Clinical trials: HER2 Low Breast Cancer
Hormone Receptor Positive, HER2-low or HER2-ultralow
A Study of Patritumab Deruxtecan (HER3-DXd) in Combination With Trastuzumab Deruxtecan (T-DXd) in Participants With HR-Positive, HER2-Low or HER2-Ultralow Unresectable or Metastatic Breast Cancer
The primary purpose of the study is to assess the safety, tolerability, and anti-tumor activity of HER3-DXd and T-DXd in the combination dosing regimens in participants with hormone receptor positive, HER2-low or HER2-ultralow…
- Conditions
- Hormone Receptor Positive, HER2-low or HER2-ultralow, Unresectable or Metastatic Breast Cancer
- Trial name
- NCT07701941
- Testing
- Patritumab deruxtecan, Trastuzumab deruxtecan
- Where
- 72 sites in United States, Belgium and 6 more
- Volunteers
- 220 people
- Sponsor
- Daiichi Sankyo
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation for Improved Breast Appearance in Pts w/Low Risk, Hormone Responsive Brst Ca
This phase II trial tests how well accelerated partial breast irradiation (APBI) delivered once per day works in ensuring an acceptable breast appearance in patients with low risk, hormone responsive breast cancer.
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma, HER2-Negative Breast Carcinoma
- Trial name
- NCT06008158
- Testing
- Accelerated Partial Breast Irradiation
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- City of Hope Medical Center
Breast Cancer
Discontinuation of CDK4/6 Inhibitors in Patients With Metastatic HR Positive, HER2 Negative Breast Cancer
This is a low-intervention, randomized, non-comparative, open-label, multicenter, prospective, phase II trial investigating discontinuation of CDK4/6 inhibitors in patients with metastatic HR positive, HER2 negative breast cancer…
- Trial name
- NCT06207734
- Testing
- Continuation of CDK4/6 inhibitor Palbociclib, Discontinuation of CDK4/6 inhibitor Palbociclib, Continuation of CDK4/6 inhibitor -Palbociclib
- Where
- 13 sites in Germany
- Volunteers
- 120 people
- Sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
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
Breast Cancer
Genomic and Transcriptomic Predictors of Sequential SG Sensitivity After T-DXd in ER+/HER2-Low Metastatic Breast Cancer
Advanced hormone positive (HR+), HER2 negative breast cancer continues to pose a challenge when patients have progressed on CDK4/6 inhibitor and endocrine therapy leaving limited treatment options.
- Trial name
- NCT06665178
- Testing
- Sacituzumab Govitecan
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- British Columbia Cancer Agency
HER2 Low Breast Carcinoma, Triple Negative Breast Cancer
ARX788 for Treating Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer
This phase II trial tests how well ARX788 works in treating patients diagnosed with HER2-low, locally advanced unresectable or metastatic breast cancer.
- Conditions
- HER2 Low Breast Carcinoma, Triple Negative Breast Cancer, Hormone-receptor-positive Breast Cancer, Hormone Receptor Positive Breast Carcinoma
- Trial name
- NCT06224673
- Testing
- ARX788, Computed Tomography (CT), Biospecimen Collection
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Laura Huppert, MD, BA
Breast Cancer
Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer
Evaluating the Efficacy of Disitamab Vedotin in Combination with RC148 Compared to Albumin-bound Paclitaxone Monotherapy or in Combination with Toripalimab for Subjects with HR-negative, HER2-low Expressing Unresectable Locally…
- Trial name
- NCT06642545
- Testing
- Disitamab Vedotin, RC148, Albumin-bound Paclitaxone
- Where
- China
- Volunteers
- 40 people
- Sponsor
- RemeGen Co., Ltd.
HER2-low Breast Cancer
A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer
This trial is a registered, phase III, randomized, open-label and multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable, locally recurrent or metastatic HER2-low breast cancer.
- Trial name
- NCT06957886
- Testing
- BL-M07D1, Capecitabine, Eribulin, Gemcitabine, Paclitaxel, or Albumin paclitaxel
- Where
- 2 sites in China
- Volunteers
- 566 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Breast Cancer
Implementation of Solid Digital PCR to Support Gold-standard Methods for Evaluation of HER2 Amplification Status: Focus on HER2-low Subtype
The goal of the retrospective phase of this study is to validate the specificity and the sensitivity of two Real-Time quantitative PCR based techniques in order to support the gold-standard approaches used to evaluate the HER2…
- Trial name
- CRANBERRY (NCT06813456)
- Where
- Italy
- Volunteers
- 234 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Invasive Breast Cancer, Inflammatory Breast Cancer Stage III
TRUDI: TDXD+Durva in HER2+/Low IBC
The purpose of this study is to test the safety and effectiveness of an investigational drug combination (trastuzumab deruxtecan and durvalumab) to learn whether the intervention works in treating Human Epidermal growth factor…
- Conditions
- Invasive Breast Cancer, Inflammatory Breast Cancer Stage III, HER2-positive Breast Cancer, HER2 Low Breast Adenocarcinoma
- Trial name
- TRUDI (NCT05795101)
- Testing
- Trastuzumab deruxtecan, Durvalumab
- Where
- 3 sites in United States
- Volunteers
- 63 people
- Sponsor
- Filipa Lynce, MD
Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma
A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood.
