Clinical trials: HER2 Low Breast Cancer
Untreated Early-stage or Locally Advanced Breast Cancer
Neoadjuvant SHR-A1811 Plus Adebrelimab in HR Negative/Low & HER2 Low Breast Cancer Patients
The study is being conducted to evaluate the preliminary efficacy, safety, and pharmacokinetic characteristics of the combination of SHR-A1811 with Adebrelimab Injection in treatment-naive patients with early-stage or locally…
- Trial name
- NCT06592625
- Testing
- SHR-A1811, Adebrelimab
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Breast Cancer
BEYOND Study: A Multicentre, Prospective, Observational Study of Real-world Treatment Patterns and Outcomes of Trastuzumab Deruxtecan in Patients With HR Positive, HER2-low or Ultra-low Metastatic Breast Cancer Previously Treated With Endocrine Therapy
BEYOND study is designed to generate the first real-world data from GCC countries on the patient characteristics, treatment patterns, survival outcomes, and safety of T-DXd in patients with HRpositive,HER2-low or HER2-ultralow…
- Trial name
- BEYOND (NCT07597993)
- Testing
- TDxd
- Where
- 9 sites in Oman, Qatar and 2 more
- Volunteers
- 109 people
- Sponsor
- AstraZeneca
Female Breast Cancer
PROOFS-Registry - Premenopausal Women With Breast Cancer Optimally Treated With OFS
There is only limited data for premenopausal patients in general, as well as for differences in the use of OFS in the subgroups of pre- and perimenopausal patients, respectively.
- Trial name
- PROOFS (NCT05792150)
- Where
- 71 sites in Germany
- Volunteers
- 1,470 people
- Sponsor
- Women's Cancer Study Group GmbH
Breast Neoplasms
Clinical Study for the Treatment of Breast Cancer: the Patient Will Receive Afatinib Plus Letrozole or Letrozole Alone
The purpose of the study is to compare the efficacy of treatment with afatinib plus letrozole to treatment with letrozole alone in women diagnosed with a specific type of breast cancer.
- Trial name
- NCT02115048
- Testing
- Letrozole, Afatinib
- Where
- 26 sites in United States, Bosnia and Herzegovina and 2 more
- Volunteers
- 44 people
- Sponsor
- Translational Research in Oncology
Breast Cancer Metastatic, Breast Cancer Stage IV
Detecting Tumor DNA in the Blood of HR+/HER2-low Metastatic Breast Cancer Patients to Find Candidates for T-DXd Therapy
After an initial screening phase to identify patients with persistent blood circulating DNA tumors, patients will be enrolled in the treatment phase that was designed as an open-label, multicentre, phase II study, to test the…
- Trial name
- SAFIR3LibHERty (NCT06680596)
- Testing
- trastuzumab derxutecan
- Where
- 40 sites in France
- Volunteers
- 80 people
- Sponsor
- UNICANCER
Metastatic Breast Cancer, HER 2 Low-expressing Breast Cancer
PERCIST Evaluation of Trastuzumab Deruxtecan in the Treatment of HER2 Low Breast Cancer
The development of trastuzumab deruxtecan (T-DXd), an anti-HER2 conjugated antibody, has changed the therapeutic landscape of breast cancer.
- Trial name
- PERPETUAL (NCT07130344)
- Testing
- TAP CT-scan, Bone scintigraphy, 18F-FDG PET-CT
- Where
- France
- Volunteers
- 262 people
- Sponsor
- Centre Paul Strauss
Leucogen, Ribociclib
the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Breast Cancer
This study is a multicenter, single-arm, open-label Phase II exploratory clinical trial designed to evaluate whether prophylactic use of leucogen can reduce the incidence of Grade 3 or higher neutropenia in early-stage HR+/HER2…
- Conditions
- Leucogen, Ribociclib, Neutropenia (Low White Blood Cell Count), Breast Cancer
- Trial name
- NCT07380646
- Testing
- Treat Regimen
- Where
- China
- Volunteers
- 97 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Hormone-receptor-positive Breast Cancer, HER2-low Breast Cancer
Study of Predictors of Clinical Outcomes in Patients With HR+ and HER2-low/Negative Breast Cancer
There is a lack of data on clinical and patient factors that are associated with poor survival in patients with HR+ and HER2-low/negative breast cancer treated with neoadjuvant chemotherapy or endocrine therapy.
- Conditions
- Hormone-receptor-positive Breast Cancer, HER2-low Breast Cancer, HER2-negative Breast Cancer
- Trial name
- NCT06040593
- Testing
- No drug
- Where
- United States
- Volunteers
- 927 people
- Sponsor
- Daiichi Sankyo
HER2 Positive Untreated Metastatic Breast Cancer, Asymptomatic or Low Symptomatic Brain Metastasis in Breast Cancer
Intrathecal Pertuzumab and Trastuzumab in Patients With New Untreated Asymptomatic or Low Symptomatic Brain Metastasis in HER2 Positive Breast Cancer
The purpose of this research study is to determine how well pertuzumab and trastuzumab works in treating breast cancer that has spread to the brain.
