Clinical trials: HER2-positive
Her 2 Positive Breast Cancer, Breast Cancer Female
A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)
This research study is being done to evaluate the safety and effectiveness of sacituzumab govitecan with trastuzumab (Herceptin, Herceptin Hylecta, or trastuzumab biosimilar) in metastatic HER2+ breast cancer.
- Conditions
- Her 2 Positive Breast Cancer, Breast Cancer Female, Breast Cancer Metastatic
- Trial name
- NCT06100874
- Testing
- Sacituzumab Govitecan, Trastuzumab, Trastuzumab and Hyaluronidase-oysk
- Where
- 4 sites in United States
- Volunteers
- 28 people
- Sponsor
- Adrienne G. Waks
Biliary Tract or Colorectal Cancer With Her2-positive/Mutated
A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.
To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer.
- Trial name
- NCT06434597
- Testing
- SPH5030
- Where
- 30 sites in China
- Volunteers
- 60 people
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
Breast Cancer, Estrogen Receptor Positive Tumor
Durvalumab and Endocrine Therapy in ER+/Her2- Breast Cancer After CD8+ Infiltration Effective Immune-Attractant Exposure
This is an open-label, multicentric, international, phase II trial testing aromatase inhibitors in combination with durvalumab in patients with CD8+ T cell infiltration (>10% CD8+ T cells in the tumor).
- Conditions
- Breast Cancer, Estrogen Receptor Positive Tumor, Menopause, Hormone Antagonist
- Trial name
- ULTIMATE (NCT02997995)
- Testing
- Immune-attractant, Durvalumab, Biopsy
- Where
- 29 sites in France, Spain and 1 more
- Volunteers
- 61 people
- Sponsor
- UNICANCER
Breast Cancer
Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk…
- Trial name
- CheckMate 7FL (NCT04109066)
- Testing
- nivolumab, paclitaxel (PTX), anthracycline
- Where
- 240 sites in United States, Argentina and 30 more
- Volunteers
- 521 people
- Sponsor
- Bristol-Myers Squibb
Advanced Solid Tumor, Metastatic Solid Tumor
BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
This is an open-label, multicenter, phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-43395, a cyclin-dependent kinase 4 (CDK4)…
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Hormone-receptor-positive Breast Cancer, Breast Cancer
- Trial name
- NCT06253195
- Testing
- BGB-43395, Fulvestrant, Letrozole
- Where
- 7 sites in China
- Volunteers
- 33 people
- Sponsor
- BeOne Medicines
Unresectable Locally Recurrent Breast Cancer, Unresectable Locally Metastatic Breast Cancer
A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer
The study is designed to compare the efficacy and safety of different dose groups of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in patients with HR-positive, HER2-low unresectable locally recurrent/metastatic breast cancer.
- Trial name
- NCT07497386
- Testing
- Trastuzumab Rezetecan for Injection, Trastuzumab Deruxtecan for Injection
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer, HER2-positive Breast Cancer
Comparing the Efficacy of Nab-PH+Pyrrolitinib and TCbHP in the Neoadjuvant Treatment of HER2 Positive BC
At present, the incidence rate of breast cancer has exceeded that of lung cancer, becoming the largest cancer in the world. HER2 overexpression breast cancer accounts for about 20%~30% of all breast cancer patients.
- Trial name
- NCT05918328
- Testing
- Albumin paclitaxel+trastuzumab+pyrrolitinib, Docetaxel+Carboplatin+trastuzumab+Parstuzumab
- Where
- China
- Volunteers
- 610 people
- Sponsor
- Henan Cancer Hospital
Breast Cancer
A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Ribociclib + AI/FUL, or With Endocrine Therapy or Chemotherapy as First Line Treatment
This is a non-interventional observational study conducted in Germany to evaluate the real-world effectiveness, tolerability, safety, and quality of life in patients with locally advanced/metastatic HR+/HER2- breast cancer…
- Trial name
- RIBANNA (NCT06311383)
- Testing
- First-line Ribociclib + endocrine therapy, First-line endocrine therapy, First-line chemtherapy
- Where
- 265 sites in Germany
- Volunteers
- 2,610 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
A Comparing Study Between ALT02(Trastuzumab Biosimilar) and Herceptin® in Healthy Subjects
The purpose of this study is to compare ALT02 (Trastuzumab biosimilar) and Herceptin® (US-licensed Trastuzumab and EU-licensed Trastuzumab) in healthy male subjects about the pharmacokinetics, safety, tolerability and…
- Trial name
- NCT03242239
- Testing
- ALT02, EU-licensed Herceptin, US-licensed Herceptin
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Alteogen, Inc.
