Clinical trials: Trastuzumab
Breast Cancer
A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)
This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the…
- Trial name
- NCT01772472
- Testing
- trastuzumab, trastuzumab emtansine
- Where
- 268 sites in United States, Argentina and 26 more
- Volunteers
- 1,486 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Breast Neoplasms
A Study to Compare PK, Immunogenicity and Safety of Trastuzumab of Incepta Pharmaceuticals Ltd With Trastuzumab (Roche)
Trastuzumab is an Ig G1 kappa, humanized monoclonal antibody which is most abundant subclass of IgG, that works against overexpress of HER2 (Human Epidermal Growth Factor Receptor Type 2).
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Disease, Antineoplastic Agents
- Trial name
- NCT06886659
- Testing
- Trastuzumab (proposed Trastuzumab biosimilar), Herclon
- Where
- 2 sites in Bangladesh
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Incepta Pharmaceuticals Ltd
HER2 Mutant Non-small Cell Lung Cancer, HER2-positive Metastatic Breast Cancer
ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer
The goal of this clinical trial is to test ELVN-002 in people with cancers that have an abnormal HER2 gene. The main question the trial aims to answer is if ELVN-002 is safe and tolerable at different doses.
- Conditions
- HER2 Mutant Non-small Cell Lung Cancer, HER2-positive Metastatic Breast Cancer, HER2 Gene Mutation, HER2 Amplification
- Trial name
- HER2 (NCT05650879)
- Testing
- ELVN-002, Fam-Trastuzumab Deruxtecan-Nxki, Trastuzumab emtansine
- Where
- 39 sites in United States, Australia and 5 more
- Volunteers
- 198 people
- Sponsor
- Enliven Therapeutics
Breast Cancer
A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug.
- Trial name
- NCT03248492
- Testing
- DS-8201a
- Where
- 99 sites in United States, Belgium and 7 more
- Volunteers
- 253 people
- Sponsor
- Daiichi Sankyo
Advanced or Metastatic Breast Cancer
MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer
The main purpose of this open-label, dose-escalation, phase Ib study is to identify the appropriate dose of MEN1611 to be used in combination with Trastuzumab with/without Fulvestrant for the treatment of advanced or metastatic…
- Trial name
- B-PRECISE-01 (NCT03767335)
- Testing
- MEN1611, Trastuzumab, Fulvestrant
- Where
- 27 sites in United States, Belgium and 4 more
- Volunteers
- 62 people
- Sponsor
- Menarini Group
HER2-positive Breast Cancer
Treatment Protocol of Tucatinib With Capecitabine and Trastuzumab in Patients With Unresectable Previously Treated HER2+ Breast Cancer
The purpose of this program is to provide access to tucatinib in the United States before FDA approval. Participants will receive a combination treatment of capecitabine, trastuzumab, and tucatinib.
- Trial name
- NCT04220203
- Testing
- Tucatinib, Capecitabine, Trastuzumab
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Breast Cancer
A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer
This Phase III trial adopts a randomized, open label, positive drug control, and multicenter trial design. Subjects who meet the criteria are randomly divided into 1:1 groups and receive treatment with TQB2102 injection or…
- Trial name
- NCT07003074
- Testing
- TQB2102 for Injection, Docetaxel combined + Trastuzumab +Pertuzumab
- Where
- 25 sites in China
- Volunteers
- 642 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
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
Gastric Cancer, Gastroesophageal Junction Cancer
Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
This is a Phase 2/3, randomized, open-label study for the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer conducted in two parts.
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer, HER2-positive Gastric Cancer
- Trial name
- MAHOGANY (NCT04082364)
- Testing
- margetuximab, Retifanlimab, Tebotelimab
- Where
- 73 sites in United States, China and 7 more
- Volunteers
- 82 people
- Sponsor
- MacroGenics
HER2-positive Gastric Cancer
JSKN003 Combined Treatment of HER2-positive Gastric Cancer
This study is designed to evaluate the safety and efficacy of JSKN003 combination therapy as first-line treatment in HER2-positive unresectable locally advanced or metastatic gastric cancer or resectable gastric cancer.
- Trial name
- NCT06998771
- Testing
- JSKN003, KN026, Capecitabine
- Volunteers
- 153 people
- Sponsor
- Shanghai JMT-Bio Inc.
Non-Small Cell Lung Cancer
DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer
The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants.
