Clinical trials: HER2-low Breast Cancer
Metastatic Breast Cancer
Sequencing SG vs. T-DXd in HER2-Low/TROP2-High Metastatic Breast Cancer
Currently, no phase III RCT has directly compared SG and T-DXd sequencing strategies, and the predictive role of biomarkers remains unclear. Additionally, there is no standard scoring system for Trop-2 expression.
- Trial name
- STORM (NCT07368543)
- Testing
- Sacituzumab Govitecan, Trastuzumab Deruxtecan
- Volunteers
- 216 people
- Sponsor
- Fudan University
HER2-negative Breast Cancer, Metastatic Breast Cancer
Predicting Olaparib Sensitivity in Patients With Unresectable Locally Advanced/Metastatic HER2-negative Breast Cancer.
The primary objetive is to assess the capacity of the RAD51-foci score to predict the efficacy of olaparib in BRCA1/2, PALB2 or RAD51C/D mut advanced breast cancer (cohort 1).
- Conditions
- HER2-negative Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer
- Trial name
- RADIOLA (NCT05340413)
- Testing
- Olaparib
- Where
- 5 sites in Spain
- Volunteers
- 65 people
- Sponsor
- SOLTI Breast Cancer Research Group
HER2-low Breast Cancer
A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer
This trial is a registered, phase III, randomized, open-label and multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable, locally recurrent or metastatic HER2-low breast cancer.
- Trial name
- NCT06957886
- Testing
- BL-M07D1, Capecitabine, Eribulin, Gemcitabine, Paclitaxel, or Albumin paclitaxel
- Where
- 2 sites in China
- Volunteers
- 566 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Metastatic Breast Cancer
A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)
The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+…
- Trial name
- NCT06018337
- Testing
- DB-1303/BNT323, Capecitabine, Paclitaxel
- Where
- 258 sites in United States, Argentina and 15 more
- Volunteers
- 541 people
- Sponsor
- DualityBio Inc.
Advanced or Metastatic Breast Cancer
A Study of MRG002 in the Treatment of Patients With HER2-low Locally Advanced or Metastatic Breast Cancer (BC)
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-low locally advanced or metastatic BC.
- Trial name
- NCT04742153
- Testing
- MRG002
- Where
- 2 sites in China
- Volunteers
- 66 people
- Sponsor
- Shanghai Miracogen Inc.
HR+/HER2- Advanced Breast Cancer
Albumin-bound Paclitaxel、Dalpiciclib and AI in ER-Low (1%-10%) HER2-ABC
This is a prospective, single-arm, single-center, open, exploratory clinical study.. Screening for histopathologically confirmed recurrent or metastatic ER-Low positive (1%-10%) and HER2-negative breast cancer patients who meet…
- Trial name
- NCT06711094
- Testing
- Dalpiciclib
- Volunteers
- 52 people
- Sponsor
- Fujian Medical University
Breast Cancer
SHR-A1811 in Combination With Adebrelimab for the Treatment of HER2 Low-expressing Metastatic Breast Cancer
To evaluate the efficacy and safety of the SHR-A1811 in combination with Adebrelimab regimen in HER2 low-expressing metastatic breast cancer
- Trial name
- NCT06411457
- Testing
- SHR-A1811+Adebrelimab
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Breast Neoplasms, Triple Negative Breast Neoplasms
A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
Researchers are looking for new ways to treat types of breast cancer that are both: High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment Early-stage, which means the cancer is…
- Conditions
- Breast Neoplasms, Triple Negative Breast Neoplasms, HR Low-Positive/HER2-Negative Breast Neoplasms
- Trial name
- NCT06966700
- Testing
- Sacituzumab tirumotecan, Pembrolizumab, Rescue Medication
- Where
- 331 sites in United States, Argentina and 39 more
- Volunteers
- 2,400 people
- Sponsor
- Merck Sharp & Dohme LLC
Breast Cancer
A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer
This trial is a randomized, open-label, multicenter Phase II study designed to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally recurrent or metastatic HR-positive, HER2-low expressing breast…
- Trial name
- NCT07678957
- Testing
- BL-M07D1, DS-8201
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Breast Cancer
Discontinuation of CDK4/6 Inhibitors in Patients With Metastatic HR Positive, HER2 Negative Breast Cancer
This is a low-intervention, randomized, non-comparative, open-label, multicenter, prospective, phase II trial investigating discontinuation of CDK4/6 inhibitors in patients with metastatic HR positive, HER2 negative breast cancer…
- Trial name
- NCT06207734
- Testing
- Continuation of CDK4/6 inhibitor Palbociclib, Discontinuation of CDK4/6 inhibitor Palbociclib, Continuation of CDK4/6 inhibitor -Palbociclib
- Where
- 13 sites in Germany
- Volunteers
- 120 people
- Sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Breast Cancer
Exploration of the Safety and Efficacy of T-DXd Concurrent With Brain Radiotherapy in Patients With Brain Metastases HER2-positive/HER2-low Advanced Breast Cancer
A study on the safety and efficacy of T-DXd in combination with local radiotherapy for brain metastases in HER2-Positive and HER2-Low breast cancer patients.
