Clinical trials: HER2-positive
Breast Cancer Stage IV
Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management
This is an open-label, single arm, non-randomized, multicenter, phase 2 study assessing the efficacy and safety of T-DXd as first-line treatment in HER2-positive advanced/metastatic BC patients (N=300).
- Trial name
- TOP-REAL (NCT07371585)
- Testing
- Digital Health Tools, T-DXd, Pertuzumab
- Where
- 27 sites in France, Germany and 1 more
- Volunteers
- 300 people
- Sponsor
- SOLTI Breast Cancer Research Group
HER2 Low Breast Carcinoma
A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer
HR-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk…
- Trial name
- NCT05911958
- Testing
- SHR-A1811 for injection
- Where
- China
- Volunteers
- 66 people
- Sponsor
- Henan Cancer Hospital
HER2 Positive Breast Carcinoma, Recurrent Breast Carcinoma
4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer
This trial studies the best dose and side effects of utomilumab (4-1BB agonist monoclonal antibody PF-05082566) with trastuzumab emtansine or trastuzumab in treating patients with HER2-positive breast cancer that has spread to…
- Conditions
- HER2 Positive Breast Carcinoma, Recurrent Breast Carcinoma, Stage III Breast Cancer, Stage IIIA Breast Cancer
- Trial name
- NCT03364348
- Testing
- Utomilumab, Trastuzumab, Ado-Trastuzumab Emtansine
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- George W. Sledge Jr.
Metastatic Breast Cancer
Τreatment Standards and Outcomes of Patients With ER/PR Positive, HER2-negative Metastatic Breast Cancer
To capture the treatment patterns and clinical characteristics of patients with ER/PR positive, HER2-negative MBC in Greece
- Trial name
- MBC (NCT04247035)
- Where
- Greece
- Volunteers
- 300 people
- Sponsor
- Hellenic Society of Medical Oncology
Colorectal Cancer, Metastatic Colorectal Adenocarcinoma
Dual-Targeting CAR-NK Cells in Biomarker-Selected Advanced Colorectal Cancer
This Phase 1/2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of an allogeneic dual-target chimeric antigen receptor natural killer (CAR-NK) cell product in adults with advanced or metastatic…
- Conditions
- Colorectal Cancer, Metastatic Colorectal Adenocarcinoma, Unresectable Colorectal Cancer
- Trial name
- DUO-CRC-NK-111 (NCT07589517)
- Testing
- EB-DUO-CAR-NK-CEA/GCC, Lymphodepletion
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Beijing Biotech
Breast Cancer
(Oncotype DX®) in Estrogen Receptor Positive (ER+) HER-2 Negative (HER 2-) 1-3 Node Positive (pN1) Breast Cancer
This study is a multi-center BCCA study that evaluates the impact of the Oncotype DX® assay on the decision making of the treating physician and the patient.
- Trial name
- NCT02627703
- Testing
- Oncotype DX
- Where
- Canada
- Volunteers
- 80 people
- Sponsor
- British Columbia Cancer Agency
Breast Cancer Female, Breast Cancer
The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
The purpose of this study is to test the safety and effectiveness of a sequence of drugs (a Taxane plus Trastuzumab plus Pertuzumab followed by Trastuzumab Deruxtecan, followed by Tucatinib plus Ado-Trastuzumab Emtansine (T-DM1)…
- Conditions
- Breast Cancer Female, Breast Cancer, Breast Cancer Metastatic, Estrogen Receptor-positive Breast Cancer
- Trial name
- NCT06439693
- Testing
- Nab-Paclitaxel, Paclitaxel, Docetaxel
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Dana-Farber Cancer Institute
Estrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer
Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer
Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype.
- Conditions
- Estrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer, Advanced Breast Cancerv, Metastatic Breast Cancer
- Trial name
- NCT06062498
- Testing
- elacestrant, palbociclib, abemaciclib, ribociclib
- Where
- 3 sites in United States
- Volunteers
- 174 people
- Sponsor
- Northwestern University
Breast Neoplasms
A Study on Neoadjuvant Therapy for Her-2 Positive Breast Cancer and the Prognosis by Detecting CTCs
Docetaxel plus carboplatin and trastuzumab has been a standard treatment for patients with human epidermal growth factor receptor-2（HER-2）positive.
- Trial name
- NCT02510781
- Testing
- Epirubicin, Docetaxel, Trastuzumab
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Hospital Affiliated to Military Medical Science, Beijing
HER2-positive Breast Cancer, HER-2 Protein Overexpression
Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors
This is a Phase 1 first-in-human study of ORM-5029 in participants with HER2-expressing advanced solid tumors. The study consists of two parts: a Part 1 Dose Escalation and Part 2 Dose Expansion.
