Clinical trials: HER2 Low
Breast Cancer Detection, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Validation of the Oncoliq Test for the Early Detection of Breast Cancer.
Cancer continues to be one of the most significant public health issues worldwide. Thanks to early detection, the mortality rate of certain types of cancer has decreased significantly.
- Conditions
- Breast Cancer Detection, Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Female, Breast Cancer - Ductal Carcinoma in Situ (DCIS)
- Trial name
- NCT07331506
- Testing
- Peripheral blood draw
- Where
- Argentina
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Oncoliq US Inc
HER2-positive Breast Cancer, HER2-low Breast Cancer
A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
This multi-center observational prospective study will collect real-world clinical and patient-reported outcome data from eligible patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior…
- Conditions
- HER2-positive Breast Cancer, HER2-low Breast Cancer, Breast Cancer, Advanced Cancer
- Trial name
- NCT06210776
- Testing
- Trastuzumab deruxtecan
- Where
- 54 sites in China
- Volunteers
- 800 people
- Sponsor
- Daiichi Sankyo
Patients With HER2-positive Advanced Breast Cancer Treated With T-DXd, Patients With HER2-low Advanced Breast Cancer Treated With T-DXd
NEPA in Patients With HER2-positive or HER2-low Advanced Breast Cancer Treated With T-DXd
This clinical trial is a prospective, observational, multicenter cohort study evaluating the efficacy and safety of NEPA (netupitant/palonosetron) in patients with HER2-positive or HER2-low advanced breast cancer treated with…
- Trial name
- PRO-NEPA (NCT07132749)
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Yeon Hee Park
Breast Cancer Early Stage Breast Cancer (Stage 1-3), HR Positive/HER2 Low Breast Cancer
Chemotherapy With or Without Adebrelimab and T-DXh as Neoadjuvant Therapy for HR+/HER2 Low Early Stage Breast Cancer
The goal of this clinical trial is to learn if add SHR-A1811 and/or Adebrelimab on standard chemotherapy could further improve the pCR rate in HR+/HER2 low early stage breast cancer patients.
- Trial name
- NCT07317778
- Testing
- SHR-A1811, Adebrelimab (PD-L1 inhibitor), Taxane Chemotherapy
- Where
- China
- Volunteers
- 249 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Breast Cancer Stage IV, HER2-low Breast Cancer
HER2-PET as a Precision Imaging Tool for Treatment With HER2-ADC in HER2-expressing mBC
This is a prospective, multi-center, open-label, exploratory diagnostic phase II imaging trial for patients with metastatic breast cancer with at least one line of systemic therapy.
- Conditions
- Breast Cancer Stage IV, HER2-low Breast Cancer, Molecular Imaging
- Trial name
- NCT06830382
- Testing
- Positron emission tomografy with [68Ga]Ga-ABY-025
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Renske Altena
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
HER2-low Hormone Receptor Positive Breast Cancer
A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients
This is a Phase II Study of HLX22 in Combination with Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression or Intolerable Adverse…
- Trial name
- NCT06832202
- Testing
- HLX22, Trastuzumab Deruxtecan
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Shanghai Henlius Biotech
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
Antibody-drug Conjugates, HER2-low Breast Cancer
Analysis of Exploring Optimized Sequential Treatment Strategies of Antibody-Drug Conjugates (ADCs) in HER2-Low-Expressing Breast Cancer
This study retrospectively analyzes the clinical data of HER2-low breast cancer (IHC 1+/2+ and FISH-negative) patients treated with sequential antibody-drug conjugates (ADCs).
- Conditions
- Antibody-drug Conjugates, HER2-low Breast Cancer, Breast Neoplasms
- Trial name
- NCT06877416
- Testing
- Non-intervention research
- Where
- China
- Volunteers
- 700 people
- Sponsor
- Sun Yat-sen University
Breast Adenocarcinoma, Breast Cancer Stage IV
Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study
PALMARES-2 is a retrospective/prospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+/HER2- aBC patients treated with first-line CDK4/6i plus ET.