- Conditions
- Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma, HER2 Low Breast Neoplasms, HER2 Positive Breast Neoplasms
- Trial name
- NCT06157892
- Testing
- disitamab vedotin, tucatinib
- Where
- 135 sites in United States, Australia and 8 more
- Volunteers
- 54 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Breast Cancer
The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer: a Phase II Clinical Study
Evaluate the safety and efficacy of Pyrotinib in the transition from low-dose to normal-dose regimen for HER2-positive advanced first-line breast cancer
- Trial name
- NCT06254690
- Testing
- Pyrotinib dose escalation, Pyrotinib dose normal
- Where
- China
- Volunteers
- 102 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Breast Cancer, Neoadjuvant Therapy
The Study of Vidicizumab Combined With Tirelizumab in the Treatment of Breast Cancer With Low HER2 Expression
To evaluate the efficacy and safety of vidicizumab combined with tirelizumab in the treatment of early high-risk or locally advanced breast cancer with low HER2 expression
- Trial name
- NCT05861635
- Testing
- Disitamab Vedotin combined with Tislelizumab
- Where
- China
- Volunteers
- 42 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Breast Cancer, Serplulimab Combined With SHR-A1811 as Neoadjuvant Therapy for Triple-Negative Breast Cancer
Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer
To evaluate the efficacy and safety of Serplulimab in combination with Trastuzumab Restuzumab for the neoadjuvant treatment of triple-negative breast cancer, aiming to provide evidence for optimizing the strategy of combining…
- Trial name
- NCT07466303
- Testing
- Serplulimab, SHR-A1811
- Where
- China
- Volunteers
- 84 people
- Sponsor
- Xijing Hospital
Breast Cancer
Real-World Treatment of ADC-Resistant HER2-Low Advanced Breast Cancer
This is a multicenter, retrospective real-world study aiming to evaluate the efficacy and safety of post-antibody-drug conjugate (post-ADC) treatment strategies in patients with HER2-low advanced breast cancer who have developed…
- Trial name
- NCT07587983
- Where
- China
- Volunteers
- 220 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Breast Cancer
Dalpiciclib Plus Fulvestrant With Pyrotinib in Hormone Receptor-positive, HER2-low Advanced Breast Cancer That Progressed on Previous CDK4/6i Plus AI Therapy
The purpose of this study is to determine if the triplet combination of dalpiciclib, fulvestrant, and pyrotinib is safe and effective in the treatment of hormone receptor-positive, HER2-low locally advanced/metastatic breast…
- Trial name
- NCT05806671
- Testing
- Dalpiciclib, Pyrotinib, Fulvestrant
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Breast Cancer
Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer
This study will evaluate the safety, tolerability and efficacy of anlotinib and trastuzumab deruxtecan in human epidermal growth factor receptor 2 (HER2)-low unresectable and/or metastatic breast cancer who had received ≤1 line…
- Trial name
- NCT06331169
- Testing
- Anlotinib, Trastuzumab deruxtecan
- Where
- China
- Volunteers
- 42 people
- Sponsor
- Fudan University
Metastatic Breast Cancer, HER2 Low Breast Carcinoma
ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer
The goal of this study is to evaluate the safety and efficacy of elacestrant in combination with trastuzumab deruxtecan (T-DXd) in participants with hormone receptor-positive (HR+), HER2-low or HER2-ultralow, metastatic breast…
- Conditions
- Metastatic Breast Cancer, HER2 Low Breast Carcinoma, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- ERADICATE (NCT07198724)
- Testing
- Elacestrant, Trastuzumab Deruxtecan
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Kristina A. Fanucci
Breast Cancer, HER2-low-expressing Breast Cancer
Phase II Neoadjuvant Pyrotinib Combined With Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial
This is a single-arm, prospective, non-randomized, single-center, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib combined with epirubicin and cyclophosphamide followed by docetaxel in HR…
- Conditions
- Breast Cancer, HER2-low-expressing Breast Cancer, Hormone Receptor-positive Breast Cancer, Neoadjuvant Therapy
- Trial name
- NCT05165225
- Testing
- Pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Metastatic Breast Cancer, Triple Negative Breast Cancer
Toci +/- SOC Chemo for Metastatic Triple Negative and ER-positive, HER2-negative Breast Cancers
This is a randomized Phase II study of standard of care (SOC) chemotherapy monotherapy vs. SOC chemotherapy combined with tocilizumab biosimilar in Black and non-Black patients with metastatic triple negative and ER-positive…
- Conditions
- Metastatic Breast Cancer, Triple Negative Breast Cancer, Estrogen-receptor-low Breast Cancer, ER Positive, HER2 Negative Breast Cancer
- Trial name
- NCT05846789
- Testing
- SOC Chemotherapy, Tocilizumab/Tocilizumab Biosimilar
- Where
- 7 sites in United States
- Volunteers
- 168 people
- Sponsor
- Kathy Miller