Clinical trials: HER2 Low Breast Carcinoma
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
Breast Cancer
A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer
This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with…
- Trial name
- NCT06112379
- Testing
- Dato-DXd, Durvalumab, Pembrolizumab
- Where
- 283 sites in United States, Australia and 24 more
- Volunteers
- 1,902 people
- Sponsor
- AstraZeneca
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
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer
This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Locally Advanced Breast Carcinoma
- Trial name
- NCT07137416
- Testing
- Biopsy Procedure, Biospecimen Collection, Echocardiography Test
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- National Cancer Institute (NCI)
Breast Neoplasms, Breast Cancer
PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan
This is a prospective non-interventional, multicenter study observing patient reported outcomes as well as real-world efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with documented Human epidermal growth factor…
- Conditions
- Breast Neoplasms, Breast Cancer, Neoplasm Metastasis
- Trial name
- PROVIDENCE (NCT05573893)
- Where
- 109 sites in Germany
- Volunteers
- 800 people
- Sponsor
- AstraZeneca
Breast Cancer, HER2-low Breast Cancer
Distribution of the Homologous Recombination-related (HRR) Genesmutationsand HRD in Breast Cancer
This is a cross-sectional and an observational study, investigator-initiated study in HER2-low breast cancer patients. Approximately 255 subjects with HRD (homologous recombination deficiency) assessment will be enrolled in this…
- Trial name
- NCT05466786
- Testing
- Standard Management
- Where
- China
- Volunteers
- 255 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer
Use of Trastuzumab to Induce Increased ER Expression in ER-negative/Low, Her-2/Neu Positive Breast Cancer
The majority pf breast cancers present as ER-positive, many of which are able to be targeted with multiple hormonal therapies. Altering ER-negative tumors to increase ER expression has the potential to benefit patients by making…
- Trial name
- NCT00726180
- Testing
- trastuzumab (Herceptin®)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Michigan Rogel Cancer Center
HR Positive/HER2 Low Breast Cancer
Neoadjuvant Therapy Combined With Trastuzumab Rezetecan and Toripalimab for HR+/HER2-low Breast Cancer (NEOTORCH-BREAST 08)
This study is a prospective, multi-cohort, multicenter, open-label exploratory clinical trial. The primary study objective is to evaluate the pathologic complete response (PCR) of treatment of HR+/HER2-low breast cancer with…
- Trial name
- NCT07383818
- Testing
- Neoadjuvant therapy combined with Trastuzumab Rezetecan and Toripalimab, Neoadjuvant Chemotherapy in Combination with Toripalimab, Neoadjuvant Chemotherapy
- Where
- 5 sites in China
- Volunteers
- 111 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
HER2-addicted Breast Cancer
Trial of Retifanlimab With Trastuzumab and Pertuzumab Combination in HER2-Addicted Breast Cancer
The goal of this Clinical Trial is to find out how well 3 medicines (retifanlimab, trastuzumab and pertuzumab) work at treating HER2-positive breast cancer in Male and female patients, 18 or older.
- Trial name
- RTP (NCT07772245)
- Testing
- Retifanlimab, Trastuzumab (Herceptin), Pertuzumab
- Volunteers
- 30 people
- Sponsor
- Polly A. Niravath, MD
Breast Cancer
A Study of Pertuzumab in Participants With Metastatic Breast Cancer
This study will evaluate the efficacy and safety of pertuzumab (rhuMAb 2C4) in participants with metastatic breast cancer which has progressed during or after standard chemotherapy and which is not amenable to curative therapy.
- Trial name
- NCT02491892
- Testing
- Pertuzumab
- Where
- 18 sites in Australia, Belgium and 6 more
- Volunteers
- 79 people
- Sponsor
- Hoffmann-La Roche
Advanced/Metastatic Breast Cancer, HER2+, Low, or Ultralow Advanced/Metastatic Breast Cancer
Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer
This study aims to evaluate whether the combination of Megestrol Acetate at the initiation of Trastuzumab Deruxtecan (T-DXd) treatment can effectively prevent and alleviate T-DXd-related fatigue, thereby improving the quality of…
- Trial name
- MEGA-TACT-BC3 (NCT07543536)
- Testing
- Megestrol Acetate + Trastuzumab Deruxtecan
- Where
- 2 sites in China
- Volunteers
- 132 people
- Sponsor
- Sun Yat-sen 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
Cancers With HER2 Expression
A First in Human Study of BAY2701439 to Look at Safety, How the Body Absorbs, Distributes and Excretes the Drug, and How Well the Drug Works in Participants With Advanced Cancer Expressing the HER2 Protein
In this study, researchers want to learn about the safety of drug BAY2701439 and how well the drug works in patients with advanced cancer that has the protein HER2 (Human Epidermal growth factor Receptor 2) and cannot be cured by…
- Trial name
- NCT04147819
- Testing
- BAY2701439
- Where
- 6 sites in United States, United Kingdom
- Volunteers
- 14 people
- Sponsor
- Bayer
Breast Cancer
Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer
The purpose of this study is to evaluate the Safety and Efficacy of Neoadjuvant study of DV in combination Toripalimab i or sequence chemotherapy in HR-negative, HER2 low-expressing Breast Cancer
- Trial name
- NCT06227117
- Testing
- Disitamab Vedotin Injection （18 weeks）, Toripalimab （18weeks）, Carboplatin
- Where
- 5 sites in China
- Volunteers
- 120 people
- Sponsor
- RemeGen Co., Ltd.
Breast Neoplasms, Breast Cancer
Safety and Efficacy Study of the Trifunctional Antibody Ertumaxomab to Treat Patients With Advanced or Metastatic Breast Cancer
The purpose of this study is to determine the safety and efficacy of the investigational trifunctional anti-Her-2/neu x anti-CD3 antibody ertumaxomab as treatment for hormone therapy refractory Her-2/neu 1+ or 2+ expressing…
- Trial name
- IV REXBC 02 (NCT00351858)
- Testing
- ertumaxomab
- Where
- Belgium
- Volunteers
- 40 people
- Sponsor
- Neovii Biotech
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
Triple-Negative Breast Cancer
T-DXd in the First-Line Treatment of Locally Advanced or Metastatic TNBC-LAR HER2-low Patients
This is an open-label, single-arm phase II trial of first-line treatment with trastuzumab deruxtecan (T-DXd) for patients with locally advanced or metastatic triple-negative breast cancer, luminal androgen receptor subtype…
- Trial name
- NCT05953168
- Testing
- Trastuzumab Deruxtecan
- Where
- China
- Volunteers
- 69 people
- Sponsor
- Fudan University
Trastuzumab-rezetecan, HER2-low Breast Cancer
Efficacy and Safety of Trastuzumab-rezetecan in HER2-Expressing Breast Cancer
This study is a multicenter, observational, real-world investigation. The research plans to enroll 300 HER2-positive and HER2-low breast cancer patients who meet the inclusion criteria.
- Conditions
- Trastuzumab-rezetecan, HER2-low Breast Cancer, HER2-positive Breast Cancer
- Trial name
- NCT07358182
- Testing
- Trastuzumab-rezetecan Treatment Group
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Female Breast Cancer
PROOFS-Registry - Premenopausal Women With Breast Cancer Optimally Treated With OFS
There is only limited data for premenopausal patients in general, as well as for differences in the use of OFS in the subgroups of pre- and perimenopausal patients, respectively.
- Trial name
- PROOFS (NCT05792150)
- Where
- 71 sites in Germany
- Volunteers
- 1,470 people
- Sponsor
- Women's Cancer Study Group GmbH
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