Clinical trials: HER2-positive Breast Cancer
HER2 Positive Solid Tumors
A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors
A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies
- Trial name
- NCT04460456
- Testing
- SBT6050, pembrolizumab, Cemiplimab
- Where
- 12 sites in United States, Australia and 1 more
- Volunteers
- 58 people
- Sponsor
- Silverback Therapeutics
Breast Cancer
Safety, Tolerability, and Pharmacokinetic (PK) Study of DHES0815A in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Breast Cancer
This first-in-human, Phase 1, open-label, multicenter, dose-escalation study will evaluate the safety, tolerability, and PK of DHES0815A as a single agent in participants with advanced and/or metastatic HER2-positive breast…
- Trial name
- NCT03451162
- Testing
- DHES0815A
- Where
- 5 sites in United States, South Korea
- Volunteers
- 14 people
- Sponsor
- Genentech, Inc.
Breast Cancer Female
Impact of Recurrence Score on Adjuvant Treatment Decisions in Breast Cancer Patients
IRMA is a Prospective, monocenter, non-interventional investigator initiated (IIT) registry that aims to investigate the use of the CE-marked OncotypeDX and its impact on adjuvant therapy recommendations in the clinical routine.
- Trial name
- NCT03961880
- Where
- Germany
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- University Hospital Tuebingen
Breast Cancer
A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab) and Xeloda (Capecitabine) in Patients With HER2-Positive Breast Cancer
This single arm study will assess the efficacy and safety of Avastin in combination with Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent or metastatic breast cancer.
- Trial name
- NCT00811135
- Testing
- bevacizumab [Avastin], capecitabine [Xeloda], trastuzumab [Herceptin]
- Where
- 35 sites in Denmark, France and 4 more
- Volunteers
- 88 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Adjuvant Therapy
Compare Continuation of Original Targeted Therapy With Trastuzumab Combined With Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in Non-pCR Patients With HER2 Positive Early Breast Cancer
To evaluate the efficacy of continuation targeted therapy compared with trastuzumab combined with Pyrotinib and capecitabine in postoperative adjuvant therapy of HER-2 positive early breast cancer patients with residual tumor…
- Trial name
- NCT05292742
- Testing
- Pyrotinib+Trastuzumab+Capecitabine, Trastuzumab+Pertuzumab/Trastuzumab
- Where
- China
- Volunteers
- 206 people, healthy volunteers welcome
- Sponsor
- Fujian Medical University Union Hospital
Breast Cancer
A Study of the Addition of Metronomic Capecitabine to Standard Adjuvant Therapy in High Risk HER2+ BC paTients
Breast cancer is the most common malignant tumor in women. Recurrent or metastatic breast cancer is incurable. High risk patients usually have the following characteristics, such as, non-pCR after neoadjuvant therapy, lymph nodes…
- Trial name
- SMART (NCT03561740)
- Testing
- capecitabine
- Where
- China
- Volunteers
- 794 people
- Sponsor
- Sun Yat-sen University
Advanced Breast Carcinoma, Advanced Colon Carcinoma
Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial
The dose escalation phase of this trial identifies the safety, side effects and best dose of ceralasertib (AZD6738) when given in combination with trastuzumab deruxtecan (DS-8201a) in treating patients with solid tumors that have…
- Conditions
- Advanced Breast Carcinoma, Advanced Colon Carcinoma, Advanced Colorectal Carcinoma, Advanced Endometrial Carcinoma
- Trial name
- NCT04704661
- Testing
- Biopsy Procedure, Biospecimen Collection, Ceralasertib
- Where
- 23 sites in United States
- Volunteers
- 51 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
HER2 Expression of CTC to Predict Response in HER2-positive Advanced Breast Cancer Patients Treated With ADC
To evaluate the predictive and prognostic value of HER2 expression of circulating tumor cells in HER2-positive advanced breast cancer patients treated with ADC
- Trial name
- NCT05834686
- Testing
- HER2 expression of circulating tumor cells
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Beijing 302 Hospital
Breast Cancer
A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer
This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant…
- Trial name
- NCT01966471
- Testing
- Trastuzumab Emtansine, Trastuzumab, Pertuzumab
- Where
- 295 sites in United States, Australia and 34 more
- Volunteers
- 1,846 people
- Sponsor
- Hoffmann-La Roche
Hormone Receptor Positive Breast Cancer, Metastatic Breast Cancer
CDK4/6-inhibitor or Chemotherapy, in Combination with ENDOcrine Therapy, for Advanced Breast Cancer / KENDO
Prospective, open label, multicenter, group sequential response adaptive randomized phase 2 study, comparing two treatments for locally advanced or metastatic luminal breast cancer: Arm A: concomitant cyclin-dependent Kinase 4/6…
- Conditions
- Hormone Receptor Positive Breast Cancer, Metastatic Breast Cancer, Hormone Receptor Negative Breast Cancer
- Trial name
- KENDO (NCT03227328)
