Clinical trials: HER2 Low Breast Carcinoma
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
HER2-negative
NIS Study Determining Prevalence of HER2-low in Metastatic Breast Cancer Patients
This noninterventional, multicenter,retrospective study has been proposed to estimate the prevalence, clinicopathological characteristics,treatment patterns and clinical outcomes of human epidermal growth factor receptor 2…
- Trial name
- iRetroBC (NCT06131424)
- Where
- 31 sites in Argentina, Brazil and 11 more
- Volunteers
- 1,151 people
- Sponsor
- AstraZeneca
Breast Cancer
Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before.
- Trial name
- NCT03734029
- Testing
- Trastuzumab deruxtecan (DS-8201a), Capecitabine, Eribulin
- Where
- 208 sites in United States, Austria and 18 more
- Volunteers
- 557 people
- Sponsor
- Daiichi Sankyo
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.
Breast Cancer
Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax
The study will be a multi-center, prospective, randomized, single-blinded, placebo-controlled Phase II trial of Herceptin + NeuVax(TM) vaccine (E75 peptide/granulocyte macrophage-colony stimulating factor) (GM-CSF) versus…
- Trial name
- NCT01570036
- Testing
- Herceptin, NeuVax vaccine, GM-CSF
- Where
- 29 sites in United States
- Volunteers
- 275 people
- Sponsor
- George E. Peoples
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
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 Neoplasms, Breast Cancer
PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan
This is a prospective non-interventional, multicenter study observing patient reported outcomes as well as real-world efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with documented Human epidermal growth factor…
- Conditions
- Breast Neoplasms, Breast Cancer, Neoplasm Metastasis
- Trial name
- PROVIDENCE (NCT05573893)
- Where
- 109 sites in Germany
- Volunteers
- 800 people
- Sponsor
- AstraZeneca
Breast Cancer
A Study of Pertuzumab in Participants With Metastatic Breast Cancer
This study will evaluate the efficacy and safety of pertuzumab (rhuMAb 2C4) in participants with metastatic breast cancer which has progressed during or after standard chemotherapy and which is not amenable to curative therapy.
- Trial name
- NCT02491892
- Testing
- Pertuzumab
- Where
- 18 sites in Australia, Belgium and 6 more
- Volunteers
- 79 people
- Sponsor
- Hoffmann-La Roche
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
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.
Breast Neoplasms, Breast Cancer
Safety and Efficacy Study of the Trifunctional Antibody Ertumaxomab to Treat Patients With Advanced or Metastatic Breast Cancer
The purpose of this study is to determine the safety and efficacy of the investigational trifunctional anti-Her-2/neu x anti-CD3 antibody ertumaxomab as treatment for hormone therapy refractory Her-2/neu 1+ or 2+ expressing…
- Trial name
- IV REXBC 02 (NCT00351858)
- Testing
- ertumaxomab
- Where
- Belgium
- Volunteers
- 40 people
- Sponsor
- Neovii Biotech
HER2-low Hormone Receptor Positive Breast Cancer
A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients
This is a Phase II Study of HLX22 in Combination with Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression or Intolerable Adverse…
- Trial name
- NCT06832202
- Testing
- HLX22, Trastuzumab Deruxtecan
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Shanghai Henlius Biotech
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
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
- 555 sites in United States, Argentina and 26 more
- Volunteers
- 4,556 people
- Sponsor
- Stemline Therapeutics, Inc.
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
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
UNFOLD Study Egypt
Breast cancer is a major public health concern worldwide. In Egypt, it was the most diagnosed cancer among females in 2020 with an incidence rate of 32.4%.
- Trial name
- NCT06188494
- Where
- 7 sites in Egypt
- Volunteers
- 405 people
- Sponsor
- AstraZeneca
Advanced or Metastatic Breast Cancer
A Study of MRG002 in the Treatment of Patients With HER2-low Locally Advanced or Metastatic Breast Cancer (BC)
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-low locally advanced or metastatic BC.
- Trial name
- NCT04742153
- Testing
- MRG002
- Where
- 2 sites in China
- Volunteers
- 66 people
- Sponsor
- Shanghai Miracogen Inc.
Breast Cancer
A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer
This trial is a randomized, open-label, multicenter Phase II study designed to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally recurrent or metastatic HR-positive, HER2-low expressing breast…
- Trial name
- NCT07678957
- Testing
- BL-M07D1, DS-8201
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.