Clinical trials: HER2 Low Breast Cancer
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
HER2-positive Breast Cancer, Metastatic Cancer
PRE-ISPY Phase I/II Oncology Platform Program
PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced…
- Conditions
- HER2-positive Breast Cancer, Metastatic Cancer, Metastatic Breast Cancer, Metastatic
- Trial name
- PRE-ISPY (NCT05868226)
- Testing
- ALX148, Fam-Trastuzumab Deruxtecan-Nxki, Zanidatamab
- Where
- 10 sites in United States
- Volunteers
- 280 people
- Sponsor
- QuantumLeap Healthcare Collaborative
Breast Cancer, HER2-low Breast Cancer
TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd
The purpose of this study is to test the safety and effectiveness of the sequence of two investigational drugs (trastuzumab deruxtecan followed by datopotamab deruxtecan, or datopotamab deruxtecan followed by trastuzumab…
- Conditions
- Breast Cancer, HER2-low Breast Cancer, Metastatic Breast Cancer, HER2-negative Breast Cancer
- Trial name
- TRADE DXd (NCT06533826)
- Testing
- Trastuzumab Deruxtecan, Datopotamab Deruxtecan
- Where
- 11 sites in United States
- Volunteers
- 357 people
- Sponsor
- Ana C Garrido-Castro, MD
Hormone Receptor-Positive Breast Cancer, HER2 Low Breast Carcinoma
Neoadjuvant Culmerciclib Combined With Endocrine Therapy for Hormone Receptor-Positive， Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer
This is a single-center, open-label, randomized phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant Culmerciclib combined with aromatase inhibitor versus aromatase-inhibitor monotherapy in patients…
- Conditions
- Hormone Receptor-Positive Breast Cancer, HER2 Low Breast Carcinoma, Early-Stage Breast Cancer
- Trial name
- NCT07796880
- Testing
- Culmerciclib, Aromatase Inhibitor (AI)
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer
Use of Trastuzumab to Induce Increased ER Expression in ER-negative/Low, Her-2/Neu Positive Breast Cancer
The majority pf breast cancers present as ER-positive, many of which are able to be targeted with multiple hormonal therapies. Altering ER-negative tumors to increase ER expression has the potential to benefit patients by making…
- Trial name
- NCT00726180
- Testing
- trastuzumab (Herceptin®)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Michigan Rogel Cancer Center
Breast Cancer Stage IV, HER2-low Breast Cancer
HER2-PET as a Precision Imaging Tool for Treatment With HER2-ADC in HER2-expressing mBC
This is a prospective, multi-center, open-label, exploratory diagnostic phase II imaging trial for patients with metastatic breast cancer with at least one line of systemic therapy.
- Conditions
- Breast Cancer Stage IV, HER2-low Breast Cancer, Molecular Imaging
- Trial name
- NCT06830382
- Testing
- Positron emission tomografy with [68Ga]Ga-ABY-025
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Renske Altena
Breast Cancer
Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer
The purpose of this study is to evaluate the Safety and Efficacy of Neoadjuvant study of DV in combination Toripalimab i or sequence chemotherapy in HR-negative, HER2 low-expressing Breast Cancer
- Trial name
- NCT06227117
- Testing
- Disitamab Vedotin Injection （18 weeks）, Toripalimab （18weeks）, Carboplatin
- Where
- 5 sites in China
- Volunteers
- 120 people
- Sponsor
- RemeGen Co., Ltd.
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
Breast Cancer, HER2-low Breast Cancer
Distribution of the Homologous Recombination-related (HRR) Genesmutationsand HRD in Breast Cancer
This is a cross-sectional and an observational study, investigator-initiated study in HER2-low breast cancer patients. Approximately 255 subjects with HRD (homologous recombination deficiency) assessment will be enrolled in this…
- Trial name
- NCT05466786
- Testing
- Standard Management
- Where
- China
- Volunteers
- 255 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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
Breast Cancer
To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer
- Trial name
- NCT06389006
- Testing
- Disitamab Vedotin for Injection, Toripalimab, Epirubicin
- Where
- China
- Volunteers
- 79 people
- Sponsor
- RemeGen Co., Ltd.
Breast Cancer Metastatic
A Phase II Study of SHR-A1811 Combined With Radiotherapy in HER2-positive and HER2-low Breast Cancer Brain Metastases
A prospective, single-arm study to explore the efficacy and safety of SHR-A1811 combined with radiotherapy in patients with HER2-positive or HER2-low brain metastases
- Trial name
- NCT06975462
- Testing
- SHR-A1811 and radiotherapy
- Volunteers
- 30 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial
This phase II ComboMATCH treatment trial studies the effect of adding a drug called BYL719 (alpelisib) to the usual treatment of olaparib in patients with breast cancer that has spread from where it first started (breast) to…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma, Unresectable HER2-Negative Breast Carcinoma
- Trial name
- NCT05967286
- Testing
- Alpelisib, Biopsy, Biospecimen Collection
- Sponsor
- National Cancer Institute (NCI)
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
Trastuzumab-rezetecan, HER2-low Breast Cancer
Efficacy and Safety of Trastuzumab-rezetecan in HER2-Expressing Breast Cancer
This study is a multicenter, observational, real-world investigation. The research plans to enroll 300 HER2-positive and HER2-low breast cancer patients who meet the inclusion criteria.
- Conditions
- Trastuzumab-rezetecan, HER2-low Breast Cancer, HER2-positive Breast Cancer
- Trial name
- NCT07358182
- Testing
- Trastuzumab-rezetecan Treatment Group
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer
This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Locally Advanced Breast Carcinoma
- Trial name
- NCT07137416
- Testing
- Biopsy Procedure, Biospecimen Collection, Echocardiography Test
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- National Cancer Institute (NCI)
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
Locally Advanced Breast Cancer (LABC)
Pyrotinib Maleate Tablets in Combination With Dalpiciclib Isethionate Tablets and Standard Endocrine Therapy
This study is a prospective, exploratory clinical study design, and plans to enroll 33 patients with HR+HER2 low expression breast cancer who received pyrotinib combined with darcili and standard endocrine neoadjuvant therapy to…
- Trial name
- NCT07189884
- Testing
- Pyrotinib Maleate Tablets + Dalpiciclib Isethionate Tablets + Standard Endocrine
- Volunteers
- 33 people
- Sponsor
- The First Affiliated Hospital of Xiamen University
Breast Neoplasms
Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy, safety and tolerability of RC48-ADC with JS001 compared with RC48-ADC in endocrine-resistant hormone receptor (HR) positive, human epidermal growth factor receptor (HER)2-low advanced breast…
- Trial name
- NCT06105008
- Testing
- Disitamab Vedotin, Toripalimab
- Where
- 3 sites in China
- Sponsor
- RemeGen Co., Ltd.