Clinical trials: HER2/Neu Positive
Breast Cancer
Phase I/II Study of Neoadjuvant Lapatinib in Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00450892
- Testing
- docetaxel+lapatinib, docetaxel + trastuzumab, docetaxel + trastuzumab + lapatinib
- Where
- 15 sites in Belgium, France and 3 more
- Volunteers
- 129 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Early Breast Cancer, Metastatic Breast Cancer
Real-World Data of Clinicopathological Characteristics and Management of Breast Cancer Patients According to HER2 Status
This is a data-driven, retrospective, longitudinal, population- based, observational, multi-centered study using secondary data captured from congruent electronic health records (EHRs).
- Conditions
- Early Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
- Trial name
- RosHER (NCT05217381)
- Where
- 7 sites in Spain
- Volunteers
- 18,533 people
- Sponsor
- MedSIR
Breast Cancer Metastatic
MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer.
A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2.
- Trial name
- NCT03321981
- Testing
- Zenocutuzumab, Trastuzumab, Vinorelbine
- Where
- 25 sites in United States, Belgium and 5 more
- Volunteers
- 105 people
- Sponsor
- Merus B.V.
Breast Cancer, Chemotherapeutic Toxicity
AC vs TC in Patients With HR-positive, HER2-negative Early Breast Cancer
Anthracycline-paclitaxel sequential combination therapy is the standard regimen for perioperative chemotherapy in breast cancer. The strategy of perioperative chemotherapy is based on breast cancer subtype, i.e.
- Trial name
- NCT05302336
- Testing
- Liposomal doxorubicin + Cyclophosphamide vs Docetaxel + Cyclophosphamide
- Where
- China
- Volunteers
- 402 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
HER2-positive Breast Cancer
Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer
The purpose of this study is to test the safety of Adoptive T-Cell therapy following the Dendritic Cell (DC1) study vaccine given in combination with pepinemab added to standard of care therapy, trastuzumab to help people with…
- Trial name
- NCT05378464
- Testing
- Dendritic Cell (DC1) Vaccine, Trastuzumab, Pepinemab
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Advanced/Metastatic HER2-negative Breast Cancer
Real-World Outcomes of Patients With Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6i
This study aims to assess the treatment patterns and real-world outcomes of HR+/HER- metastatic breast cancer patients who have progressed on 1L ET + CDK4/6i and started a second line (2L) treatment within a real-world cohort in…
- Trial name
- NCT06975371
- Testing
- No drug
- Where
- United States
- Volunteers
- 1,415 people
- Sponsor
- Daiichi Sankyo
Solid Tumors, Breast Cancer
Clinical Trial of the Combination of Trastuzumab (Herceptin) and Tanespimycin in Patients With Solid Tumors and Her2 Positive Metastatic Breast Cancer That Have Previously Failed Herceptin
The primary purpose(s) of this study is to determine the highest tolerated dose of tanespimycin and to determine anti-tumor activity (via objective response rate) of tanespimycin in patients with breast cancer who have not…
- Trial name
- NCT00773344
- Testing
- Tanespimycin
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Bristol-Myers Squibb
Muscle-Invasive Bladder Cancer (MIBC)
Trastuzumab Rezetecan and Adebrelimab as Neoadjuvant Therapy for HER2-Positive Muscle-Invasive Bladder Cancer
This study aims to evaluate the efficacy and safety of neoadjuvant trastuzumab rezetecan combined with adebrelimab for the treatment of HER2-positive muscle-invasive bladder cancer.
- Trial name
- NCT07624201
- Testing
- Trastuzumab Rezetecan Combined with Adebelizumab
- Where
- China
- Volunteers
- 58 people
- Sponsor
- Harbin Medical University
Cancer
Observational Study on the Treatment of Patients With Metastatic Breast Cancer
This is a descriptive, retrospective, observational study to generate Real-World Evidence (RWE). This study will evaluate the treatment patterns and outcomes with metastatic or unresectable hormone receptor-positive breast cancer…
- Trial name
- REALNESS (NCT06676436)
- Where
- 4 sites in Brazil
- Volunteers
- 204 people
- Sponsor
- AstraZeneca
Breast Cancer
BETH Study: Treatment of HER2 Positive Breast Cancer With Chemotherapy Plus Trastuzumab vs Chemotherapy Plus Trastuzumab Plus Bevacizumab
The trial will determine the value of adding bevacizumab to chemotherapy plus trastuzumab in patients with resected node-positive or high risk node-negative, HER2-positive breast cancer.
