Clinical trials: HER2 + Breast Cancer
Breast Cancer
Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer
The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus observation/no Herceptin) in women with HER2-overexpressing primary breast cancer who have completed (neo-)adjuvant systemic…
- Trial name
- HERA (NCT00045032)
- Testing
- Herceptin
- Where
- 203 sites in Argentina, Australia and 31 more
- Volunteers
- 5,099 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Efficacy and Safety of Trastuzumab Emtansine in Chinese Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer
This is a Phase III, randomized, multicenter, two-arm, open-label study designed to evaluate the safety and efficacy of trastuzumab emtansine compared with that of lapatinib + capecitabine in Chinese participants with…
- Trial name
- NCT03084939
- Testing
- Trastuzumab Emtansine, Lapatinib, Capecitabine
- Where
- 18 sites in China
- Volunteers
- 351 people
- Sponsor
- Hoffmann-La Roche
HER2-negative Breast Cancer
A Study to Investigate the Biological Effects of AZD9833 in Women With ER-positive, HER2 Negative Primary Breast Cancer
This is a randomised, open-label, parallel-group, pre-surgical study aimed to investigate the biological effects, safety, tolerability, and pharmacokinetics (PK) of different doses of oral AZD9833 in post-menopausal women with…
- Trial name
- SERENA-3 (NCT04588298)
- Testing
- AZD9833
- Where
- 12 sites in Georgia, Mexico and 1 more
- Volunteers
- 135 people
- Sponsor
- AstraZeneca
Breast Cancer
A Study to Assess Preference for Subcutaneous Trastuzumab Treatment in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Metastatic Breast Cancer Responding to First-Line Intravenous Trastuzumab for at Least 3 Years
This open-label, randomized, multicenter study will evaluate participant preference for subcutaneous (SC) versus intravenous (IV) trastuzumab (Herceptin) in participants with HER2-positive metastatic breast cancer responding to…
- Trial name
- NCT01810393
- Testing
- Trastuzumab
- Where
- 61 sites in France
- Volunteers
- 114 people
- Sponsor
- Hoffmann-La Roche
Solid Tumor, Microsatellite Instability-High (MSI-H) Solid Tumors
A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors
The main purpose of this study is to evaluate the safety and tolerability of anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody LY3300054 in participants with advanced refractory solid tumors.
- Conditions
- Solid Tumor, Microsatellite Instability-High (MSI-H) Solid Tumors, Cutaneous Melanoma, Pancreatic Cancer
- Trial name
- PACT (NCT02791334)
- Testing
- LY3300054, Ramucirumab, Abemaciclib
- Where
- 14 sites in United States, Belgium and 5 more
- Volunteers
- 164 people
- Sponsor
- Eli Lilly and Company
Breast Neoplasms
Sapanisertib in Combination With Fulvestrant in Women With Advanced or Metastatic Breast Cancer After Aromatase Inhibitor Therapy
The primary purpose of this study is to compare the progression free survival (PFS) of participants treated with the combination of fulvestrant plus daily sapanisertib and fulvestrant plus weekly sapanisertib versus participants…
- Trial name
- NCT02756364
- Testing
- Fulvestrant, Sapanisertib
- Where
- 53 sites in United States, Spain
- Volunteers
- 141 people
- Sponsor
- Calithera Biosciences, Inc
Breast Cancer
Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study
TOL2506A (OVELIA) is a Phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 in suppressing ovarian function in premenopausal women with HR+, HER2-negative breast cancer and men with HR+ breast cancer.
- Trial name
- NCT05645536
- Testing
- TOL2506, Tamoxifen, Letrozole tablets
- Where
- 46 sites in United States, Argentina and 4 more
- Volunteers
- 250 people
- Sponsor
- Tolmar Inc.
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
A Study of Subcutaneous At Home Administration of Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2-positive (HER2+) Early Breast Cancer (eBC)
This single arm, multicenter study will evaluate the safety of assisted subcutaneous administration of trastuzumab in participants with HER2+ eBC.
- Trial name
- NCT01926886
- Testing
- Trastuzumab
- Where
- 23 sites in Belgium, Israel
- Volunteers
- 102 people
- Sponsor
- Hoffmann-La Roche
Breast Neoplasms, Breast Cancer
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.
- Conditions
- Breast Neoplasms, Breast Cancer, HER2-positive Early Breast Cancer
- Trial name
- NCT05113251
- Testing
- Trastuzumab Deruxtecan, Paclitaxel, Trastuzumab
- Where
- 145 sites in United States, Brazil and 16 more
- Volunteers
- 927 people
- Sponsor
- AstraZeneca
Breast Cancer
A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies Prosigna Gene Signature Assay
The primary objective of this study is to assess the extent to which the Prosigna™ Breast Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and…
- Trial name
- NCT01899079
- Where
- 7 sites in Spain
- Volunteers
- 217 people
- Sponsor
- NanoString Technologies, Inc.