- Testing
- concomitant cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor plus endocrine therapy, chemotherapy plus endocrine therapy (administered either concomitantly or sequentially)
- Where
- 20 sites in Italy
- Volunteers
- 52 people
- Sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
HER2-positive Breast Cancer
Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab
The purpose of the study is to find out if an investigational drug called Dendritic Cell (DC1) vaccine added to standard neoadjuvant (given before main treatment) therapy can help people with HER2 (human epidermal growth factor…
- Trial name
- NCT05325632
- Testing
- HER-2 pulsed DC1, Trastuzumab, Pertuzumab
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Breast Cancer, Tumor, Breast
TRAIL-R2 and HER2 Bi-Specific Chimeric Antigen Receptor (CAR) T Cells for the Treatment of Metastatic Breast Cancer
The purpose of this study is to find the biggest dose of HTR2 T cells that is safe, to see how long these cells last in the body, to learn the side effects, and to see if these cells are able to fight and kill HER2 expressing…
- Conditions
- Breast Cancer, Tumor, Breast, Breast Tumor, Malignant Neoplasm of Breast
- Trial name
- NCT06251544
- Testing
- HTR2 T Cells
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Baylor College of Medicine
Triple Negative Breast Cancer, Early-stage Breast Cancer
Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast
An Open-Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Neratinib Followed by Weekly Paclitaxel and Carboplatin Plus Neratinib in Early Stage Triple-Negative Breast Cancer Patients Who Exhibit Enhanced…
- Conditions
- Triple Negative Breast Cancer, Early-stage Breast Cancer, HER2-positive Breast Cancer
- Trial name
- FACT-2 (NCT03812393)
- Testing
- Neratinib
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- West Cancer Center
Breast Cancer
Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer
The purpose of this study is to establish the dose regimen and evaluate the preliminary efficacy and the safety/tolerability of poziotinib in participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic…
- Trial name
- NCT02659514
- Testing
- Poziotinib
- Where
- 35 sites in United States
- Volunteers
- 67 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Breast Cancer
Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer
The purpose of this Phase III study was to confirm the value of adding everolimus to weekly paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.
- Trial name
- BOLERO-1 (NCT00876395)
- Testing
- Everolimus, Trastuzumab, Paclitaxel
- Where
- 140 sites in United States, Argentina and 26 more
- Volunteers
- 719 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer
This is a Phase 1b, open-label, multicenter study to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of poziotinib when administered with standard dosing of T-DM1 (3.6 mg/kg IV on Day 1 of each…
- Trial name
- NCT03429101
- Testing
- Poziotinib, T-DM1
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Breast Cancer
Study of Tumor and Blood Samples From Women With Breast Cancer
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
- Trial name
- NCT00897728
- Testing
- laboratory biomarker analysis
- Where
- France
- Volunteers
- 180 people
- Sponsor
- Institut Curie
Metastatic Breast Cancer, Breast Cancer Stage IV
BRaziLian outcomE for metAStatic breasT Cancer
Given the certain benefit in efficacy of adding CDK 4/6 inhibitor to first line endocrine therapy in metastatic breast cancer HR+ HER2- , the aim of this project is to evaluate whether patients without private health insurance…
- Trial name
- BREAST (NCT05559528)
- Where
- Brazil
- Volunteers
- 300 people
- Sponsor
- Hospital do Coracao
Breast Cancer, HER2-positive Breast Cancer
Trastuzumab Rezetecan (T-DXh) in HER2+ Breast Cancer With Non-pCR After TCbHP
This is a prospective, multi-center, single-arm, phase 2 exploratory study to evaluate the efficacy and safety of adding 4 cycles of Trastuzumab Rezetecan (T-DXh), an anti-HER2 antibody-drug conjugate, as continued neoadjuvant…
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Early-stage Breast Cancer, Locally Advanced Breast Cancer
- Trial name
- NCT07589699
- Testing
- Trastuzumab Rezetecan
- Volunteers
- 59 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Anatomic Stage IV Breast Cancer AJCC v8, HER2 Positive Breast Carcinoma
T-DM1 With or Without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer
This phase II trial studies how well T-DMI with or without abemaciclib works for the treatment of HER2-positive breast cancer that has spread to other places in the body (metastatic).
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, HER2 Positive Breast Carcinoma, Metastatic Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8
- Trial name
- NCT04351230
- Testing
- Abemaciclib, Trastuzumab Emtansine
- Where
- 6 sites in United States
- Sponsor
- Academic and Community Cancer Research United
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