Clinical trials: HER2 Low
Locally Advanced or Unresectable Metastatic Breast Cancer, Stage IV Breast Cancer
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available…
- Trial name
- ASCENT-07 (NCT05840211)
- Testing
- Sacituzumab Govitecan-hziy, Paclitaxel, Nab-paclitaxel
- Where
- 288 sites in United States, Argentina and 26 more
- Volunteers
- 654 people
- Sponsor
- Gilead Sciences
Triple Negative Breast Cancer, HER2-negative Breast Cancer
DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer
The purpose of the study is to find out if an investigational vaccine called Dendritic Cell (DC) vaccine given together with standard of care chemotherapy drugs can help people with Triple Negative and HR low positive breast…
- Trial name
- DecipHER (NCT05504707)
- Testing
- HER2 - primed Dendritic cells, HER3 - primed Dendritic cells
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
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.
Locally Advanced Unresectable Breast Carcinoma, Metastatic Breast Carcinoma
Cyclophosphamide and Veliparib in Treating Patients With Locally Advanced or Metastatic Breast Cancer
This phase I trial studies the side effects and best dose of cyclophosphamide and veliparib when given together in treating patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes or to…
- Conditions
- Locally Advanced Unresectable Breast Carcinoma, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma, Stage IIIB Breast Cancer AJCC v7
- Trial name
- NCT01351909
- Testing
- Cyclophosphamide, Laboratory Biomarker Analysis, Veliparib
- Where
- 5 sites in United States
- Volunteers
- 35 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer Metastatic
HER2-PET Imaging in HER2-low Breast Cancers
A strategy to target the oncogenic receptor HER2 using a version of the anti-HER2 therapeutic antibody trastuzumab coupled to desferrioxamine (DFO) and radiolabeled with zirconium-89 ([89Zr]-DFO-trastuzumab) has been successfully…
- Trial name
- NCT06732336
- Testing
- 89Zr-trastuzumab
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
HER2 Overexpression, Advanced Stage Breast Cancer
A Real-world Clinical Study of T-DXd for the Treatment of Chinese Patients With HER2 Overexpressing and HER2 Underexpressing Advanced Breast Cancer
The study is an open, prospective study to collect data on the efficacy and safety of T-DXd (DS8201) in Chinese patients with HER2 overexpressing and HER2 underexpressing advanced breast cancer in actual clinical practice in…
- Conditions
- HER2 Overexpression, Advanced Stage Breast Cancer, Low Expression of HER2
- Trial name
- NCT07035353
- Testing
- T-DXd (DS8201) 5.4 mg/kg, IVD, 1 cycle every 21 days.
- Volunteers
- 200 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Locally Advanced or Metastatic Breast Cancers
Study Aiming to Compare the Plasma Exposure of the Payload (Free-DXd) in Patients Treated by T-DXd for Locally Advanced or Metastatic Breast Cancer According to Their BMI.
This is a multicenter, prospective, non-randomized, open-label, pharmacokinetic study, aiming to compare the plasma exposure of the payload (free-DXd) in patients treated by T-DXd for locally advanced or metastatic breast cancer…
- Trial name
- TDXdose (NCT07195344)
- Testing
- Pharmacokinetics blood samples
- Where
- 10 sites in France
- Volunteers
- 210 people
- Sponsor
- Institut Claudius Regaud
Metastatic Breast Cancer
A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer
DESTINY-Breast 08 will investigate the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies in patients with Metastatic HER2-low Advanced or Metastatic Breast Cancer
- Trial name
- DB-08 (NCT04556773)
- Testing
- Trastuzumab deruxtecan, Durvalumab, Paclitaxel
- Where
- 37 sites in United States, Australia and 8 more
- Volunteers
- 138 people
- Sponsor
- AstraZeneca
Breast Cancer
Research on AI Models for Predicting Breast Cancer Treatment Effectiveness to Guide Her-2 Targeted ADC Therapy
This study aims to develop an AI-based predictive tool to help clinicians more accurately determine whether breast cancer patients can benefit from HER-2-targeted antibody-drug conjugate (T-DXd) therapy before treatment.
- Trial name
- NCT07689929
- Where
- China
- Volunteers
- 900 people
- Sponsor
- Zhejiang Cancer Hospital
Breast Cancer
UNFOLD Study Egypt
Breast cancer is a major public health concern worldwide. In Egypt, it was the most diagnosed cancer among females in 2020 with an incidence rate of 32.4%.
- Trial name
- NCT06188494
- Where
- 7 sites in Egypt
- Volunteers
- 405 people
- Sponsor
- AstraZeneca
Breast Cancer
Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer
Evaluating the Efficacy of Disitamab Vedotin in Combination with RC148 Compared to Albumin-bound Paclitaxone Monotherapy or in Combination with Toripalimab for Subjects with HR-negative, HER2-low Expressing Unresectable Locally…
- Trial name
- NCT06642545
- Testing
- Disitamab Vedotin, RC148, Albumin-bound Paclitaxone
- Where
- China
- Volunteers
- 40 people
- Sponsor
- RemeGen Co., Ltd.
