Clinical trials: HER2-positive
Receptors, Estrogen, Genes, Erbb-2
A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer
The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2…
- Conditions
- Receptors, Estrogen, Genes, Erbb-2, Breast Neoplasms
- Trial name
- NCT04288089
- Testing
- Palbociclib (75, 100, 125 milligram [mg]), H3B-6545 (150, 300, 450 mg)
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 31 people
- Sponsor
- Eisai Inc.
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Evaluation of HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2BREASTDX
To prospectively evaluate the impact of HER2DX on the decision-making processes of the treating physicians and especially among the routine multidisciplinary tumour board, in defining type and setting of systemic therapy…
- Trial name
- HER2BREASTDX (NCT06723990)
- Testing
- Neoadjuvant standard treatment for HER2+, Adjuvant standard treatment for HER2+
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- European Institute of Oncology
Breast Cancer, HER2-positive Breast Cancer
HER2 Vaccine for Locally Advanced Breast Cancer
The goal of this study is to test an investigational vaccine to activate the immune system to fight breast cancer.
- Trial name
- NCT06949410
- Testing
- HER2 Vaccine
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Pravin T.P Kaumaya
Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer
Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors
The objective of this study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M17D1 in patients with HER2-Expressing or HER2-Mutant Advanced or Metastatic Solid Tumors.
- Conditions
- Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer, Unresectable Breast Carcinoma, Her2-Positive
- Trial name
- NCT06714617
- Testing
- BL-M17D1
- Where
- 9 sites in United States
- Volunteers
- 3 people
- Sponsor
- SystImmune Inc.
Breast Cancer (Early Breast Cancer)
A Prospective, Open-label, Randomized Trial Comparing Switch to A1811 Versus Continued THP Neoadjuvant Therapy After THP Induction in HER2-Positive Breast Cancer
This is a multicenter, open-label, randomized controlled trial. A total of 432 eligible patients with HER2-positive breast cancer will be enrolled after screening.
- Trial name
- SwithADC (NCT07844291)
- Testing
- A1811, THP
- Volunteers
- 432 people
- Sponsor
- Peking University People's Hospital
Advanced Solid Tumors, Lymphoma
FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors
FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance.
- Conditions
- Advanced Solid Tumors, Lymphoma, Gastric Cancer, Colorectal Cancer
- Trial name
- NCT03841110
- Testing
- FT500, Nivolumab, Pembrolizumab
- Where
- 4 sites in United States
- Volunteers
- 37 people
- Sponsor
- Fate Therapeutics
HER-2 Protein Overexpression, HER-2 Gene Amplification
Trastuzumab Biosimilar (Samfenet®) Plus Treatment of Physician's Choice (TPC) in Patients With HER2-positive Solid Tumor
HER2 signaling pathway abnormalities or HER2 overexpression can be seen in various types of solid tumors apart from breast cancer or hepatic cancer.
- Trial name
- BIOs-Her (NCT04215159)
- Testing
- Trastuzumab biosimilar, Gemcitabine Hydrochloride, Irinotecan Hydrochloride
- Volunteers
- 42 people
- Sponsor
- Jin-Hee Ahn
Gastric Cancer
A Study of Herceptin (Trastuzumab) in Combination With Standard Chemotherapy in Patients With HER Positive Metastatic Gastric Cancer
This open-label, multi-center study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with standard chemotherapy as first-line treatment in patients with HER2 positive metastatic adenocarcinoma of…
- Trial name
- NCT01260194
- Testing
- trastuzumab [Herceptin]
- Where
- 6 sites in India
- Volunteers
- 4 people
- Sponsor
- Hoffmann-La Roche
HER-2 Positive Colorectal Cancer
A Study of Pyrotinib Combined With Capecitabine for Metastatic HER-2 Positive Colorectal Cancer
To evaluate the efficacy and safety of pyrotinib combined with capecitabine in patients with metastatic her-2 positive colorectal cancer after standard treatment.
- Trial name
- NCT04227041
- Testing
- Pyrotinib in combination with capecitabine
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Qingdao Zhixin Health Technology Co., Ltd.
HER2-positive Breast Cancer, Stage III Ovarian Epithelial Cancer
Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2 Positive Stage III-IV Breast Cancer or Ovarian Cancer
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood.
- Conditions
- HER2-positive Breast Cancer, Stage III Ovarian Epithelial Cancer, Stage III Ovarian Germ Cell Tumor, Stage IIIA Breast Cancer
- Trial name
- NCT00436254
- Testing
- pNGVL3-hICD vaccine, sargramostim, flow cytometry
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- University of Washington
Breast Cancer
A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients
This is an open-label, Phase 1b dose escalation and expansion study to determine the maximum tolerated dose (MTD) of OP-1250 in combination with palbociclib (Ibrance®️, Pfizer Inc.).