Breast Cancer, Metastatic Breast Cancer
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with FGF aberrant metastatic breast cancer, as well as in the treatment of patients with biomarker negative (FGF…
- Conditions
- Breast Cancer, Metastatic Breast Cancer, MBC, HER2 Positive
- Trial name
- NCT02202746
- Testing
- Lucitanib
- Where
- 33 sites in United States
- Volunteers
- 178 people
- Sponsor
- Clovis Oncology, Inc.
Neoplasms, Breast
GW572016 Combined With Trastuzumab For The Treatment Of Previously Trastuzumab-Treated Breast Cancer
This is two-part study (Phase I/Phase II). Part I is designed to find the optimal (best) doses of GW572016 and trastuzumab when given together,Part II is designed to evaluate the tumor response rate (shrinkage or lack of growth)…
- Trial name
- NCT00371488
- Testing
- GW572016 oral tablets
- Where
- 2 sites in Japan
- Volunteers
- 11 people
- Sponsor
- GlaxoSmithKline
Breast Cancer, Gastric Cancer
A Clinical Trial of the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors
This clinical trial will enroll subjects with HER2+ solid tumors and is conducted in two phases. The primary objective of Phase 1 is to determine the safety and tolerability of AB-201 in subjects with advanced HER2+ solid tumors.
- Conditions
- Breast Cancer, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- Trial name
- NCT05678205
- Testing
- AB-201, Cyclophosphamide, Fludarabine
- Where
- 2 sites in United States, South Korea
- Sponsor
- Artiva Biotherapeutics, Inc.
HER2-positive Breast Cancer
A Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients of China With HER2-positive Unresectable or Metastatic Breast Cancer
This is a multicenter, non-interventional, retrospective, real-world study that enrolled patients diagnosed with HER2-positive unresectable or metastatic breast cancer.
- Trial name
- NCT05769751
- Testing
- Electronic medical record and hospital information system or other available resources
- Where
- 5 sites in China
- Volunteers
- 865 people
- Sponsor
- Daiichi Sankyo
Melanoma, Renal Cell Carcinoma
A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors
In this four-part study, NKTR-214 was administered in combination with nivolumab and with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 + nivolumab) doses to determine the RP2D.
- Conditions
- Melanoma, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Urothelial Carcinoma
- Trial name
- PIVOT-02 (NCT02983045)
- Testing
- Dose Escalation Doublet: Combination of NKTR-214 + nivolumab, Dose Expansion Doublet: Combination of NKTR-214 + nivolumab, Schedule Finding Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab
- Where
- 58 sites in United States, Belgium and 6 more
- Volunteers
- 557 people
- Sponsor
- Nektar Therapeutics
Breast Cancer
A Trial of HRS-6209-205 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Combination Therapy in Subjects With HR-Positive/HER2-Negative Cancer
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects with HR-Positive/HER2-Negative solid tumor.
- Trial name
- NCT07358377
- Testing
- HRS-6209 Capsules and fulvestrant injection
- Where
- 6 sites in Australia
- Volunteers
- 15 people
- Sponsor
- Atridia Pty Ltd.
Breast Neoplasms, Breast Cancer
Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)
Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts…
- Trial name
- NCT06686394
- Testing
- Patritumab deruxtecan, Trastuzumab, Trastuzumab Biosimilar
- Where
- 18 sites in United States, Canada and 4 more
- Volunteers
- 181 people
- Sponsor
- Merck Sharp & Dohme LLC
HER2-positive Breast Cancer
Molecular Pathway Activation Markers Predicting Efficacy of Trastuzumab Therapy for HER2-positive Breast Cancer
The purpose of the study is to identify molecular markers at the level of molecular pathway activation to predict efficacy of anti-HER2 therapy with Trastuzumab.
- Trial name
- NCT03521245
- Testing
- RNA sequencing, Transcriptome analysis, Trastuzumab
- Where
- 4 sites in United States, Russia
- Volunteers
- 40 people
- Sponsor
- OmicsWay Corp.
Malignant Neoplasm of Breast
Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Trastuzumab (AryoTrust) Versus Herceptin® in Breast Cancer
This is A Phase III, randomized, two-armed, patient-outcome assessor-data analyzer blinded, parallel active controlled non-Inferiority clinical trial study to evaluate efficacy and safety of AryoTrust (Aryogen Trastuzumab in…
- Trial name
- NCT03425656
- Testing
- Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
- Where
- 19 sites in Iran
- Volunteers
- 108 people
- Sponsor
- AryoGen Pharmed Co.
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