Clinical trials: HER2 Low Breast Cancer
Breast Cancer, Brain Metastases
ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in breast cancer patients with recurrent brain metastases.
- Trial name
- NCT02048059
- Testing
- ANG1005
- Where
- 19 sites in United States
- Volunteers
- 72 people
- Sponsor
- Angiochem Inc
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
HER2-low Breast Cancer
Disitamab Vedotin Plus Bevacizumab in HER2-Low Metastatic Breast Cancer After T-DXd Failure: A Phase II Study
This is a multicenter, single-arm, phase II clinical trial designed to evaluate the efficacy and safety of disitamab vedotin in combination with bevacizumab in patients with HER2-low advanced or metastatic breast cancer who have…
- Trial name
- NCT07446452
- Testing
- Disitamab Vedotin (RC48), Bevacizumab
- Where
- China
- Volunteers
- 37 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
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
Locally Advanced or Metastatic Breast Cancers
Study Aiming to Compare the Plasma Exposure of the Payload (Free-DXd) in Patients Treated by T-DXd for Locally Advanced or Metastatic Breast Cancer According to Their BMI.
This is a multicenter, prospective, non-randomized, open-label, pharmacokinetic study, aiming to compare the plasma exposure of the payload (free-DXd) in patients treated by T-DXd for locally advanced or metastatic breast cancer…
- Trial name
- TDXdose (NCT07195344)
- Testing
- Pharmacokinetics blood samples
- Where
- 10 sites in France
- Volunteers
- 210 people
- Sponsor
- Institut Claudius Regaud
Breast Cancer
Probability of OncotypeDx to Reallocate As Low or High Risk of Recurrence Breast Cancer Patients with Uncertain Biology
In some cases of hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative early breast cancer the benefit of adding adjuvant chemotherapy to hormonal treatment, estimated on the basis of the classical…
- Trial name
- NCT06363812
- Where
- Italy
- Volunteers
- 258 people
- Sponsor
- Fondazione Sandro Pitigliani
Breast Cancer
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative…
- Trial name
- ELEGANT (NCT06492616)
- Testing
- Elacestrant, Anastrozole, Letrozole
- Where
- 567 sites in United States, Argentina and 26 more
- Volunteers
- 4,220 people
- Sponsor
- Stemline Therapeutics, Inc.
Breast Cancer Metastatic, HER2-positive Metastatic Breast Cancer
Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd
ICARUS-BREAST02 is an open-label, multicenter, phase 1b/2, platform study that aims to evaluate the safety, tolerability, and efficacy of HER3-DXd monotherapy and in combination with other anti-cancer agents in patients with ABC.
- Conditions
- Breast Cancer Metastatic, HER2-positive Metastatic Breast Cancer, HER2 Low Breast Carcinoma, Advanced Breast Cancer
- Trial name
- ICARUSBREAST02 (NCT06298084)
- Testing
- Patritumab deruxtecan, Olaparib
- Where
- France
- Volunteers
- 152 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Breast Cancer, Metastatic Breast Cancer
Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC
The purpose of this research study is to see if the medication sacituzumab govitecan (SG) is effective at the currently approved dose and schedule in people who have previously received trastuzumab deruxtecan (T-DXd) for the…
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Hormone-receptor-positive Breast Cancer
- Trial name
- SERIES (NCT06263543)
- Testing
- Sacituzumab govitecan
- Where
- 3 sites in United States
- Volunteers
- 75 people
- Sponsor
- Reshma L. Mahtani, D.O.
HER2-positive Advanced Solid Tumor
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.
- Trial name
- NCT05150691
- Testing
- DB-1303/BNT323, Pertuzumab Injection, Ritonavir
- Where
- 102 sites in United States, Australia and 4 more
- Volunteers
- 796 people
- Sponsor
- DualityBio Inc.
HER2-positive Breast Cancer
Taxane Combined Targeted Therapy for Low-risk HER2 Positive and Lymph Node Negative Breast Cancer
Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and high risk of recurrence and metastasis.
- Trial name
- TaxHER (NCT06711055)
- Where
- China
- Volunteers
- 285 people
- Sponsor
- Shu Wang
Breast Cancer With Low to Intermediate HER2 Expression, Breast Cancer (Triple Negative Breast Cancer (TNBC))
Use of Magtrace Bracketing for Excision of Lesion and Sentinel Lymph Node Localization in Breast Conserving Surgery for Breast Cancer
Breast cancer is the commonest cancer affecting women worldwide. Early breast cancer is treated surgically with wide local excision of tumor with axillary staging operations like sentinel node biopsy.
- Conditions
- Breast Cancer With Low to Intermediate HER2 Expression, Breast Cancer (Triple Negative Breast Cancer (TNBC)), Breast Cancer (Triple Negative Type), Breast Cancer - Infiltrating Ductal Carcinoma
- Trial name
- MagBracket (NCT07844473)
- Testing
- Super paramagnetic iron oxide bracketing injection
- Where
- Saudi Arabia
- Volunteers
- 35 people
- Sponsor
- King Faisal Specialist Hospital & Research Center
Triple-Negative Breast Cancer
T-DXd in the First-Line Treatment of Locally Advanced or Metastatic TNBC-LAR HER2-low Patients
This is an open-label, single-arm phase II trial of first-line treatment with trastuzumab deruxtecan (T-DXd) for patients with locally advanced or metastatic triple-negative breast cancer, luminal androgen receptor subtype…
- Trial name
- NCT05953168
- Testing
- Trastuzumab Deruxtecan
- Where
- China
- Volunteers
- 69 people
- Sponsor
- Fudan University
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
HER 2 Low-expressing Breast Cancer
Correlation Study of Serum HER 2 Against HER 2-ADC Drug Efficacy in HER 2 Low-expressing Breast Cancer
Breast cancer is one of the most common malignancies in women worldwide, with HER2-positive breast cancer accounting for about 15-20% of all breast cancer cases.
- Trial name
- NCT06492447
- Testing
- Against HER 2-ADC Drug
- Volunteers
- 50 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
HER2-positive Breast Cancer, Breast Cancer
A Study of Skipping Radiation Therapy in People With Breast Cancer
The purpose of this study is to find out whether it is safe to skip (omit) radiation therapy to the breast after lumpectomy in people with low-risk HER2-positive breast cancer who are receiving HER2-targeted therapy.
- Trial name
- SuperHERO (NCT07895511)
- Testing
- HER2-targeted therapy, Tamoxifen, No Radiation Therapy
- Where
- 7 sites in United States
- Volunteers
- 136 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
HER2 Expressing Solid Tumors
Gene Therapy for HER-Positive Cancer (SENTRY-HER2)
This is a Phase 1/2, first-in-human, open-label, dose-escalating and expansion trial designed to assess the safety and efficacy of VNX-202 in patients with HER2 positive cancers.
- Trial name
- SENTRY-HER2 (NCT07192432)
- Testing
- Dose Level 1, VNX-202, Dose Level 2, VNX-202, Dose Level 3, VNX-202
- Where
- 11 sites in United States
- Volunteers
- 27 people
- Sponsor
- Vironexis Biotherapeutics Inc.
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2
A Study of XMT-2056 in advanced/recurrent solid tumors that express HER2.
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Non-Small Cell Lung Cancer, HER2-positive Colorectal Cancer
- Trial name
- NCT05514717
- Testing
- XMT-2056
- Where
- 14 sites in United States
- Volunteers
- 57 people
- Sponsor
- Day One Biopharmaceuticals, Inc.
Metastatic Breast Cancer
Sequencing SG vs. T-DXd in HER2-Low/TROP2-High Metastatic Breast Cancer
Currently, no phase III RCT has directly compared SG and T-DXd sequencing strategies, and the predictive role of biomarkers remains unclear. Additionally, there is no standard scoring system for Trop-2 expression.
- Trial name
- STORM (NCT07368543)
- Testing
- Sacituzumab Govitecan, Trastuzumab Deruxtecan
- Volunteers
- 216 people
- Sponsor
- Fudan University
HER2 Low Advanced or Metastatic Breast Cancer
A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
This study aims to evaluate the safety, tolerability, PK and preliminary anti-tumour activity of SHR-A1811 combined with other therapies in patients with HER2 low advanced or metastatic breast cancer.
- Trial name
- NCT05792410
- Testing
- SHR-A1811 & Dalpiciclib Isethionate Tablets, SHR-A1811 & Fulvestrant, SHR-A1811 & Bevacizumab injection
- Volunteers
- 300 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.