized, multicenter, phase 2 study assessing the efficacy and safety of T-DXd as first-line treatment in HER2-positive advanced/metastatic BC patients (N=300).
- Trial name
- TOP-REAL (NCT07371585)
- Testing
- Digital Health Tools, T-DXd, Pertuzumab
- Where
- 27 sites in France, Germany and 1 more
- Volunteers
- 300 people
- Sponsor
- SOLTI Breast Cancer Research Group
HER2/Neu Positive, HLA-A2 Positive Cells Present
Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab
This phase I/II trial studies the side effects of vaccine therapy and to see how well it works in treating patients with stage IV major histocompatibility complex, class I, A2 antigen (HLA-A2) and human epidermal growth factor…
- Conditions
- HER2/Neu Positive, HLA-A2 Positive Cells Present, Stage IV Breast Cancer, Stage IV Ovarian Cancer
- Trial name
- NCT00194714
- Testing
- HER-2/neu Peptide Vaccine, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- University of Washington
Breast Cancer
Artificial Intelligence and Machine Learning to Guide CDK4/6 Inhibitor Rechallenge in Breast Cancer.
The goal of this clinical trial is to learn if an artificial intelligence model will be able to select patients with advanced breast cancer who may respond to a second cyclin-dependent kinase 4/6 (CDK4/6) inhibitor after they…
- Trial name
- AIM-BRIGHT (NCT07227233)
- Testing
- A CDK4/6 inhibitor different from the first that the participant had received, plus fulvestrant., Treatment of physician's choice
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- University of California, San Diego
HER2-positive Breast Cancer
IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer
This is a randomized, multicenter, open-label, phase 3 study evaluating the efficacy, safety, and tolerability of IBI354 combined with or without pertuzumab vs.
- Trial name
- NCT07377643
- Testing
- Trastuzumab, IBI354, Docetaxel
- Where
- China
- Volunteers
- 540 people
- Sponsor
- Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Metastatic Breast Cancer
ErbB2 Positive Metastatic Breast Cancer
Objectives: Phase I part Primary Objective: To determine the recommended dose of the combination of lapatinib with Lipo-Dox as first line chemotherapy in patients with ErbB2 positive metastatic breast cancer.
- Trial name
- NCT01658358
- Testing
- Lapatinib, Lipo-Dox
- Where
- Taiwan
- Volunteers
- 15 people
- Sponsor
- China Medical University Hospital
HER2-positive Locally Advanced or Metastatic Breast Cancer
A Phase III Trial of Pertuzumab Retreatment in Previously Pertuzumab Treated Her2-Positive Advanced Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of pertuzumab, trastuzumab and chemotherapy as a pertuzumab retreatment compared to trastuzumab and chemotherapy in locally advanced or metastatic breast cancer…
- Trial name
- PRECIOUS (NCT02514681)
- Testing
- Trastuzumab, Pertuzumab, Docetaxel
- Where
- 3 sites in Japan
- Volunteers
- 226 people
- Sponsor
- Japan Breast Cancer Research Group
Locally Advanced Breast Cancer, Metastatic Breast Cancer
A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Breast Cancer
The main purpose of this study is to prove non-inferiority, as well as to demonstrate the comparability of safety and immunogenicity of RPH-051 and Perjeta® in combination with trastuzumab and docetaxel as the 1st line therapy…
- Trial name
- NCT07386938
- Testing
- RPH-051, Docetaxel, Perjeta®
- Where
- 45 sites in Russia
- Volunteers
- 246 people
- Sponsor
- R-Pharm
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
Metastatic HER2-positive Breast Cancer With Brain Metastasis
Kadcyla In pAtients With bRAin Metastasis
Women with breast cancer often develop metastases in the brain. Currently, treatment of these metastases is difficult and relies on radiotherapy or surgery which often fail.
- Trial name
- KIARA (NCT03203616)
- Testing
- KADCYLA 160 MG Injection
- Sponsor
- Jules Bordet Institute
HER2-positive Breast Cancer
Safety, Effectiveness and Quality of Life of Trastuzumab Deruxtecan in Patients with HER2+ Breast Cancer
Collection of data in real life conditions on satefy, effectiveness and quality of life of trastuzumab deruxtecan in patients with metastatic or unresectable HER2-positive breast cancer.
