Clinical trials: HER2-positive Breast Cancer
Metastatic Breast Cancer
A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)
This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or…
- Trial name
- KATE3 (NCT04740918)
- Testing
- Trastuzumab Emtansine, Atezolizumab
- Where
- 51 sites in United States, Australia and 17 more
- Volunteers
- 96 people
- Sponsor
- Hoffmann-La Roche
HER2 Positive Breast Carcinoma
AI-based pCR Assessment/Prediction in HER2-Positive BC Using PET/MRI
Goal of the observational study: Based on PET/MRI data it is possible to differentiate between complete and incomplete pathological remission after neoadjuvant systemic therapy in HER2-positive breast cancer patients.
- Trial name
- NCT06708910
- Where
- Germany
- Volunteers
- 460 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
HER2-positive Breast Cancer
Tucatinib in Patients With Locally Advanced or Metastatic HER2-positive Breast Cancer Who Received at Least Two Prior Anti-HER2 Treatment Regimens.
The objective of this non-interventional study (NIS) is to evaluate tucatinib (TUKYSA®) combined with trastuzumab and capecitabine in adult patients with locally advanced or metastatic HER2-positive breast cancer who have been…
- Trial name
- TRACE (NCT05253911)
- Testing
- TUKYSA®
- Where
- 2 sites in Austria, Germany
- Volunteers
- 49 people
- Sponsor
- iOMEDICO AG
Breast Cancer Stage IV
Inetetamab Combined With Paclitaxel With/Without Pertuzumab for Previously Treated HER2-positive Advanced Breast Cancer
This study is designed to comprehensively evaluate the HER2 positive recurrent/metastatic breast cancer patients in the real world who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab, including basic…
- Trial name
- NCT06578299
- Testing
- Inetetamab and Paclitaxel ± Pertuzumab
- Volunteers
- 100 people
- Sponsor
- Fudan University
Breast Cancer, Invasive Breast Cancer
Window of Opportunity Trial of Entinostat in Patients With Newly Diagnosed Stage I-IIIC,TNBC
This study is investigational and is not designed to treat cancer. In other words, the study drug, entinostat, is not being given to treat cancer.
- Conditions
- Breast Cancer, Invasive Breast Cancer, ER-Negative PR-Negative HER2-Negative Breast Cancer
- Trial name
- NCT03361800
- Testing
- Entinostat
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Metastatic Breast Cancer, HER2+ Breast Cancer
Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer
This study will assess the safety and efficacy of BKM120 in combination with trastuzumab in patients with relapsing HER2 overexpressing breast cancer who have previously failed trastuzumab.
- Trial name
- NCT01132664
- Testing
- BKM120, Trastuzumab, Capecitabine
- Where
- 21 sites in United States, Belgium and 4 more
- Volunteers
- 72 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Molecular Analyses to Predict Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer
This is an exploratory phase II interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for 4-12 weeks (+/- 2 weeks).
- Trial name
- MAPPER (NCT06361940)
- Testing
- Aromatase inhibitors or tamoxifen
- Where
- United States
- Volunteers
- 185 people
- Sponsor
- Medical College of Wisconsin
Melanoma (Skin Cancer), HER2-low Hormone Receptor Positive Breast Cancer
Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors
This study will evaluate the safety, tolerability, and preliminary effectiveness of AMXT 1501 and DFMO when combined with standard treatments for advanced solid tumors.
- Trial name
- NCT07287917
- Testing
- AMXT 1501 Dicaprate, DFMO, Fulvestrant
- Where
- 20 sites in United States
- Volunteers
- 92 people
- Sponsor
- Aminex Therapeutics, Inc.
HER2 Positive Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7
Neratinib in Treating Older Patients With Stage IV HER2-Positive Breast Cancer
This phase II trial studies the side effects of and how well neratinib works in treating older patients with stage IV HER2-positive breast cancer.