- Trial name
- NCT07117864
- Testing
- T-DXd concurrent brain radiotherapy
- Where
- China
- Volunteers
- 40 people
- Sponsor
- QIAO LI
Breast Cancer
Dalpiciclib Plus Fulvestrant With Pyrotinib in Hormone Receptor-positive, HER2-low Advanced Breast Cancer That Progressed on Previous CDK4/6i Plus AI Therapy
The purpose of this study is to determine if the triplet combination of dalpiciclib, fulvestrant, and pyrotinib is safe and effective in the treatment of hormone receptor-positive, HER2-low locally advanced/metastatic breast…
- Trial name
- NCT05806671
- Testing
- Dalpiciclib, Pyrotinib, Fulvestrant
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
PIK3CA Mutations, Advanced Solid Tumors, Adult
A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors
This is a Phase 1, two-part, open-label, nonrandomized, dose-escalation and signal-seeking study of CGT6297, evaluating the safety, tolerability, PK, pharmacodynamic (what the drug does to the body), and antitumor activity of…
- Conditions
- PIK3CA Mutations, Advanced Solid Tumors, Adult, Endometrial Cancer, HR Positive/HER-2 Negative Breast Cancer
- Trial name
- NCT07383506
- Testing
- CGT6297
- Where
- 12 sites in United States
- Volunteers
- 90 people
- Sponsor
- Cogent Biosciences, Inc.
HER2-Low Unresectable/Metastatic Breast Cancer Complicated With Visceral Crisis
The Efficacy and Safety of Trastuzumab Rezetecan (SHR-A1811) in HER2-Low Unresectable/Metastatic Breast Cancer Patients With Visceral Crisis
The goal of this clinical trial is to learn if Trastuzumab Rezetecan (SHR-A1811) is safe and tolerable for patients with HER2-Low unresectable/metastatic breast cancer complicated with visceral crisis.
- Trial name
- NCT07203729
- Testing
- Trastuzumab Rezetecan, Chemotherapy of Physician's Choice
- Where
- China
- Volunteers
- 184 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Advanced Breast Cancer
RC48-ADC in HER2-low Advanced Breast Cancer
To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) as salvage treatment in patients with HER2-low advanced breast cancer who have received up to one previous chemotherapy for recurrent or metastatic disease…
- Trial name
- NCT05831878
- Testing
- Disitamab vedotin
- Where
- China
- Volunteers
- 36 people
- Sponsor
- RenJi Hospital
Breast Cancer With Low Expression of HER2
ARX788 in Breast Cancer With Low Expression of HER2
A Phase 2 Study of ARX788 in unresectable and/or metastatic breast cancer with low expression of HER2.
- Trial name
- NCT05018676
- Testing
- ARX788
- Where
- China
- Volunteers
- 54 people
- Sponsor
- Fudan University
HER2-positive Early Breast Cancer
NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer
ADAPT-HER2-IV will address question of optimal neoadjuvant therapy in patients with less advanced -HER2+ EBC. ADAPT-HER2-IV is planned as a superiority trial to demonstrate higher pCR rates in both clinically relevant subgroups…
- Trial name
- ADAPTHER2-IV (NCT05704829)
- Testing
- Trastuzumab deruxtecan, Standard-of-Care
- Where
- 44 sites in Germany
- Volunteers
- 702 people
- Sponsor
- Women's Cancer Study Group GmbH
HER2 Low Advanced or Metastatic Breast Cancer
A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
This study aims to evaluate the safety, tolerability, PK and preliminary anti-tumour activity of SHR-A1811 combined with other therapies in patients with HER2 low advanced or metastatic breast cancer.
- Trial name
- NCT05792410
- Testing
- SHR-A1811 & Dalpiciclib Isethionate Tablets, SHR-A1811 & Fulvestrant, SHR-A1811 & Bevacizumab injection
- Volunteers
- 300 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer
An Observational Study of Patients Receiving T-DXd for Treatment of HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer
This study will collect real-world clinical and patient reported outcomes (PRO) and diary data from eligible patients with documented Human Epidermal Growth Factor Receptor 2 (HER2+) [globally] or HER2-low [North America only] in…
- Trial name
- DB RESPOND (NCT05592483)
- Testing
- None (Observational Study)
- Where
- 125 sites in United States, Austria and 7 more
- Volunteers
- 78 people
- Sponsor
- AstraZeneca
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