Clinical trials: HER2-positive
Breast Neoplasms
Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
The purpose of study is to determine tolerability and safety profile of H3B-6545 in Japanese women with ER-positive, HER2-negative breast cancer, and also to confirm the dose applicability to Japanese.
- Trial name
- NCT04568902
- Testing
- H3B-6545, Antihistamine
- Where
- 2 sites in Japan
- Volunteers
- 33 people
- Sponsor
- Eisai Co., Ltd.
Breast Cancer
Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer
This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor…
- Trial name
- NCT05950945
- Testing
- Trastuzumab Deruxtecan
- Where
- 88 sites in United States, Australia and 8 more
- Volunteers
- 250 people
- Sponsor
- Daiichi Sankyo
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.
Advanced Solid Tumors, HER2-positive Breast Cancer
A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors
This will be a Phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination in participants with HER2-positive advanced solid tumors with or without…
- Trial name
- NCT05593094
- Testing
- ZN-A-1041, ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1b, ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1b
- Where
- 36 sites in United States, Australia and 5 more
- Volunteers
- 210 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study of Patients With HER2-Positive Metastatic Breast Cancer
This is a prospective observational cohort study designed to describe effectiveness and safety (treatment outcomes and clinically significant cardiac adverse events, respectively) in patients with HER2-positive metastatic breast…
- Trial name
- NCT00105456
- Volunteers
- 1,000 people
- Sponsor
- Genentech, Inc.
HER2-Positive Early Breast Cancer
A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer
This is a Phase II, randomized, multicentre, multinational, open-label, cross-over study in adult patients who have completed neoadjuvant chemotherapy with neoadjuvant pertuzumab and trastuzumab and have undergone surgical…
- Trial name
- PHranceSCa (NCT03674112)
- Testing
- Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC), Pertuzumab IV, Trastuzumab IV
- Where
- 40 sites in United States, Argentina and 15 more
- Volunteers
- 160 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Recurrent or Metastatic Breast Cancer
A Study of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line Treatment for HER2-Positive Recurrent or Metastatic Breast Cancer
This study is a randomized, controlled, open-label, multicenter, phase II superiority clinical trial. The planned study population consists of participants with HER2-positive recurrent or metastatic breast cancer who have not…
- Trial name
- NCT07545044
- Testing
- JSKN003, Trastuzumab, Pertuzumab
- Volunteers
- 60 people
- Sponsor
- Shanghai JMT-Bio Inc.
Colorectal Cancer Metastatic, Advanced Colorectal Cancer
TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer
This is a Phase II trial designed to determine the optimal dose and evaluate the effectiveness of TL938 and trastuzumab in treating patients with HER2+ colorectal cancer that has metastasized or recurred and is inoperable.
- Trial name
- NCT06589830
- Testing
- TL938 Capsules, Trastuzumab
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Suzhou Teligene Ltd.
Breast Neoplasms
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
Primary objective: Compare disease-free survival in women with human epidermal growth factor receptor 2 (HER2)-neu-expressing node-positive or high-risk node-negative operable breast cancer treated with adjuvant doxorubicin…
- Trial name
- NCT00021255
- Testing
- Doxorubicin, Cyclophosphamide, Docetaxel
- Where
- 42 sites in United States, Argentina and 40 more
- Volunteers
- 3,222 people
- Sponsor
- Sanofi
Breast Neoplasms
A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer
The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery.
- Trial name
- eMonarcHER (NCT04752332)
- Testing
- Abemaciclib, Standard Adjuvant ET
- Where
- 115 sites in United States, Argentina and 18 more
- Volunteers
- 111 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
The purpose of this study is to learn about the safety and effects of the study medicine PF-07248144 when given along with fulvestrant for the possible treatment of HR-positive, HER2-negative advanced or metastatic breast cancer.
- Trial name
- NCT07062965
- Testing
- PF-07248144, Fulvestrant, Everolimus
- Where
- 433 sites in United States, Argentina and 29 more
- Volunteers
- 400 people
- Sponsor
- Pfizer
HR+ HER2- Breast Cancer
Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants…
- Trial name
- NCT07558733
- Testing
- Serabelisib, Sapanisertib, Fulvestrant
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- Faeth Therapeutics
Breast Cancer
Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer
The purpose of this study is to determine if BMS-690514 + letrozole will be more effective than lapatinib + letrozole in patients who have metastatic hormone receptor positive breast cancer after developing progressive disease…
- Trial name
- NCT01068704
- Testing
- BMS-690514, Lapatinib, Letrozole
- Where
- 8 sites in United States, Argentina and 2 more
- Volunteers
- 4 people
- Sponsor
- Bristol-Myers Squibb
HER2 Amplified Breast Cancer
A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib
This study will investigate colon pathology in patients with HER2-positive breast cancer treated with neratinib. Colonoscopy will be performed after eligibility has been confirmed, prior to administration of the first dose of…
- Trial name
- NCT04366713
- Testing
- Neratinib, Capecitabine, Loperamide
- Where
- Portugal
- Volunteers
- 6 people
- Sponsor
- Puma Biotechnology, Inc.
Breast Cancer
DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy in patients with HER2-positive breast cancer.
- Trial name
- NCT06178159
- Testing
- Disitamab Vedotin Injection, Pertuzumab Injection, Toripalimab
- Where
- China
- Volunteers
- 40 people
- Sponsor
- RemeGen Co., Ltd.
HER2-positive Advanced Malignant Solid Tumors
Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors
This is a single-arm, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of Anti-HER2 CAR-T cell injection in patients with HER2-positive advanced malignant solid tumors.
- Trial name
- NCT06658951
- Testing
- Anti-HER2 CAR-T cells
- Where
- China
- Volunteers
- 30 people
- Sponsor
- UTC Therapeutics Inc.
Adenocarcinoma, Gastric, Neoplasm, Breast
DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein
HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells.
- Trial name
- NCT03368196
- Testing
- DS-8201a
- Where
- 2 sites in Taiwan
- Volunteers
- 12 people
- Sponsor
- Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company
HER2-positive Advanced Breast Cancer
The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer
To evaluate the safety and efficacy of BAT8001 for the treatment of HER2-positive advanced breast cancer, using lapatinib in combination with capecitabine as the positive control drug.
- Trial name
- NCT04185649
- Testing
- BAT8001 for injection, Lapatinib, Capecitabine
- Where
- 51 sites in China
- Volunteers
- 410 people
- Sponsor
- Bio-Thera Solutions
HER2-positive Breast Cancer
MagSense® Human Epidermal Growth Factor Receptor 2 (HER2) Imaging Agent (MSH2IA)
This Phase 1b/2 study is designed as an open-label, multicenter, 3 group, interventional study in which Phase 1b will evaluate the pharmacokinetics (PK) of MSH2IA and Phase 2 will confirm lowest effective dose as well as evaluate…
- Trial name
- NCT07885683
- Testing
- The MagSense® HER2 Imaging Agent (MSH2IA)
- Volunteers
- 70 people
- Sponsor
- Imagion Biosystems, Inc.
Advanced Solid Tumor, Metastatic Breast Cancer
A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer
This is a multicenter, open label, nonrandomized, sequential dose escalation/dose ranging, multiple dose study designed to evaluate the safety, toxicity, and PK as well as preliminary efficacy of BTX-A51 alone and in combination…
- Trial name
- NCT04872166
- Testing
- BTX-A51
- Where
- 6 sites in United States
- Volunteers
- 112 people
- Sponsor
- Edgewood Oncology Inc.