- Trial name
- NCT05149014
- Where
- France
- Volunteers
- 306 people
- Sponsor
- Daiichi Sankyo France
Breast Cancer
Tucatinib, Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer
This is a multicenter run-in phase Ib / roll-over phase II study of triple targeted drug combination (HER2-targeted small molecule inhibitor tucatinib, CDK4/6 inhibitor palbociclib and aromatase inhibitor letrozole) as a first or…
- Trial name
- NCT03054363
- Testing
- Tucatinib in Combination with Palbociclib and Letrozole
- Where
- 6 sites in United States
- Volunteers
- 42 people
- Sponsor
- University of Colorado, Denver
Metastatic Breast Cancer, HER2-positive Breast Cancer
Trial of BDC-1001 +/- Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer
This is an open-label, Phase 2 study to evaluate preliminary anti-tumor activity, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of BDC-1001 administered as a single agent and in…
- Trial name
- NCT05954143
- Testing
- BDC-1001, Pertuzumab
- Where
- 4 sites in United States, Spain
- Volunteers
- 11 people
- Sponsor
- Bolt Biotherapeutics, Inc.
HER2 Amplified, Advanced Breast Cancer
A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer
The purpose of this study was to evaluate the efficacy of enzalutamide with trastuzumab in patients with HER2+ AR+ metastatic or locally advanced breast cancer.
- Conditions
- HER2 Amplified, Advanced Breast Cancer, Human Epidermal Growth Factor Receptor 2 (HER2)
- Trial name
- NCT02091960
- Testing
- Enzalutamide, Trastuzumab
- Where
- 39 sites in United States, Belgium and 4 more
- Volunteers
- 103 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Breast Cancer, HER2-positive Breast Cancer
A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer
The study is being conducted to evaluate the efficacy, safety and tolerability of pyrotinib combination with CDK4/6 Inhibitor SHR6390 in advanced HER2-Positive breast cancer patients who prior trastuzumab-treated.
- Trial name
- INPHASE (NCT04095390)
- Testing
- Pyrotinib, SHR6390, Letrozole
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Jinming Yu
Breast Cancer
An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.
Participants that have breast cancer that has spread to other parts of the body, is positive for a protein called HER2, and has not responded to standard treatment.
- Trial name
- NCT02657343
- Testing
- Ribociclib, T-DM1, Trastuzumab
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer
Paclitaxel Plus Pembrolizumab vs. Paclitaxel Weekly in ER+ Luminal B Metastatic Breast Cancer
PELICAN is a randomised phase II trial that aims to evaluate the efficacy and safety of paclitaxel plus pembrolizumab relative to paclitaxel alone, in patients with locally advanced or metastatic ER-positive, HER2-negative…
- Trial name
- PELICAN (NCT03841747)
- Testing
- Pembrolizumab, Paclitaxel
- Sponsor
- Queen Mary University of London
Metastatic Breast Cancer
A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)
This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or…
- Trial name
- KATE3 (NCT04740918)
- Testing
- Trastuzumab Emtansine, Atezolizumab
- Where
- 51 sites in United States, Australia and 17 more
- Volunteers
- 96 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study of Herceptin (Trastuzumab) in Combination With Avastin (Bevacizumab) and Sequential Xeloda (Capecitabine) or Docetaxel in Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer
This single arm, open-label study will evaluate the safety and efficacy of Herceptin in combination with Avastin and sequential Xeloda in patients with locally recurrent or metastatic HER2-positive breast cancer after early…
- Trial name
- NCT00964704
- Testing
- bevacizumab [Avastin], capecitabine [Xeloda], docetaxel
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Inetetamab Plus Rapamycin and Chemotherapy for HER2+ Metastatic Breast Cancer With Abnormal Activation of PAM Pathway
This is a multi-center,randomized,phase 3 clinical trial. In the study, HER2-positive metastatic breast cancer patients with abnormal activation of PI3K/Akt/mTOR pathway after progression on trastuzumab are enrolled and…
- Trial name
- NCT04736589
- Testing
- Inetetamab, Rapamycin, Pyrotinib
- Where
- China
- Volunteers
- 270 people
- Sponsor
- Peking Union Medical College