- Trial name
- NCT02598427
- Testing
- Pertuzumab, Trastuzumab
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Kimberly Blackwell
Breast Cancer
Estimation of the Prevalence of HER2 Low and Describe the SoC, Treatment Patterns, and Outcome in Real-world Practice Among Unresectable and/or Metastatic Breast Cancer Patients With HER2 Low Status
This is a worldwide, multicenter, non-interventional, retrospective study of patient medical records from metastatic breast cancer (mBC) patients previously identified as human epidermal growth factor receptor 2 negative…
- Trial name
- NCT04807595
- Testing
- None (Observational study)
- Where
- 13 sites in United States, Australia and 8 more
- Volunteers
- 798 people
- Sponsor
- AstraZeneca
Metastatic Breast Cancer
A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer
DESTINY-Breast 08 will investigate the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies in patients with Metastatic HER2-low Advanced or Metastatic Breast Cancer
- Trial name
- DB-08 (NCT04556773)
- Testing
- Trastuzumab deruxtecan, Durvalumab, Paclitaxel
- Where
- 37 sites in United States, Australia and 8 more
- Volunteers
- 138 people
- Sponsor
- AstraZeneca
Mammary Cancer
Omission of Surgery and Sentinel Lymph Node Dissection in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti- HER2-based Neoadjuvant Therapy (ELPIS Trial)
This is a prospective, single arm, open-label, exploratory study in women with primary operable HER2-positive, HER2-enriched(HER2-E)/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff…
- Trial name
- ELPIS (NCT04301375)
- Testing
- Pertuzumab and trastuzumab FDC subcutaneous, Paclitaxel, TDM1
- Where
- Spain
- Volunteers
- 27 people
- Sponsor
- David Garcia Cinca
Patients With Low HER2 Expression (IHC 1+ or IHC 2+/ISH-) and HER2 IHC 0 Advanced Breast Cancer
The Efficacy of Combined Peripheral Blood CTCs and Serum HER2 Detection in Docetaxel-based Treatment for HER2 Low-expression Breast Cancer
This study is a multicenter, double-cohort clinical research aimed at systematically evaluating the value of jointly detecting the HER2 expression of CTCs/CTECs and the serum HER2 ECD level in predicting the efficacy of T-DXd…
- Trial name
- NCT07670182
- Testing
- Anti-HER2-ADC drug Deruxtepracabine
- Volunteers
- 100 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Triple Negative Breast Cancer, HER2-negative Breast Cancer
DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer
The purpose of the study is to find out if an investigational vaccine called Dendritic Cell (DC) vaccine given together with standard of care chemotherapy drugs can help people with Triple Negative and HR low positive breast…
- Trial name
- DecipHER (NCT05504707)
- Testing
- HER2 - primed Dendritic cells, HER3 - primed Dendritic cells
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Cancers With HER2 Expression
A First in Human Study of BAY2701439 to Look at Safety, How the Body Absorbs, Distributes and Excretes the Drug, and How Well the Drug Works in Participants With Advanced Cancer Expressing the HER2 Protein
In this study, researchers want to learn about the safety of drug BAY2701439 and how well the drug works in patients with advanced cancer that has the protein HER2 (Human Epidermal growth factor Receptor 2) and cannot be cured by…
- Trial name
- NCT04147819
- Testing
- BAY2701439
- Where
- 6 sites in United States, United Kingdom
- Volunteers
- 14 people
- Sponsor
- Bayer
Breast Cancer
A Clinical Trial of TQB2102 for Injection in the Treatment of HER2 Low-Expressing Recurrent/Metastatic Breast Cancer
The study is a Phase III, randomized, multicenter, open-label study in HER2-low, HR+ metastatic breast cancer subjects who are patients with locally advanced or metastatic breast cancer with low HER2 expression in the recurrent…
- Trial name
- NCT06561607
- Testing
- TQB2102 for Injection, Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel)
- Where
- 34 sites in China
- Volunteers
- 542 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Breast Cancer
Axillary Nodal Burden in HER2+ and TNBC
This study aimed to evaluated rates of pathologic axillary nodal metastasis in patients with with early-stage HER2-positive BC or TNBC who had clinically node-negative status on preoperative ultrasonography and underwent upfront…
- Trial name
- NCT07211451
- Testing
- Breast conserving surgery with axillary surgery
- Where
- South Korea
- Volunteers
- 1,571 people
- Sponsor
- Gangnam Severance Hospital
Locally Advanced or Metastatic Breast Cancer
A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC
This study is a multicenter, open-label, phase 2 clinical study to evaluate the efficacy, safety and pharmacokinetics of YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive…
- Trial name
- NCT06439771
- Testing
- YL202 should be intravenously infused
- Where
- China
- Volunteers
- 180 people
- Sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
Breast Cancer, HR Positive/HER2 Low Breast Cancer
Neoadjuvant Dalpiciclib + AI → SHR-A1811 for HR+/HER2-Low Breast Cancer
This is a phase II, single-arm, prospective exploratory study to evaluate the efficacy and safety of neoadjuvant dalpiciclib (a CDK4/6 inhibitor) plus an aromatase inhibitor (AI) followed by SHR-A1811 (an anti-HER2 antibody-drug…
- Trial name
- TD-DASHER-01 (NCT07618923)
- Testing
- Dalpiciclib 125mg, Aromatase Inhibitor, SHR-A1811
- Volunteers
- 20 people
- Sponsor
- Tang-Du Hospital
Breast Cancer
Low Dose of Metronomic Cyclophosphamide and Capecitabine in Pretreated HER2-negative Metastatic Breast Cancer
The purpose of this study is to evaluate the role of low dose metronomic cyclophosphamide and capecitabine in pretreated metastatic breast cancer.
- Trial name
- NCT01526512
- Testing
- metroCX
- Where
- 2 sites in China
- Volunteers
- 72 people
- Sponsor
- Fudan University