Clinical trials: HER2 Positive Breast Cancer, open to volunteers
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
HR+/HER2-negative Breast Cancer
A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer
The goal of this clinical trial is to evaluate the safety and efficacy of TOS-358 in women with HR+ HER2- metastatic breast cancer whose tumors have a mutation in PIK3CA and who meet all other study enrollment criteria.
- Trial name
- NCT05683418
- Testing
- TOS-358, Fulvestrant, Palbociclib
- Where
- 18 sites in United States, Spain
- Volunteers
- 241 people
- Sponsor
- Totus Medicines
HER2-positive Advanced Breast Cancer
Efficacy and Safety of Inetetamab Combined With Pyrotinib and Vinorelbine in ABC
This is a prospective, no interventional, single arm cohort study, which aims to study the efficacy and safety of inetetamab combined with pyrotinib and vinorelbine in the Treatment of HER2 positive advanced breast cancer in the…
- Trial name
- HER2-VIP (NCT05856383)
- Testing
- Inetetamab Combined With Pyrotinib and Vinorelbine
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Zhejiang Cancer Hospital
Breast Cancer, HER2-positive
A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC)
This is a Phase 2, single-site, single-arm open-label trial of zanidatamab in patients with early stage, low risk HER2+ BC. The primary objective is to determine the efficacy of zanidatamab for patients with early stage HER2/neu…
- Trial name
- NCT05035836
- Testing
- Zanidatamab, Letrozole, Tamoxifen
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- M.D. Anderson Cancer Center
HER 2 Positive Advanced Breast Cancer
HER2-positive Breast Cancer Without Intravenous Neoadjuvant Therapy
1. The primary goal of this clinical trial is to evaluate the pathological complete response (pCR) rate of oral paclitaxel solution combined with subcutaneous pertuzumab and trastuzumab in the neoadjuvant treatment of early or…
- Trial name
- NCT07848633
- Testing
- - Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, subcutaneous pertuzumab and trastuzumab fixed-dose combination for a total of 6 cycles
- Volunteers
- 65 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Breast Cancer
A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer
This Phase III trial adopts a randomized, open label, positive drug control, and multicenter trial design. Subjects who meet the criteria are randomly divided into 1:1 groups and receive treatment with TQB2102 injection or…
- Trial name
- NCT07003074
- Testing
- TQB2102 for Injection, Docetaxel combined + Trastuzumab +Pertuzumab
- Where
- 25 sites in China
- Volunteers
- 642 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
HER2-positive Breast Cancer
Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer
Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and high risk to recurrence and metastasis.
- Trial name
- NeraHER2 (NCT06693024)
- Testing
- neratinib
- Where
- China
- Volunteers
- 2,806 people
- Sponsor
- Shu Wang
Breast Cancer, HER 2 Negative Breast Cancer
Efti in Patients With Hormone Receptor Positive/HER2-neg Breast Cancer
The goal of this interventional study is to determine pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment.
- Conditions
- Breast Cancer, HER 2 Negative Breast Cancer, HR Positive/HER-2 Negative Breast Cancer, Stage 1-3
- Trial name
- NCT07102940
- Testing
- Eftilagimod Alfa (Efti), Docetaxel-cyclophosphamide (TC) intravenous (i.v), Dose dense Adriamycin-cyclophosphamide (AC) i.v
- Volunteers
- 50 people
- Sponsor
- George Washington University
HER2-positive Advanced Solid Tumor
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.
- Trial name
- NCT05150691
- Testing
- DB-1303/BNT323, Pertuzumab Injection, Ritonavir
- Where
- 102 sites in United States, Australia and 4 more
- Volunteers
- 796 people
- Sponsor
- DualityBio Inc.
Brain Cancer, Brain Metastases
Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases
The purpose of this study is to determine whether AGuIX (Activation and Guidance of Irradiation by X-ray) gadolinium-based nanoparticles make radiation work more effectively in the treatment of patients with brain metastases that…
- Conditions
- Brain Cancer, Brain Metastases, Melanoma, Lung Cancer
- Trial name
- NCT04899908
- Testing
- Stereotactic Radiation, AGuIX gadolinium-based nanoparticles
- Where
- 2 sites in United States
- Volunteers
- 134 people
- Sponsor
- Brigham and Women's Hospital
HER2-positive Breast Cancer
Basket Study for Oligo-metastatic Breast Cancer
The study will include patients with HER2-positive breast cancer and 1- 3 distant metastatic lesions, all amenable for curative intervention. Patients will be stratified by prior therapy and ER expression.
- Trial name
- ANISE (NCT05982678)
- Testing
- Trastuzumab deruxtecan
- Where
- Netherlands
- Volunteers
- 72 people
- Sponsor
- The Netherlands Cancer Institute
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the…
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma
- Trial name
- NCT07391774
- Testing
- Anastrozole, Biospecimen Collection, Bone Scan
- Where
- 258 sites in United States, Puerto Rico
- Volunteers
- 1,978 people
- Sponsor
- National Cancer Institute (NCI)
HER2-positive Breast Cancer
Asian Multicenter Prospective Study in HER2 Positive Early Breast Cancer for Detecting MRD by ctDNA;HARMONY Study
This study will assess minimal residual disease (MRD) in HER2-positive early breast cancer patients in Asian countries. The purpose is to evaluate the relation between the detection rate of MRD and recurrence.
- Trial name
- NCT05433753
- Where
- Japan
- Volunteers
- 60 people
- Sponsor
- National Cancer Center, Japan
HER2-positive, Unresectable, Locally Advanced or Metastatic Breast Cancer, SKB264
SKB264 Plus Inetetamab in HER2-Positive Metastatic Breast Cancer Patients Progressing After T-DXd Treatment
This is a prospective, single-arm, single-center, Phase II clinical study designed to assess the preliminary efficacy and safety of SKB264 Plus Inetetamab plus inetetamab for the treatment of HER2-positive, unresectable, locally…
- Conditions
- HER2-positive, Unresectable, Locally Advanced or Metastatic Breast Cancer, SKB264, Inetetamab
- Trial name
- SHINE-HER (NCT07182721)
- Testing
- SKB264 Plus Inetetamab
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Fudan University
HER2-positive Breast Cancer, Advanced Breast Cancer
The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).
This is a multi-center real-world study, in which patients who meet the inclusion criteria will receive treatment with Pyrotinib + Trastuzumab + Taxanes.
- Trial name
- NCT06217185
- Testing
- Pyrotinib, Trastuzumab, Taxanes
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Hebei Medical University Fourth Hospital
Breast Neoplasms
A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer
This study will include two groups of patients: Cohort 1 and Cohort 2. Cohort 1: will help researchers learn how a medicine called imlunestrant (LY3484356) affects a specific type of breast cancer.
- Trial name
- preEMBER (NCT07287098)
- Testing
- Imlunestrant, Goserelin, Tamoxifen 20 mg
- Where
- 90 sites in United States, Belgium and 5 more
- Volunteers
- 600 people
- Sponsor
- Eli Lilly and Company
HR-positive, HER2-negative Breast Cancer, TNBC - Triple-Negative Breast Cancer
Gene-edited T Regulatory Cells (CRG-150) for the Treatment of Relapsed/Refractory Malignancies
The goal of this Phase 1/2a interventional study is to evaluate the safety and tolerability of CRG-150 in relapsed/refractory HR+HER2- breast cancer, Triple Negative Breast Cancer (TNBC) and prostate cancer.
- Conditions
- HR-positive, HER2-negative Breast Cancer, TNBC - Triple-Negative Breast Cancer, Prostate Cancer
- Trial name
- NCT07730125
- Testing
- CRG-150
- Volunteers
- 67 people
- Sponsor
- CoRegen, Inc.
Breast Cancer, Advanced HR+/HER2- Breast Cancer
Study of Sacituzumab Govitecan With Atropine to Improve Tolerability in Advanced TNBC and HR+/HER2- Breast Cancer
The SATROPIN study is an international, multicenter, open-label, single-arm, phase II clinical trial to assess whether the use of prophylactic administration of atropine may prevent diarrhea in participants with unresectable…
- Conditions
- Breast Cancer, Advanced HR+/HER2- Breast Cancer, Advanced Triple-Negative Breast Cancer
- Trial name
- SATROPIN (NCT07367178)
- Testing
- Sacituzumab Govitecan (SG), Atropine, G-CSF (Granulocyte colony-stimulating factor)
- Volunteers
- 30 people
- Sponsor
- MedSIR
Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast…
- Conditions
- Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Trial name
- ALISCA-Breast1 (NCT06369285)
- Testing
- Alisertib, Endocrine therapy
- Where
- 53 sites in United States, Portugal and 1 more
- Volunteers
- 225 people
- Sponsor
- Puma Biotechnology, Inc.
Her 2 Positive Breast Cancer
A Study of A166 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer
Evaluation of the efficacy of A166 in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with TOP1 inhibitor Antibody-Drug Conjugates
- Trial name
- NCT07299825
- Testing
- A166
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.