- Conditions
- HER2-positive Breast Cancer, HER-2 Protein Overexpression, HER-2 Gene Amplification, HER2 Gene Mutation
- Trial name
- NCT05511844
- Testing
- ORM-5029
- Where
- 11 sites in United States
- Volunteers
- 25 people
- Sponsor
- Orum Therapeutics USA, Inc.
Breast Cancer
A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib
This study was a companion study to CLEE011A2404 which provided the opportunity for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.
- Trial name
- NCT03050398
- Testing
- Ribociclib, letrozole
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer
BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer
This is a prospective, multi-center, open-label, single arm, phase II study with a 2-stage design and Bayesian interim monitoring to investigate the safety and efficacy of BEZ235 in patients with progressive metastatic HR+ HER2…
- Trial name
- NCT01288092
- Testing
- BEZ235
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1)
Keyriched-1 is a multicenter, interventional, prospective, single arm, open label, neoadjuvant phase II trial evaluating the pathological complete response (pCR) rate induced by pembrolizumab in combination with the dual…
- Trial name
- Keyriched-1 (NCT03988036)
- Testing
- Pembrolizumab, Trastuzumab Biosimilar ABP 980, Pertuzumab
- Where
- 12 sites in Germany
- Volunteers
- 46 people
- Sponsor
- Women's Cancer Study Group GmbH
Gastric Cancer, Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)
This study will evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with ramucirumab and paclitaxel (Ram + PTX) in participants with HER2-positive gastric or gastro-esophageal junction (GEJ) adenocarcinoma…
- Trial name
- NCT04704934
- Testing
- Trastuzumab deruxtecan, Ramucirumab, Paclitaxel
- Where
- 156 sites in Argentina, Belgium and 22 more
- Volunteers
- 490 people
- Sponsor
- Daiichi Sankyo
Metastatic Solid Tumor, Brain Metastases
A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB)
To learn if the study drugs, tucatinib and adotrastuzumab emtansine (T-DM1), can help to control solid tumors that have spread to the brain.
- Trial name
- NCT05673928
- Testing
- Trastuzumab emtansine, Tucatinib
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- M.D. Anderson Cancer Center
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers
This study is designed to assess the safety and preliminary activity of SBT6050 in combination with trastuzumab deruxtecan (Part 1) or tucatinib plus trastuzumab +/- capecitabine (Part 2).
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Colorectal Cancer, HER2-expressing Non-small Cell Lung Cancer
- Trial name
- NCT05091528
- Testing
- SBT6050, trastuzumab deruxtecan, tucatinib
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Silverback Therapeutics
Metastatic Breast Cancer
Phase 1b/2 Study of U3-1287 in Combination With Trastuzumab Plus Paclitaxel in Newly Diagnosed Metastatic Breast Cancer (MBC)
This is a Phase 1b/2 study. In Phase 1b portion, subjects will know the treatment they are receiving . Subjects will receive U3-1287 with trastuzumab plus paclitaxel .
- Trial name
- NCT01512199
- Testing
- U3-1287, Trastuzumab, Paclitaxel
- Where
- 8 sites in Argentina, Chile
- Volunteers
- 29 people
- Sponsor
- Daiichi Sankyo
Advanced Solid Tumors
Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors
This study is the first-in-human (Phase I/II) trial of SYS6045, a multicenter, open-label, dose-escalation and dose-expansion clinical study.
- Trial name
- NCT07122063
- Testing
- SYS6045
- Where
- China
- Volunteers
- 266 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Metastatic Breast Cancer, Progesterone Receptor Positive Tumor
A Randomised Study of Docosahexaenoic Acid (DHA) in Metastatic Breast Cancer
The aim of this study is to increase, by DHA-induced chemosensitization, the activity of anticancer chemotherapy in patients with a metastatic advanced breast cancer, by a nutritional approach with marin-derived PolyUnsaturated…
- Conditions
- Metastatic Breast Cancer, Progesterone Receptor Positive Tumor, Estrogen Receptor Positive Tumor, HER-2 Negative Tumor
- Trial name
- DHALYA (NCT01548534)
- Testing
- Dietary supplementation with fish oil., Dietary supplementation with vegetable oil
- Where
- 11 sites in France
- Volunteers
- 65 people
- Sponsor
- University Hospital, Tours
Anatomic Stage IV Breast Cancer AJCC v8, HER2 Positive Breast Carcinoma
T-DM1 With or Without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer
This phase II trial studies how well T-DMI with or without abemaciclib works for the treatment of HER2-positive breast cancer that has spread to other places in the body (metastatic).
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, HER2 Positive Breast Carcinoma, Metastatic Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8
- Trial name
- NCT04351230
- Testing
- Abemaciclib, Trastuzumab Emtansine
- Where
- 6 sites in United States
- Sponsor
- Academic and Community Cancer Research United
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