- Trial name
- BETH (NCT00625898)
- Testing
- Docetaxel, Trastuzumab, Carboplatin
- Where
- 649 sites in United States, Argentina and 38 more
- Volunteers
- 3,509 people
- Sponsor
- NSABP Foundation Inc
Early and Locally Advanced Breast Cancer
ABCSG 61 / TEODOR : Neoadjuvant TrEatment Optimization Driven by Circulating Tumor DNA and endOcrine Responsiveness
The goal of this performance study is to learn if treatment with neoadjuvant endocrine therapy compared to chemotherapy has comparable efficacy, but better quality of life outcomes in endocrine responsive participants with early…
- Trial name
- TEODOR (NCT07084558)
- Testing
- blood sample for Signatera (TM) test, biopsy for Ki-67 assessment, FFPE tumor sample for Signatera (TM) test (archived)
- Where
- 14 sites in Austria
- Volunteers
- 350 people
- Sponsor
- Austrian Breast & Colorectal Cancer Study Group
Estrogen Receptor Positive, HER2/Neu Negative
Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer
This phase I/II trial studies side effects and best dose of copanlisib when given together with letrozole and palbociclib and to see how well they work in treating hormone receptor positive HER2 negative stage I-IV breast cancer.
- Conditions
- Estrogen Receptor Positive, HER2/Neu Negative, Invasive Breast Carcinoma, Multifocal Breast Carcinoma
- Trial name
- NCT03128619
- Testing
- Biopsy of Breast, Copanlisib, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Jonsson Comprehensive Cancer Center
HER2 Positive Advanced/Metastatic/Nonresectable Biliary Tract Cancer
First-line Trastuzumab, Gemcitabine, Cisplatin and Nivolumab in Advanced HER2- Positive Biliary Tract Cancer: a Multicenter, Open-label, Single-arm Phase Ib/II Trial (HERBOT)
Biliary tract cancer is a rare malignant neoplasm including intrahepatic cholangiocarcinoma (IhCCA), extrahepatic cholangiocarcinoma (EhCCA) and Gallbladder cancer (GBC).
- Trial name
- NCT05749900
- Testing
- Trastuzumab+Nivolumab+Gemcitabine+Cisplatin
- Where
- South Korea
- Volunteers
- 44 people
- Sponsor
- Yonsei University
Metastatic Breast Cancer
A Study of Trastuzumab-Mcc-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer
Study of trastuzumab emtansine (T-DM1) administered to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.
- Trial name
- NCT00679211
- Testing
- Trastuzumab emtansine [Kadcyla]
- Volunteers
- 110 people
- Sponsor
- Genentech, Inc.
HER2-positive Recurrent/Metastatic Breast Cancer
A Study to Evaluate Inetetamab + Pyrotinib + Chemotherapy in Previously Untreated HER2-Positive Metastatic Breast Cancer
Studies H0648g and M77001 confirmed that the combination of trastuzumab with taxanes significantly improved TTP and OS, establishing the status of trastuzumab combined with taxanes as first-line standard therapy.The CLEOPATRA and…
- Trial name
- NCT05621434
- Testing
- Inetetamab, pyrotinib, chemotherapy
- Volunteers
- 63 people
- Sponsor
- Fujian Medical University
Breast Neoplasm, Brain Metastases
MRI Screening Versus SYMptom-directed Surveillance for Brain Metastases Among Patients with Triple Negative or HER2+ MBC
In this study, 50 women with either HER2+ or triple negative metastatic breast cancer but no known brain metastases will be recruited at the Sunnybrook Odette Cancer Centre.
- Conditions
- Breast Neoplasm, Brain Metastases, Triple Negative Breast Cancer, HER2-positive Breast Cancer
- Trial name
- SYMPToM (NCT03881605)
- Testing
- MRI screening
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Sunnybrook Health Sciences Centre
Metastatic Breast Cancer
Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)
The purpose of this study is to assess the efficacy and safety of belzutifan (MK-6482) plus fulvestrant compared to everolimus plus endocrine therapy (ET) (investigator's choice of fulvestrant or exemestane) in adults with…
- Trial name
- NCT06428396
- Testing
- Belzutifan, Fulvestrant, Everolimus
- Where
- 41 sites in United States, Argentina and 7 more
- Volunteers
- 120 people
- Sponsor
- Merck Sharp & Dohme LLC
Colorectal Neoplasms
Disitamab Vedotin Combined With Tislelizumab in Advanced HER2 Positive Colorectal Cancer
Among patients with colonrectal cancer, 5% were HER-2 positive, but the immunohistochemical results were mostly HER-2 2 +, which did not meet the indications of HER-2 targeting drugs.
- Trial name
- NCT05493683
- Testing
- Disitamab vedotin, Tislelizumab
- Where
- 6 sites in China
- Volunteers
- 29 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Metastatic Breast Cancer, Stage IV Breast Cancer
A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer
The purpose of this study is to test different doses of abemaciclib to find the best dose in participants while receiving hormone therapy and radiation therapy.
- Conditions
- Metastatic Breast Cancer, Stage IV Breast Cancer, Breast Cancer, Breast Cancer Stage IV
- Trial name
- NCT06678269
- Testing
- Abemaciclib, Radiation Therapy
- Where
- 7 sites in United States
- Volunteers
- 28 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer, Chemotherapy Effect
Efficacy of Supplement Adjuvant Capecitabine in HR+/HER2- Breast Cancer Patients With High Risks
According to the latest data from the World Health Organization's International Agency for Research on Cancer (IARC) for 2020, breast cancer has been the most prevalent cancer with 2.26 million new cases.
- Trial name
- NCT05212454
- Testing
- Capecitabine
- Where
- China
- Volunteers
- 400 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine