Clinical trials: HER-2 Positive Malignant Carcinoma of Breast
Breast Cancer, HER2-positive Breast Cancer
HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission
Thie purpose of this study is to find out whether a personalized treatment approach-using a series of ctDNA tests along with standard imaging scans to help decide when to step up (escalate) or decrease (de-escalate) sequential…
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Breast Cancer Stage IV
- Trial name
- NCT07459673
- Testing
- Personalis NeXT Personal, Natera Signatera, fam-trastuzumab deruxtecan-nxki (T-DXd)
- Where
- 7 sites in United States
- Volunteers
- 60 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
HER2-positive Breast Cancer, Breast Cancer
T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer
This is a single arm, phase II study to evaluate if the combination of T-DM1 with palbociclib improves progression-free survival in patients with metastatic HER2 positive breast cancer.
- Conditions
- HER2-positive Breast Cancer, Breast Cancer, Breast Cancer Stage, Recurrent Breast Cancer
- Trial name
- T-DM1 (NCT03530696)
- Testing
- Palbociclib, T-DM1
- Where
- 16 sites in United States
- Volunteers
- 55 people
- Sponsor
- University of Arizona
Metastatic Breast Cancer
A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus the Combination of Trastuzumab Plus Docetaxel in Patients With HER2-positive Breast Cancer
This is a Phase III, randomized, multicenter, multinational, two-arm, open-label clinical trial to investigate a first-line treatment of participants with human epidermal growth factor receptor-2 (HER2)-positive metastatic breast…
- Trial name
- NCT02144012
- Testing
- Trastuzumab, Trastuzumab Emtansine, Docetaxel
- Where
- 8 sites in Malaysia, South Korea and 2 more
- Volunteers
- 49 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
HER2-positive Breast Cancer Project Initiated by Investigators
This study will assess the objective response rate (ORR), safety, progression-free survival (PFS) , overall survival (OS), 6-month survival rate, 12-month survival rate, 18-month survival rate, 24-month survival rate, disease…
- Trial name
- NCT05346328
- Testing
- Injection of A166
- Volunteers
- 48 people
- Sponsor
- Fudan University
HER2-positive Breast Cancer
Tucatinib in Combination With Oral Etoposide andTrastuzumab in Patients With Metastatic HER2+ Breast Cancer
This is an open-label, multicenter, phase II study to evaluate the efficacy, safety, tolerability, pharmacokinetics of the combination of tucatinib-Oral VP16-trastuzumab in patients with HER2-positive metastatic breast cancer…
- Trial name
- TUC-TOC (NCT05955170)
- Testing
- Tucatinib in Combination of Oral VP16 and trastuzumab
- Where
- 13 sites in France
- Volunteers
- 66 people
- Sponsor
- Institut Curie
HER2-positive Breast Cancer
Phase Ⅱ Study of Pegylated Liposomal Doxorubicin（PLD）Plus Trastuzumab in HER-2 Positive Metastatic Breast Cancer
This is a single-center phase Ⅱ study designed to evaluated the efficacy and safety of pegylated liposomal doxorubicin（PLD）in combination with trastuzumab in HER-2 positive metastatic breast cancer .
- Trial name
- NCT03933319
- Testing
- pegylated liposomal doxorubicin
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Chinese Academy of Medical Sciences
HER2-positive Breast Cancer
Tumor Markers for Efficacy of Dual-Target Therapy in HER2+ Breast Cancer
This is a prospective, randomized study to compare the efficacy of TP (Taxane plus Carboplatin) chemotherapy combined with dual-HER2 blockade (trastuzumab and pertuzumab) versus TP chemotherapy plus single-HER2 blockade…
- Trial name
- NCT07115095
- Testing
- TP Chemotherapy + Trastuzumab + Pertuzumab, TP Chemotherapy + Trastuzumab
- Where
- China
- Volunteers
- 98 people
- Sponsor
- Nanlin Li
Breast Cancer
Studying Blood and DNA Samples From Patients With Breast Cancer Treated With Chemotherapy With or Without Trastuzumab
RATIONALE: Studying samples of blood and DNA in the laboratory from patients who received chemotherapy with or without trastuzumab may help doctors learn more about the effects of trastuzumab on cells.
- Trial name
- NCT01562288
- Testing
- DNA analysis, gene expression analysis, polymerase chain reaction
- Volunteers
- 1,576 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Breast Cancer
A Study to Look at the Combination of Chemotherapy, Trastuzumab and RAD001 in HER2 Positive Breast Cancer
The primary objective of this study is to assess whether a combination of chemotherapy, Trastuzumab and RAD001 will result in no evidence of microscopic disease at the time of surgery in 50% of enrolled patients.
