Clinical trials: HER2 Low Breast Cancer
HER2-positive Metastatic Breast Cancer
QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
This study will assess whether a quantitative, HER2 assay can accurately and reliably discriminate between responders and non-responders among patients with HER2 IHCI+ metastatic breast cancer who are receiving T-Dxd.
- Trial name
- NCT06551116
- Testing
- CE-10-IVD
- Where
- 37 sites in United States
- Volunteers
- 200 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Breast Cancer
JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
This study is a randomized controlled, open-label, multicenter phase III clinical study evaluating the efficacy and safety of chemotherapy selected by investigator JSKN003 s in subjects with recurrent or metastatic breast cancer…
- Trial name
- NCT06079983
- Testing
- JSKN003, Capecitabine tablets, Gemcitabine hydrochloride for injection
- Where
- 87 sites in China
- Volunteers
- 400 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
T-dxd Resistant HER2-Positive, HER2 Low Metastatic Breast Cancer
Study of Trastuzumab Deruxtecan (T-DXd) in Combination With a RAGE Inhibitor in Patients With T-DXd-Resistant HER2-Positive or HER2-Low Metastatic Breast Cancer
This phase Ib/II trial aims to evaluate the safety and preliminary efficacy of combining Trastuzumab Deruxtecan (T-DXd) with Azeliragon, a receptor for advanced glycation end products (RAGE) inhibitor in patients with…
- Trial name
- RAGE (NCT07785856)
- Testing
- Azeliragon, T-DXd
- Volunteers
- 27 people
- Sponsor
- The Methodist Hospital Research Institute
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage 1 Breast Cancer AJCC v8
Testing Low Dose Tamoxifen for Invasive Breast Cancer, LoTam Trial
This phase III trial compares the effect of low dose tamoxifen to usual hormonal therapy, including aromatase inhibitors, in treating post-menopausal women with hormone positive, HER2 negative early stage breast cancer.
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage 1 Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma
- Trial name
- LoTam (NCT06671912)
- Testing
- Anastrozole, Letrozole, Exemestane
- Where
- 732 sites in United States, Puerto Rico
- Volunteers
- 1,556 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Breast Neoplasms, Triple Negative Breast Neoplasms
A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
Researchers are looking for new ways to treat types of breast cancer that are both: High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment Early-stage, which means the cancer is…
- Conditions
- Breast Neoplasms, Triple Negative Breast Neoplasms, HR Low-Positive/HER2-Negative Breast Neoplasms
- Trial name
- NCT06966700
- Testing
- Sacituzumab tirumotecan, Pembrolizumab, Rescue Medication
- Where
- 331 sites in United States, Argentina and 39 more
- Volunteers
- 2,400 people
- Sponsor
- Merck Sharp & Dohme LLC
HER2/Neu Negative, Invasive Breast Carcinoma
Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer
This pilot clinical trial studies how well endocrine therapy works in treating patients with HER2 negative, low risk breast cancer. Estrogen can cause the growth of breast cancer cells.
- Conditions
- HER2/Neu Negative, Invasive Breast Carcinoma, Postmenopausal, Stage 0 Breast Cancer
- Trial name
- NCT03238703
- Testing
- Anastrozole, Exemestane, Laboratory Biomarker Analysis
- Where
- United States
- Sponsor
- Fred Hutchinson Cancer Center
Breast Cancer Metastatic
MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer.
A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2.
- Trial name
- NCT03321981
- Testing
- Zenocutuzumab, Trastuzumab, Vinorelbine
- Where
- 25 sites in United States, Belgium and 5 more
- Volunteers
- 105 people
- Sponsor
- Merus B.V.
Cancer
QUILT-3.013: Study of Ad5 [E1-, E2b-]-HER2/Neu Vaccine (ETBX-021) in Subjects With Unresectable Locally Advanced or Metastatic HER2-Expressing Breast Cancer
The purpose of this study is to determine whether ETBX-021 is safe and effective in the treatment of unresectable locally advanced or metastatic HER2-low-expressing breast cancer.