- Trial name
- NCT05266105
- Testing
- Palazestrant, Palbociclib
- Where
- 8 sites in Australia
- Volunteers
- 60 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Breast Cancer
AryoTrust® (Trastuzumab) Safety Study
This study was a phase IV, observational, multicenter, single-arm, open-label, post-marketing surveillance study for the assessment of AryoTrust safety in Iranian HER2-positive breast cancer patients undergoing adjuvant…
- Trial name
- NCT06021379
- Testing
- Trastuzumab
- Where
- 15 sites in Iran
- Volunteers
- 597 people
- Sponsor
- AryoGen Pharmed Co.
Breast Neoplasms, Neoplasm Metastasis
A Study of Abemaciclib in Indian Women With Advanced Breast Cancer
The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with hormone therapy in Indian women with advanced breast cancer.
- Trial name
- NCT04707196
- Testing
- Abemaciclib, Nonsteroidal Aromatase Inhibitor (NSAI), Fulvestrant
- Where
- 15 sites in India
- Volunteers
- 200 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of pyrotinib in women with early stage high-risk breast cancer after adjuvant trastuzumab.
- Trial name
- NCT03980054
- Testing
- Pyrotinib
- Where
- China
- Volunteers
- 2,135 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Esophagogastric Adenocarcinoma
Platform Trial Evaluating Treatment of Neoadjuvant Trastuzumab-deruxtecan Containing Combination Therapies for HER2+, Resectable Esophagogastric Adenocarcinoma
The study is a phase Ib/II, prospective, single arm, open label, non-randomized, multi-center platform trial assessing the feasibility and safety of different neoadjuvant trastuzumab-deruxtecan containing combinational treatment…
- Trial name
- NeoART (NCT06731803)
- Testing
- Trastuzumab deruxtecan + 5FU/LV, Trastuzumab deruxtecan + FLO
- Where
- 14 sites in Austria, Germany
- Volunteers
- 36 people
- Sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Breast Cancer
A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)
This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and placebo in postmenopausal women with estrogen…
- Trial name
- NCT02273973
- Testing
- Letrozole, Taselisib
- Where
- 117 sites in United States, Australia and 20 more
- Volunteers
- 334 people
- Sponsor
- Genentech, Inc.
Tubular Breast Cancer Stage II, Mucinous Breast Cancer Stage II
Addition of Carboplatin to Neoadjuvant Therapy for Triple-negative and HER2-positive Early Breast Cancer
Study participants with primary breast cancer will receive a standard chemotherapy with an anthracycline and a taxane as well as trastuzumab in case of HER2-positive tumors at doses and duration in concordance to current…
- Conditions
- Tubular Breast Cancer Stage II, Mucinous Breast Cancer Stage II, Breast Cancer Female NOS, Invasive Ductal Breast Cancer
- Trial name
- GeparSixto (NCT01426880)
- Testing
- Carboplatin, background treatment
- Where
- 3 sites in Germany
- Volunteers
- 595 people
- Sponsor
- GBG Forschungs GmbH
HER2-positive Breast Cancer, HER2-positive Carcinoma
Margetuximab Expanded Access Program
The purpose of the Expanded Access program is to provide margetuximab to patients with pretreated HER2+ breast cancer for whom potential benefit justifies potential treatment risks.
- Trial name
- NCT03133988
- Testing
- Margetuximab
- Sponsor
- TerSera Therapeutics LLC
Advanced/Metastatic HER2-positive Breast, Gastric, Gastroesophageal Junction Cancer With Disease Progression Following Anti-HER2 Standard of Care Treatment
A Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/Metastatic HER2-Positive Breast, Gastric, and Gastro-Esophageal Junction (GEJ) Cancer
This is a Phase 1/2 multi-center, open label, dose escalation and dose expansion study to evaluate safety, tolerability, dosimetry, pharmacodynamics (PD), and efficacy of the targeted radionuclide therapeutic CAM-H2 in patients…
- Trial name
- NCT04467515
- Testing
- CAM-H2
- Where
- 12 sites in United States, Canada
- Volunteers
- 13 people
- Sponsor
- Precirix
Breast Cancer
Study With Atezolizumab in Combination With Trastuzumab and Vinorelbine in HER2-positive Advanced/Metastatic Breast Cancer
Immune checkpoint inhibitors given in monotherapy in advanced breast cancer have shown modest benefit in first-line, but very limited efficacy in later lines. Thus, combination therapies are needed.
- Trial name
- ATREZZO (NCT04759248)
- Testing
- Atezolizumab + Trastuzumab + Vinorelbine
- Where
- 15 sites in Spain
- Volunteers
- 55 people
- Sponsor
- SOLTI Breast Cancer Research Group
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