- Trial name
- NCT02673398
- Testing
- Comprehensive Geriatric Assessment, Laboratory Biomarker Analysis, Neratinib
- Where
- 7 sites in United States
- Volunteers
- 25 people
- Sponsor
- City of Hope Medical Center
Breast Neoplasms, Lung Neoplasms
Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM
TROPION-DM/BrUOG-431 is a prospective, , phase 2 trial with two non-comparative cohorts analyzed jointly for primary endpoint in adult patients with either (Cohort 1:) advanced/metastatic hormone-receptor positive ([HR+]…
- Trial name
- NCT06974604
- Testing
- Dexamethasone oral
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Brown University
HR+ HER2- Breast Cancer
Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants…
- Trial name
- NCT07558733
- Testing
- Serabelisib, Sapanisertib, Fulvestrant
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- Faeth Therapeutics
Triple Negative Breast Cancer, HER2-positive Breast Cancer
Exosome as the Prognostic and Predictive Biomarker in EBC Patients
This study is the experimental study for serial ctDNA and exosome evaluation in EBC patients
- Trial name
- NCT05955521
- Testing
- exosome and ctDNA evaluation
- Where
- South Korea
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Samsung Medical Center
Breast Cancer
Trastuzumab With or Without Everolimus in Treating Women With Breast Cancer That Can Be Removed By Surgery
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread.
- Trial name
- NCT00674414
- Testing
- trastuzumab, everolimus, therapeutic conventional surgery
- Where
- 8 sites in France
- Volunteers
- 82 people
- Sponsor
- UNICANCER
Breast Cancer, HR Positive/HER2 Low Breast Cancer
Neoadjuvant Dalpiciclib + AI → SHR-A1811 for HR+/HER2-Low Breast Cancer
This is a phase II, single-arm, prospective exploratory study to evaluate the efficacy and safety of neoadjuvant dalpiciclib (a CDK4/6 inhibitor) plus an aromatase inhibitor (AI) followed by SHR-A1811 (an anti-HER2 antibody-drug…
- Trial name
- TD-DASHER-01 (NCT07618923)
- Testing
- Dalpiciclib 125mg, Aromatase Inhibitor, SHR-A1811
- Volunteers
- 20 people
- Sponsor
- Tang-Du Hospital
HER2-positive Breast Cancer
Adjuvant Therapy Choice for Non-pCR HER2 Positive Early Breast Cancer After Neoadjuvant Therapy
Chemotherapy combined with trastuzumab and patuzumab is the standard neoadjuvant therapy for HER2 positive breast cancer patients.
- Trial name
- nonPHER (NCT06693037)
- Where
- China
- Volunteers
- 2,092 people
- Sponsor
- Shu Wang
Breast Cancer
18F-fluoroestradiol (18F-FES) PET/CT Guided First-line Treatment for HR+/HER2- Metastatic Breast Cancer Patients
A single-center, real world study to evaluate the role of FES-PET in guiding the first-line treatment of HR+/HER2- MBC patients.
- Trial name
- NCT06655545
- Where
- China
- Volunteers
- 473 people
- Sponsor
- Fudan University
HER2-positive Breast Cancer
A Randomized Controlled Trial of HER-2 Positive Breast Cancer Patients Treated With Lapatinib vs Herceptin
This is a randomized controlled trial of HER-2 positive breast cancer patients treated with lapatinib and paclitaxel vs herceptin and paclitaxel with sequential and synchronous anthracycline
- Trial name
- NCT03085368
- Testing
- lapatinib/herceptin
- Where
- China
- Volunteers
- 482 people
- Sponsor
- Peking Union Medical College Hospital
Breast Cancer
12 weekS Adjuvant dOcetaxel Plus trastuzumaB in Patients With Small, Node-negative, HER2-positive Breast cancER (SOBER)
This phase II trial aims to study the efficacy and safety of 12 weeks adjuvant docetaxel plus trastuzumab in patients with tumors ≤1cm, node-negative, HER2-positive breast cancer.
- Trial name
- SOBER (NCT03367676)
- Testing
- Trastuzumab, Docetaxel
- Where
- China
- Volunteers
- 78 people
- Sponsor
- Ruijin Hospital
Breast Cancer
A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer
This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal…
- Trial name
- NCT00022672
- Testing
- trastuzumab (Herceptin®), anastrazole (Arimidex®)
- Where
- 132 sites in United States, Australia and 24 more
- Volunteers
- 208 people
- Sponsor
- Hoffmann-La Roche
Breast Neoplasms, Breast Diseases
A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases
This is a randomized, open, parallel-controlled, multicenter, phase II/III, seamless design clinical trial to compare the efficacy and safety of RC48-ADC with capecitabine + lapatinib in locally advanced or metastatic human…
- Conditions
- Breast Neoplasms, Breast Diseases, Capecitabine, HER2-positive Breast Cancer
- Trial name
- NCT03500380
- Testing
- RC48-ADC, Lapatinib, Capecitabine
- Where
- 67 sites in China
- Volunteers
- 301 people
- Sponsor
- RemeGen Co., Ltd.
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