Clinical trials: Her2 Positive Metastatic Breast Cancer, open to volunteers
Breast Cancer
Fulvestrant or Capecitabine Combined With Pyrotinib in HR+/HER2+ Metastatic Breast Cancer
Capecitabine combined with pyrotinib is the standard protocol for HR+/HER2+ advanced breast cancer after trastuzumab failure, but the incidence of grade 3 hand-foot-syndrome was 16.4%.
- Trial name
- NCT04646759
- Testing
- Fulvestrant combined with Pyrotinib, Capecitabine combined with Pyrotinib
- Where
- China
- Volunteers
- 516 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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
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
Metastatic Urothelial Carcinoma, Breast Cancer
Imaging Study in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLC
This imaging study aims to assess the feasibility, biodistribution, and dosimetry of the imaging agent in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC.
- Conditions
- Metastatic Urothelial Carcinoma, Breast Cancer, TNBC - Triple-Negative Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
- Trial name
- NCT07671092
- Testing
- RYZ211/212
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 40 people
- Sponsor
- RayzeBio, Inc.
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
Breast Cancer
A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer
A study to assess the efficacy and safety of Dato-DXd in the pre-chemotherapy setting for patients with metastatic HR-positive, HER2 IHC 0 breast cancer.
- Trial name
- TB06 (NCT07205822)
- Testing
- Dato-DXd
- Where
- 40 sites in United States, China and 4 more
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
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
Advanced Breast Cancer
A Phase Ib/II Study of QLC1401 Combined With CDK4/6 or mTOR Inhibitors in ER+/HER2- Advanced Breast Cancer
This study is an open-label, multicenter, Phase Ib/II clinical trial designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic characteristics of QLC1401 tablets in combination with CDK4/6 inhibitors or mTOR…
- Trial name
- NCT07173556
- Testing
- QLC1401
- Volunteers
- 96 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
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
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
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
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 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.
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, 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
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.
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
Advanced Solid Tumors
A Study to Evaluate ATX-898 in Participants With Advanced Solid Tumors
Study ATX-898-101 is a phase 1/2 open-label study evaluating the safety, tolerability, pharmacokinetic, and preliminary efficacy of ATX-898 as monotherapy and in combination with anti-neoplastic agents in selected solid tumors.
- Trial name
- NCT07767474
- Testing
- ATX-898, ATX-898, fulvestrant, ribociclib
- Where
- 6 sites in United States, Australia
- Volunteers
- 343 people
- Sponsor
- Antares Therapeutics, Inc