- Trial name
- NCT02751528
- Testing
- ETBX-021
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- NantBioScience, Inc.
Breast Cancer
A Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.
The study is being conducted to evaluate the safety, tolerability， preliminary efficacy, pharmacokinetics, and immunogenicity of SHR-A1811 combined with capecitabine in treatment of unresectable or metastatic breast cancer with…
- Trial name
- NCT05845138
- Testing
- SHR-A1811 for injection ; capecitabine
- Where
- 9 sites in China
- Volunteers
- 116 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Breast Cancer
Evaluate Trastuzumab Plus Standard Chemotherapy Given Before Surgery in Breast Cancer Patients With Low HER 2 Expression
The purpose of this study is to find out if there is a benefit of adding Herceptin (trastuzumab) to standard chemotherapy in this type of breast cancer.
- Trial name
- NCT00944047
- Testing
- nab-paclitaxel, trastuzumab, Doxorubicin
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- University of Kansas Medical Center
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 Cancer
A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer
This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with…
- Trial name
- NCT06112379
- Testing
- Dato-DXd, Durvalumab, Pembrolizumab
- Where
- 283 sites in United States, Australia and 24 more
- Volunteers
- 1,902 people
- Sponsor
- AstraZeneca
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
Breast Cancer
Disitamab Vedotin(RC48) Combined With Penpulimab(AK105) for Neoadjuvant Treatment of HER2-low Breast Cancer
To evaluate the efficacy and safety of Disitamab Vedotin combined with Penpulimab as neoadjuvant therapy in patients with HER2-low early or locally advanced breast cancer
- Trial name
- NCT05726175
- Testing
- Disitamab Vedotin, Penpulimab
- Where
- China
- Volunteers
- 20 people
- Sponsor
- West China Hospital
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
HER2-positive Early Breast Cancer
NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer
ADAPT-HER2-IV will address question of optimal neoadjuvant therapy in patients with less advanced -HER2+ EBC. ADAPT-HER2-IV is planned as a superiority trial to demonstrate higher pCR rates in both clinically relevant subgroups…
- Trial name
- ADAPTHER2-IV (NCT05704829)
- Testing
- Trastuzumab deruxtecan, Standard-of-Care
- Where
- 44 sites in Germany
- Volunteers
- 702 people
- Sponsor
- Women's Cancer Study Group GmbH
Breast Cancer (Early Breast Cancer)
Skipping Hormone Therapy in Low-Risk Early Breast Cancer
The goal of this clinical trial is to determine whether a selected population of women with early-stage, low-risk breast cancer can avoid hormone therapy without increasing their risk of relapse.
- Trial name
- NoELA (NCT07661927)
- Testing
- Removing Endocrine Therapy
- Where
- 41 sites in France
- Volunteers
- 700 people
- Sponsor
- UNICANCER
HER2-positive Breast Cancer
Testing Radiation and HER2-targeted Therapy Versus HER2-targeted Therapy Alone for Low-risk HER2-positive Breast Cancer
This Phase III trial compares the recurrence-free interval (RFI) among patients with early-stage, low risk HER2+ breast cancer who undergo breast conserving surgery and receive HER2-directed therapy, and are randomized to not…
- Trial name
- HERO (NCT05705401)
- Testing
- Standard of Care Adjuvant Breast Radiation, Standard of Care HER2-targeted Therapy Without Adjuvant Breast Radiation
- Where
- 418 sites in United States, Puerto Rico
- Volunteers
- 1,300 people
- Sponsor
- NRG Oncology
Recurrent or Metastatic Solid Tumors
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXD) in the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma…
- Trial name
- NCT06330064
- Testing
- Ifinatamab deruxtecan
- Where
- 120 sites in United States, Argentina and 16 more
- Volunteers
- 680 people
- Sponsor
- Daiichi Sankyo
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.