- Conditions
- Breast Adenocarcinoma, Breast Cancer Stage IV, Breast Cancer, Metastatic, Breast Carcinoma
- Trial name
- PALMARES-2 (NCT06805812)
- Testing
- Palbociclib, Ribociclib, Abemaciclib
- Where
- 24 sites in Italy
- Volunteers
- 3,500 people
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Breast Cancer, Estrogen Receptor-Positive, HER2 Low Breast Cancer
A Study Evaluating the Efficacy and Safety of De Trastuzumab (T-DXd) in Combination with Immunotherapy for the Neoadjuvant Treatment of HR-positive HER2 Low-expressing Chinese Patients with Early-stage Breast Cancer
This is a prospective, open-label, multicenter, single-arm clinical study designed to compare the efficacy and safety of neoadjuvant treatment with T-DXd in combination with an immune checkpoint inhibitor in patients with primary…
- Trial name
- NCT06733233
- Testing
- T-DXd combined with immune checkpoint inhibitor
- Volunteers
- 23 people
- Sponsor
- Guangzhou Women and Children's Medical Center
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
HER2 Low Breast Carcinoma
A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer
HR-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk…
- Trial name
- NCT05911958
- Testing
- SHR-A1811 for injection
- Where
- China
- Volunteers
- 66 people
- Sponsor
- Henan Cancer Hospital
Advanced Breast Cancer, Treatment
Combination Followed by Maintenance Chemotherapy Versus CDK4/6 Inhibitor Combined With Endocrine Therapy for HR Low/HER2-negative Advanced Breast Cancer: a Prospective, Randomized, Open-label Phase Ⅱ Clinical Trial
To observe the differences in the efficacy of Combination followed by maintenance chemotherapy versus CDK4/6 inhibitor combined with endocrine therapy in HR low expression /HER2 negative advanced breast cancer, and to provide new…
- Conditions
- Advanced Breast Cancer, Treatment, HR Low/HER2 Negative
- Trial name
- NCT06176534
- Testing
- Experimental: chemotheyapy, Active Comparator: endocrine therapy
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Henan Cancer Hospital
Esophagus Cancer, Gastric Cancer
HER2 Status in Esophagogastric Adenocarcinoma and Its Associations With Patient's Clinicopathological Outcomes
Targeted therapies offer promise to improve oncologic outcomes in esophagogastric adenocarcinoma (EGA). The landmark 'Trastuzumab for gastric cancer (ToGA)' trial established the therapeutic value of Human Epidermal Growth Factor…
- Conditions
- Esophagus Cancer, Gastric Cancer, HER2-positive Cancer, HER2-low Cancer
- Trial name
- HERA (NCT06550063)
- Where
- Ireland
- Volunteers
- 2,188 people
- Sponsor
- St. James's Hospital, Ireland
HER2 Low Breast Cancers
Clinicopathological Parameters of HER2 Low Breast Cancers
This was a retrospective cohort study which included all histologically proven cases of breast cancer in the 2 years from January 2022- December 2023 at a tertiary care centre.
- Trial name
- NCT06433804
- Testing
- HER2 IHC
- Where
- India
- Volunteers
- 70 people
- Sponsor
- Vardhman Mahavir Medical College And Safdarjung Hospital
Hormone-receptor-positive Breast Cancer, HER2-low Breast Cancer
Study of Predictors of Clinical Outcomes in Patients With HR+ and HER2-low/Negative Breast Cancer
There is a lack of data on clinical and patient factors that are associated with poor survival in patients with HR+ and HER2-low/negative breast cancer treated with neoadjuvant chemotherapy or endocrine therapy.
- Conditions
- Hormone-receptor-positive Breast Cancer, HER2-low Breast Cancer, HER2-negative Breast Cancer
- Trial name
- NCT06040593
- Testing
- No drug
- Where
- United States
- Volunteers
- 927 people
- Sponsor
- Daiichi Sankyo
HER2-positive Breast Cancer, HER2 Low
ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer
This is an open-label, single-arm, multi-site phase I/Ib trial with SYD985, an antibody-drug conjugate (ADC) targeting HER2 on the cell membrane, combined with paclitaxel.
- Conditions
- HER2-positive Breast Cancer, HER2 Low, SYD-985, SYD985
- Trial name
- NCT04602117
- Testing
- Vic-trastuzumab duocarmazine (SYD985) + paclitaxel
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- QuantumLeap Healthcare Collaborative
Gastric Cancer, HER2-low-expressing Gastric Cancer
Posterior-line Treatment With Disitamab Vedotin Plus PD-1 in Advanced HER2-low Expressing Gastric Cancer
This is a single-arm, prospective, non-randomized, multi-center/single-center, open-label, phase I clinical study aimed at evaluating the efficacy and safety of Disitamab Vedotin in combination with PD-1 as posterior line…
- Trial name
- NCT06078982
- Testing
- Disitamab Vedotin, Toripalimab
- Where
- China
- Volunteers
- 39 people
- Sponsor
- Shanghai East Hospital
HR Positive/HER2 Low Expression Metastatic Breast Cancer
Disitamab Vedotin (RC48) in Hormone Receptor Positive, HER2-low Metastatic Breast Cancer (the Rosy Trial)
Hormone receptor positive, HER2-low expression metastatic breast cancer is the main type of breast cancer, accounting for about 50% - 60%.
- Trial name
- NCT05904964
- Testing
- Disitamab vedotin, Endocrine therapy
- Where
- 3 sites in China
- Volunteers
- 288 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University