- Trial name
- DESTINY-Lung01 (NCT03505710)
- Testing
- Trastuzumab deruxtecan
- Where
- 21 sites in United States, France and 3 more
- Volunteers
- 181 people
- Sponsor
- Daiichi Sankyo
First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer
Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
This is a randomized, controlled, open-label, multicenter, phase Ш clinical study designed to compare the efficacy and safety of KN026 in combination with HB1801 to trastuzumab in combination with pertuzumab and docetaxel in the…
- Trial name
- NCT05838066
- Testing
- Recombinant Humanized Bispecific antibody against HER2，KN026, HB1801, Pertuzumab
- Where
- China
- Volunteers
- 880 people
- Sponsor
- Shanghai JMT-Bio Inc.
Breast Cancer
Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil
A national, multicenter, retrospective, observational study (Real-World Evidence-RWE) aimed to assess the efficacy of Trastuzumab-deruxtecan (T-DXd) in patients with triple-negative (RE<10%) metastatic HER2-Low breast cancer.
- Trial name
- NCT06231693
- Testing
- Trastuzumab deruxtecan
- Where
- 2 sites in Brazil
- Volunteers
- 2 people
- Sponsor
- AstraZeneca
HER2 Amplified, Advanced Breast Cancer
A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer
The purpose of this study was to evaluate the efficacy of enzalutamide with trastuzumab in patients with HER2+ AR+ metastatic or locally advanced breast cancer.
- Conditions
- HER2 Amplified, Advanced Breast Cancer, Human Epidermal Growth Factor Receptor 2 (HER2)
- Trial name
- NCT02091960
- Testing
- Enzalutamide, Trastuzumab
- Where
- 39 sites in United States, Belgium and 4 more
- Volunteers
- 103 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Adenocarcinoma Gastric Stage IV With Metastases, Adenocarcinoma - GEJ
DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)
This study will find out if trastuzumab deruxtecan is safe and works for participants with gastric or gastroesophageal junction cancer.
- Trial name
- NCT04014075
- Testing
- Trastuzumab deruxtecan
- Where
- 37 sites in United States, Belgium and 3 more
- Volunteers
- 79 people
- Sponsor
- Daiichi Sankyo
Breast Cancer Metastatic
DZD1516 in Combination With Trastuzumab and Capecitabine, or in Combination With T-DM1, in Patients With Metastatic HER2 Positive Breast Cancer
DZD1516 is an oral, blood brain barrier penetrable, selective HER2 tyrosine kinase inhibitor. This study is designed to evaluate the safety and tolerability of DZD1516 in patients with metastatic HER2 positive breast cancer who…
- Trial name
- NCT04509596
- Testing
- DZD1516 mono therapy in Part A, DZD1516 in combination with trastuzumab and/or capecitabine in Part B, DZD1516 in combination with T-DM1 in Part C
- Where
- 3 sites in United States, China
- Volunteers
- 23 people
- Sponsor
- Dizal Pharmaceuticals
Unrespectable Locally Advanced and or Metastatic HER2 Positive Breast Cancer Participants
JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer
This study is designed to compare the safety and efficacy of JSKN003 versus T-DM1 in unrespectable locally advanced and/or metastatic HER2-positive breast cancer participants previously treated with trastuzumab and taxane.
- Trial name
- NCT06846437
- Testing
- JSKN003, Trastuzumab emtansine (T-DM1)
- Where
- China
- Volunteers
- 228 people
- Sponsor
- Shanghai JMT-Bio Inc.
Neoplasms, Breast
ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D
This was a four-arm (parallel group) randomized, open-label, multicenter Phase 3 study to investigate the use of a combination of Lapatinib and Trastuzumab, a sequence of Trastuzumab followed by Lapatinib, and Lapatinib alone…
- Trial name
- ALTTO (NCT00490139)
- Testing
- Lapatinib, Trastuzumab
- Where
- 924 sites in United States, Argentina and 42 more
- Volunteers
- 8,381 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer
This was a multi-center, multinational, randomized, open-label, Phase III study comparing combination taxane-based chemotherapy plus lapatinib to combination taxane-based chemotherapy plus trastuzumab in women with documented…
- Trial name
- NCT00667251
- Testing
- trastuzumab, docetaxel, lapatinib ditosylate
- Where
- 257 sites in United States, Argentina and 19 more
- Volunteers
- 652 people
- Sponsor
- Novartis Pharmaceuticals
HER-2 Positive Breast Cancer, Metastatic Neoplasm
Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer
The purpose of this study is to determine whether patients with metastatic breast cancer treated with margetuximab plus chemotherapy have longer progression free survival (PFS) and overall survival (OS) than patients treated with…
- Trial name
- SOPHIA (NCT02492711)
- Testing
- Margetuximab, Trastuzumab, Physician's choice of chemotherapy.
- Where
- 167 sites in United States, Austria and 16 more
- Volunteers
- 624 people
- Sponsor
- MacroGenics