- Trial name
- NCT01163929
- Testing
- paclitaxel
- Sponsor
- University of Kansas
HER2-positive, Metastatic Breast Cancer
ARX788 in HER2-positive Breast Cancer Patients With Brain Metastases
A Phase 2 Study of ARX788 in HER2-positive, Metastatic Breast Cancer Patients whose Disease is resistant or refractory to Tyrosine kinase inhibitors (TKI).
- Trial name
- NCT05018702
- Testing
- ARX788
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Fudan University
HER2 Positive Breast Carcinoma, Stage IIIA Breast Cancer
Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer
This phase II trial studies how well copper Cu64-DOTA-trastuzumab positron emission tomography (PET) works in predicting response to treatment with trastuzumab and pertuzumab before surgery in patients with human epidermal growth…
- Conditions
- HER2 Positive Breast Carcinoma, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Trial name
- NCT02827877
- Testing
- Copper Cu 64-DOTA-Trastuzumab, Laboratory Biomarker Analysis, Pertuzumab
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- City of Hope Medical Center
Breast Neoplasms, Cancer of the Breast
A Trial for HER2 Positive Breast Cancer Patients With Metastatic Disease
This phase II trial that includes Gemcitabine 1,250mg/m2 to be administered over approximately 30 minutes on days 1 and 8, every 21 days and Trastuzumab 8 mg/kg IV to be administered over 90 minutes on day 1 of the first cycle…
- Conditions
- Breast Neoplasms, Cancer of the Breast, Breast Cancer
- Trial name
- NCT00191373
- Testing
- Gemcitabine, Trastuzumab
- Where
- 13 sites in United States
- Volunteers
- 66 people
- Sponsor
- Eli Lilly and Company
HER2-positive Breast Cancer
The Resistance Mechanism of Trastuzumab Deruxtexan in HER2 Positive Breast Cancer Patients.
This study is the spatial transcriptomic approach for revealing the resistance mechanism of trastuzumab deruxtexan in HER2 positive breast cancer patients.
- Trial name
- NCT06330012
- Testing
- GeoMx data analysis with clinical outcome
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Samsung Medical Center
HER2 Positive Breast Cancer
Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Docetaxel and Carboplatin in HER2 Positive Breast Cancer Patients.
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 for evaluating the efficacy and safety of neoadjuvant pyrotinib and…
- Trial name
- NCT03735966
- Testing
- Pyrotinib plus trastuzumab and docetaxel and carboplatin
- Where
- China
- Volunteers
- 75 people
- Sponsor
- Henan Cancer Hospital
HER2-positive Breast Cancer
Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody for Injection
A randomized, multicenter, Phase I/IIa clinical study to evaluate the tolerability, safety, efficacy, pharmacokinetics and immunogenicity after single/multiple administration of recombinant anti-HER2 humanized monoclonal antibody…
- Trial name
- NCT04170595
- Testing
- GB221,2 mg/kg, GB221,6 mg/kg, Herceptin,6 mg/kg
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Genor Biopharma Co., Ltd.
Breast Cancer
Cancer Stem Cell Biomarkers as a Predictor of Response to Trastuzumab in Samples From Patients With Breast Cancer Previously Treated in the NSABP-B-31 Trial
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
- Trial name
- NCT01424865
- Testing
- fluorescence in situ hybridization, immunohistochemistry staining method, immunologic technique
- Volunteers
- 1,874 people
- Sponsor
- NSABP Foundation Inc
Breast Cancer, Brain Metastasis
T-DM1 Alone Versus T-DM1 and Metronomic Temozolomide in Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases Following Stereotactic Radiosurgery
Background: Sometimes breast cancer spreads (metastasizes) to the brain. Researchers want to study new treatments for brain metastases. The drug Temozolomide is approved to treat brain tumors.
- Conditions
- Breast Cancer, Brain Metastasis, Brain Cancer
- Trial name
- NCT03190967
- Testing
- T-DM1, TMZ
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer
This non-interventional prospective study will assess the safety of Herceptin SC (subcutaneous administration) as used in routine clinical practice.
- Trial name
- NCT02286362
- Where
- 97 sites in France
- Volunteers
- 510 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Breast Cancer, Metastatic Breast Cancer
Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, open-label, multi-center, parallel design study of the combination of pyrotinib, trastuzumab and chemotherapy…
- Trial name
- NCT05346861
- Testing
- Trastuzumab plus chemotherapy, Trastuzumab in combination with pyrotinib plus chemotherapy
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Fudan University
HER2-positive Metastatic Breast Cancer
Study of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Advanced Breast Cancer
This is an open-label, multicenter, dose-escalation and parallel-group expansion Phase II clinical trial to evaluate the efficacy, safety and tolerability of KN026 in combination with palbociclib and fulvestrant in women or male…
- Trial name
- NCT04778982
- Testing
- KN026 combined with Palbociclib and Fulvestrant
- Where
- China
- Volunteers
- 4 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd