Clinical trials: HER-2 Positive Malignant Carcinoma of Breast, open to volunteers
Leptomeningeal Metastasis of HER2-positive Breast Cancer
Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Trastuzumab in Breast Cancer With Leptomeningeal Metastasis
Evaluate the efficacy and safety of Intrathecal Administration of Thiotepa in Combination with Trastuzumab via the Ommaya Reservoir in Breast Cancer with Leptomeningeal Metastasis
- Trial name
- NCT07263425
- Testing
- Intrathecal Administration of Thiotepa in Combination with Trastuzumab via the Ommaya Reservoir
- Where
- China
- Volunteers
- 26 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Breast Cancer, Triple Negative Breast Cancer
Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery
This single arm study aims to evaluate the efficacy and safety of a non-surgical approach, consisting of radiotherapy (RT) alone, for patients who have achieved a complete pathological response (pCR) following neoadjuvant…
- Conditions
- Breast Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer, Neoadjuvant Chemotherapy
- Trial name
- BETTY-CRASY (NCT06281210)
- Testing
- Omission of surgical treatment
- Where
- 2 sites in Italy
- Volunteers
- 77 people
- Sponsor
- European Institute of Oncology
Metastatic Breast Cancer With HER2 Positive
SHR-A1811 Combine With Pyrotinib for Locally Advanced/Metastatic HER2 Positive Breast Cancer
The goal of this clinical trial is to learn if SHR-A1811 combine with Pyrotinib is safe and tolerable for patients with HER2 positive breast cancer. It will also learn about the anti-tumor efficacy of this combination therapy.
- Trial name
- NCT07132242
- Testing
- SHR-A1811 4.0mg/kg, Pyrotinib 240mg, SHR-A1811 4.8mg/kg
- Volunteers
- 84 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Breast Neoplasm Female
A Prospective, Open, Multicenter Single-arm Clinical Studie of Docetaxel, Carboplatin Combined With Inetetamab and Pyrotinib in the Treatment of Local-advanced HER2-positive Breast Cancer
This study is a prospective, open, multi-center, single arm trial. The treatment group will receive six cycles of docetaxel, carboplatin combined with Inetetamab and Pyrotinib before surgery.
- Trial name
- neoPICD (NCT06234137)
- Testing
- Docetaxel, Carboplatin, Inetetamab
- Where
- China
- Volunteers
- 154 people
- Sponsor
- Wang Ouchen
Breast Cancer, Brain Metastases
A Two-cohort Study of SHR-A1811 in the Treatment of HER2-positive Breast Cancer With Brain Metastases
This is a multi-center, open-label, two-cohort study. The purpose of this study is to evaluate the safety, tolerability and efficacy of SHR-A1811 in the treatment of HER2-positive breast cancer with brain and leptomeningeal…
- Conditions
- Breast Cancer, Brain Metastases, Leptomeningeal Metastasis
- Trial name
- NCT07177950
- Testing
- SHR-A1811, radiotherapy
- Volunteers
- 51 people
- Sponsor
- Peking University Cancer Hospital & Institute
HER2-positive Breast Cancer
Adjuvant Dual Anti-HER2 Therapy in Patients With Small, Node-negative, HER2-positive Breast Cancer
This phase II trial aims to study the efficacy and safety of adjuvant Pyrotinib plus trastuzumab in patients with tumors <8mm, node-negative, HER2-positive breast cancer.
- Trial name
- SHERO (NCT04158856)
- Testing
- Pyrotinib, Trastuzumab
- Volunteers
- 60 people
- Sponsor
- xuexin he
HER2-positive Breast Cancer, Metastatic Breast Cancer
SMP-656 for HER2-Positive Advanced Breast Cancer
The goal of this clinical trial is to learn if single-agent SMP-656 works to treat patients with HER2-positive locally advanced or metastatic breast cancer who have progressed after prior HER2-targeted topoisomerase inhibitor…
- Conditions
- HER2-positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC)
- Trial name
- NCT07726342
- Testing
- SMP-656 Injection
- Where
- 15 sites in China
- Volunteers
- 60 people
- Sponsor
- Chengdu SciMount Pharmatech Co., Ltd.
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
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
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
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
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
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
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 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
HER2 Positive Breast Cancer
Randomized Controlled Clinical Study of Efficacy and Safety of Initumab Combined with Pyrrotinib and Chemotherapeutic Agents in Neoadjuvant Therapy for HER2-positive Breast Cancer with Different Treatment Cycles
The purpose of this study was to explore the efficacy and safety of initumab combined with pyrrotinib and chemotherapy for 4 cycles and 6 cycles of neoadjuvant therapy for HER2-positive breast cancer, and to explore the efficacy…
- Trial name
- NCT06868017
- Testing
- Cohort A will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 4 doses, Cohort B will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 6 doses
- Volunteers
- 208 people
- Sponsor
- The First Hospital of Jilin University
Breast Carcinoma Metastatic in Lymph Node, HER2 Positive Breast Carcinoma
Validation of TAD in HER-2 with More Than 2 Lymph Nodes
The main objective of the study is to validate the DAT technique in patients with Her2-positive breast cancer who have more than two positive axillary lymph nodes at diagnosis.
- Trial name
- DAD-HER2 (NCT06821490)
- Testing
- Targeted axillary dissection and subsequently a lymphadenectomy
- Where
- Spain
- Volunteers
- 21 people
- Sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
ER Positive, HER2 Positive Breast Cancer
Elacestrant in Advanced Triple Positive Breast Cancer
The purpose of this study to assess the safety and efficacy of elacestrant, a selective estrogen receptor degrader (SERD) and dual biologic therapy, trastuzumab and pertuzumab, in patients with triple-positive breast cancer with…
- Trial name
- NCT07612215
- Testing
- Elacestrant, Trastuzumab, Pertuzumab
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- NYU Langone Health