HR Positive/HER2 Low Breast Cancer
SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer
This is an open-label, phase II study evaluating the efficacy and safety of SHR-A1811 alone or in combination with Adebrelimab in Stage II-III HR Positive/HER2 Low Breast Cancer.
- Trial name
- NCT06340230
- Testing
- SHR-A1811 Injection + Adebrelimab Injection, SHR-A1811 Injection
- Where
- China
- Volunteers
- 93 people
- Sponsor
- Shengjing Hospital
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Trastuzumab Deruxtecan Plus Nivolumab Plus Capecitabine Plus Oxaliplatin for HER2 Low Gastric and Gastroesophageal Junction Adenocarcinoma
To evaluate the safety and tolerability of the combination therapy of T-DXd, nivolumab, and chemotherapy in patients with untreated HER2-low gastric or gastroesophageal junction adenocarcinoma, and to determine the recommended…
- Trial name
- T-DXd_HER2Low (NCT07529613)
- Testing
- T-DXd, Nivolumab, Capecitabine
- Where
- Japan
- Volunteers
- 30 people
- Sponsor
- National Cancer Center Hospital East
Hormone Receptor(HR)-Positive, Low HER2 Advanced Breast Cancer Patients (HER2 IHC 1+ or 2+ & ISH Negative)
Trastuzumab Deruxtecan vs Endocrine Therapy in Low-HER2 HR+ Advanced Breast Cancer
"This is a randomized phase II, two-arm, open label, clinical trial to identify LP-WGS ctDNA biomarker to predict T-DXd response in low-HER2 expressing advanced breast cancer patients compared with endocrine therapy.
- Trial name
- NCT06837792
- Testing
- Experimental treatment arm, Control treatment arm
- Where
- South Korea
- Volunteers
- 141 people
- Sponsor
- Yonsei University
Breast Cancer
Real-world Study of Trastuzumab Deruxtecan in Patients With Unresectable or Metastatic HER2-low Breast Cancer
A longitudinal, non-interventional study with trastuzumab deruxtecan for patients with HER2-low expressing unresectable or metastatic breast cancer in Bulgaria and Slovenia
- Trial name
- EXPLORE (NCT06727227)
- Testing
- trastuzumab deruxtecan
- Where
- 14 sites in Bulgaria, Slovenia
- Volunteers
- 138 people
- Sponsor
- AstraZeneca
Metastatic Breast Cancer
Low -Dose-bevacizumab and Pemetrexed Versus TPC in Metastatic HER2-negative Breast Cancer Patients
This is a single-center, open, randomized, controlled phase 2 clinical trial designed to compare low-dose-bevacizumab and pemetrexed with TPC in metastatic HER2-negative breast cancer patients after failure of taxanes and…
- Trial name
- NCT02829008
- Testing
- low-dose-bevacizumab/pemetrexed, Treatment of physician's choice
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Chinese Academy of Medical Sciences
Breast Cancer
Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before.
- Trial name
- NCT03734029
- Testing
- Trastuzumab deruxtecan (DS-8201a), Capecitabine, Eribulin
- Where
- 208 sites in United States, Austria and 18 more
- Volunteers
- 557 people
- Sponsor
- Daiichi Sankyo
Biliary Tract Neoplasms Immunotherapy
Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib as First-Line Therapy for Advanced HER2-Positive/HER2-Low Biliary Tract Cancer
This phase II study evaluates the efficacy and safety of Trastuzumab Rezetecan in combination with Adebrelimab and Lenvatinib as first-line therapy for patients with locally advanced or metastatic HER2-positive or HER2-low…
- Trial name
- NCT07670273
- Testing
- Trastuzumab Rezetecan, Adebrelimab, Lenvatinib
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Peking Union Medical College Hospital
Breast Neoplasms
A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)
The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC)…
- Trial name
- NCT06926868
- Testing
- Iza-bren, Nab-paclitaxel, Paclitaxel
- Where
- 295 sites in United States, Argentina and 26 more
- Volunteers
- 600 people
- Sponsor
- Bristol-Myers Squibb
HER2-positive Breast Cancer, Metastatic Cancer
PRE-ISPY Phase I/II Oncology Platform Program
PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced…
- Conditions
- HER2-positive Breast Cancer, Metastatic Cancer, Metastatic Breast Cancer, Metastatic
- Trial name
- PRE-ISPY (NCT05868226)
- Testing
- ALX148, Fam-Trastuzumab Deruxtecan-Nxki, Zanidatamab
- Where
- 10 sites in United States
- Volunteers
- 280 people
- Sponsor
- QuantumLeap Healthcare Collaborative