Clinical trials: HER2/Neu Positive, active
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
Malignant Neoplasm of Stomach, Unspecified
Clinical Study to Evaluate the Safety and Anti-Tumor Activity of AB-201
HER2 is highly expressed on the surface of several cancer types, including breast and gastric/gastroesophageal junction (GEJ) cancers.
- Trial name
- NCT07333820
- Testing
- AB-201 Dose escalation
- Where
- South Korea
- Volunteers
- 18 people
- Sponsor
- Yonsei University
Metastatic Breast Cancer, HRD-Positive/HER2-Negative Advanced Breast Cancer
Fluorizoparib Plus Apatinib Versus Chemotherapy in HRD-positive, HER2-negative Advanced Breast Cancer
This is a Phase III clinical trial for patients with a specific type of advanced breast cancer that is HER2-negative and has a biomarker called "Homologous Recombination Deficiency (HRD)-positive." The study aims to compare the…
- Trial name
- NCT07371910
- Testing
- Chemotherapy/ADC Regimen, Fluorizoparib, Apatinib
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing Olaparib Either Alone or in Combination With Atezolizumab in BRCA Mutant Non-HER2-positive Breast Cancer
This randomized phase II trial studies how well olaparib with or without atezolizumab work in treating patients with non-HER2-positive breast cancer that has spread to nearby tissue or lymph nodes (locally advanced), that cannot…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Unresectable Breast Carcinoma, Metastatic Breast Carcinoma
- Trial name
- NCT02849496
- Testing
- Atezolizumab, Biopsy Procedure, Biospecimen Collection
- Where
- 58 sites in United States
- Volunteers
- 89 people
- Sponsor
- National Cancer Institute (NCI)
HER2-positive Breast Cancer, Leptomeningeal Metastasis
Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease
The purpose of this study is to find out if radiation therapy followed by intrathecal trastuzumab and pertuzumab is safe and will result in improved survival in HER2 positive breast cancer which has metastasized to the…
- Conditions
- HER2-positive Breast Cancer, Leptomeningeal Metastasis, Leptomeningeal Disease
- Trial name
- NCT04588545
- Testing
- Radiation Therapy, Pertuzumab, Trastuzumab
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
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 Breast Cancer
Roll-over Study to Allow Continued Access to Ribociclib
The purpose of this study is to assess the long-term safety of ribociclib (LEE011) in combination with other drugs and provide post-trial access (PTA) to participants who are currently receiving treatment with ribociclib in…
- Trial name
- NCT05161195
- Testing
- Ribociclib, Letrozole, Anastrozole
- Where
- 73 sites in United States, Argentina and 20 more
- Volunteers
- 134 people
- Sponsor
- Novartis Pharmaceuticals
HR+/HER2+ Early Breast Cancer
Fovinaciclib Plus Aromatase Inhibitors and Dual HER2 Blockade in a Response-Adapted Neoadjuvant Strategy for HR-Positive/HER2-Positive Early Breast Cancer
This prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant fovinaciclib in combination with aromatase inhibitors and dual HER2 blockade in patients with HR-positive/HER2-positive early…
- Trial name
- TAYLOR-003 (NCT07616427)
- Testing
- Fovinaciclib, Aromatase Inhibitors, Trastuzumab + Pertuzumab
- Where
- 3 sites in China
- Volunteers
- 100 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Breast Cancer
Stage I HER2 Positive Invasive Breast Cancer De-escalation Study(IRIS)
This is an open label, phase II study evaluating the efficacy and safety of trastuzumab combined with oral chemotherapy or endocrine therapy in patients with HER-2 positive stage I breast cancer.
- Trial name
- IRIS (NCT04383275)
- Testing
- capecitabine and trastuzumab, endocrine therapy and trastuzumab
- Where
- China
- Volunteers
- 367 people
- Sponsor
- Fudan University
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
HER2-positive Early-stage Breast Cancer
Optimize Neoadjuvant Therapy in HER2-Positive Early-Stage Breast Cancer
This is an open-label phase 2 study to evaluate the pCR rate in patients diagnosed with HER2 positive breast cancer treated on an adaptive clinical trial design.
- Trial name
- EUREKA (NCT07402473)
- Testing
- Trastuzumab, Pertuzumab, Docetaxel
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- Rutgers, The State University of New Jersey
Advanced Solid Tumors
Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors
This study is the first-in-human (Phase I/II) trial of SYS6045, a multicenter, open-label, dose-escalation and dose-expansion clinical study.
- Trial name
- NCT07122063
- Testing
- SYS6045
- Where
- China
- Volunteers
- 266 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen
This study will assess the efficacy and safety of SHR-A1811 compared with treatment chosen by the investigator in participants with HER2-positive (defined as immunohistochemistry [IHC] 3+ or IHC 2+/in situ hybridization [ISH]+)…
- Trial name
- NCT06123494
- Testing
- SHR-A1811, Ramucirumab / Paclitaxel/ Docetaxel/ Irinotecan
- Where
- China
- Volunteers
- 360 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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.
HER2-positive Breast Cancer, Breast Cancer
Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]
A phase 2 open-label, randomized, multi-center trial to evaluate the efficacy and safety of neoadjuvant trastuzumab, pertuzumab and weekly paclitaxel (THP) as compared to neoadjuvant trastuzumab, pertuzumab, pembrolizumab and…
- Trial name
- NCT03747120
- Testing
- Paclitaxel, Trastuzumab, Pertuzumab
- Where
- 5 sites in United States
- Volunteers
- 138 people
- Sponsor
- University of Texas Southwestern Medical Center
Urology
Efficacy and Safety of Two Bladder-preserving Treatment Durations With Disitamab Vedotin Plus Toripalimab Combination in Her2-expressing Muscle-invasive Bladder Cancer: A Phase II, Open-Label, Randomized Clinical Trial
This study aims to evaluate the efficacy of disitamab vedotin combined with toripalimab as a bladder-preserving treatment combination in patients with HER2 positive locally advanced MIBC, including one year bladder-intact DFS…
- Trial name
- NCT07151560
- Testing
- 6 cycle RC48 and JS001, 12 cycle RC48 and JS001
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Renmin Hospital of Wuhan University
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