Breast Neoplasm Female
A Prospective, Open, Multicenter Single-arm Clinical Studie of Docetaxel, Carboplatin Combined With Inetetamab and Pyrotinib in the Treatment of Local-advanced HER2-positive Breast Cancer
This study is a prospective, open, multi-center, single arm trial. The treatment group will receive six cycles of docetaxel, carboplatin combined with Inetetamab and Pyrotinib before surgery.
- Trial name
- neoPICD (NCT06234137)
- Testing
- Docetaxel, Carboplatin, Inetetamab
- Where
- China
- Volunteers
- 154 people
- Sponsor
- Wang Ouchen
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.
Breast Cancer
SHR-A1811 and THPy in First or Second Line for HER2 Positive Advanced Breast Cancer Brain Metastases
The aim of this project is to evaluate whether the sequence of Trastuzumab，pyrotinib and Nab-Paclitaxel in first line followed by SHR-A1811 in second line is superior to the sequence of SHR-A1811 in first line followed by…
- Trial name
- NCT06975475
- Testing
- SHR-A1811,tratuzumab,pyrotinib,Nab-Paclitaxel
- Volunteers
- 60 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locally Advanced Breast Cancer, Metastatic Breast Cancer
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated…
- Trial name
- reaINAVO (NCT07347600)
- Testing
- Inavolisib, Palbociclib, Fulvestrant
- Where
- 32 sites in China
- Volunteers
- 500 people
- Sponsor
- Hoffmann-La Roche
Triple Negative Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast
Comparison of the Breast Tumor Microenvironment
The goal of the project is to identify a molecular signature of tumor stroma from "normal" adjacent breast tissue obtained prospectively at the time of breast conserving surgery before and after receiving intraoperative radiation…
- Trial name
- NCT03165487
- Testing
- Breast tissue collection, Blood sample collection
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Columbia University
HER2 Positive Metastatic Breast Cancer
A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of…
- Trial name
- NCT02422199
- Testing
- pyrotinib, Lapatinib, capecitabine
- Where
- 2 sites in China
- Volunteers
- 128 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Carcinoma in Situ
Trastuzumab Plus Taxane Neoadjuvant Therapy for HER2-Positive Breast Ductal Carcinoma In Situ (DCIS) : A Phase II Study
This is a phase II single-center single-arm clinical study designed to analyze the efficacy and safety of trastuzumab combined with taxane neoadjuvant therapy for HER2-positive breast carcinoma in situ (or with invasive…
- Trial name
- NCT06843681
- Testing
- Trastuzumab combined with taxane neoadjuvant therapy
- Where
- China
- Volunteers
- 54 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer, Breast Cancer - Female
TEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer
The purpose of this study is to find out if the investigational drug Ribociclib (LEE011), when taken with standard treatment (Tamoxifen +/- Goserelin) is safe and has beneficial effects in pre-menopausal and post-menopausal women…
- Conditions
- Breast Cancer, Breast Cancer - Female, Breast Cancer - Male
- Trial name
- NCT02586675
- Testing
- Tamoxifen, Ribociclib, Goserelin
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
HER-2 Positive Advanced Solid Tumors
A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors
This first-in-human (FIH) study, multi-center, open-label, dose escalation and dose expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary…
- Trial name
- NCT05957536
- Testing
- D3L-001
- Where
- 9 sites in United States, Australia and 1 more
- Volunteers
- 128 people
- Sponsor
- D3 Bio (Wuxi) Co., Ltd
Breast Neoplasms
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic.
- Trial name
- NCT07060807
- Testing
- Patritumab deruxtecan, Paclitaxel, Nab-paclitaxel
- Where
- 206 sites in United States, Argentina and 24 more
- Volunteers
- 1,000 people
- Sponsor
- Merck Sharp & Dohme LLC
Breast Cancer
Study of AC699 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer
This clinical trial is evaluating a drug called AC699 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer.
- Trial name
- NCT05654532
- Testing
- AC699
- Where
- 9 sites in United States
- Volunteers
- 100 people
- Sponsor
- Accutar Biotechnology Inc
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