Clinical trials: HER2-low Breast Cancer
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
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)
Locally Advanced Breast Cancer (LABC)
Pyrotinib Maleate Tablets in Combination With Dalpiciclib Isethionate Tablets and Standard Endocrine Therapy
This study is a prospective, exploratory clinical study design, and plans to enroll 33 patients with HR+HER2 low expression breast cancer who received pyrotinib combined with darcili and standard endocrine neoadjuvant therapy to…
- Trial name
- NCT07189884
- Testing
- Pyrotinib Maleate Tablets + Dalpiciclib Isethionate Tablets + Standard Endocrine
- Volunteers
- 33 people
- Sponsor
- The First Affiliated Hospital of Xiamen University
Advanced Metastatic Breast Cancer
Analysis of Circulating Tumor DNA (ctDNA) in HER2-low Advanced/Metastatic Breast Cancer
A Pilot study on circulating tumor DNA (ctDNA) in advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low)
- Trial name
- LEGO (NCT06706557)
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- European Institute of Oncology
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
HER2/Neu Positive, Progesterone Receptor Positive
Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer
This randomized phase III clinical trial studies chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer.
- Conditions
- HER2/Neu Positive, Progesterone Receptor Positive, Recurrent Breast Carcinoma, Stage IA Breast Cancer AJCC v7
- Trial name
- NCT01275677
- Testing
- Cyclophosphamide, Docetaxel, Doxorubicin
- Where
- 1,283 sites in United States, Canada and 2 more
- Volunteers
- 3,270 people
- Sponsor
- National Cancer Institute (NCI)
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
Neoplasms, Breast Neoplasms
Phase I/II AZD8931/Paclitaxel in Treatment of Advanced Solid Tumours (Phase I) and Advanced Breast Cancer (Phase II)
The main purpose of this study is to determine if AZD8931 can improve the efficacy of standard chemotherapy for the treatment of advanced breast cancer.
- Conditions
- Neoplasms, Breast Neoplasms, Breast Cancer
- Trial name
- THYME (NCT00900627)
- Testing
- AZD8931, Paclitaxel
- Where
- 38 sites in Belgium, Brazil and 12 more
- Volunteers
- 330 people
- Sponsor
- AstraZeneca
Cancer
QUILT-3.013: Study of Ad5 [E1-, E2b-]-HER2/Neu Vaccine (ETBX-021) in Subjects With Unresectable Locally Advanced or Metastatic HER2-Expressing Breast Cancer
The purpose of this study is to determine whether ETBX-021 is safe and effective in the treatment of unresectable locally advanced or metastatic HER2-low-expressing breast cancer.
- Trial name
- NCT02751528
- Testing
- ETBX-021
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- NantBioScience, Inc.
HER2-positive Breast Cancer
Testing Radiation and HER2-targeted Therapy Versus HER2-targeted Therapy Alone for Low-risk HER2-positive Breast Cancer
This Phase III trial compares the recurrence-free interval (RFI) among patients with early-stage, low risk HER2+ breast cancer who undergo breast conserving surgery and receive HER2-directed therapy, and are randomized to not…
- Trial name
- HERO (NCT05705401)
- Testing
- Standard of Care Adjuvant Breast Radiation, Standard of Care HER2-targeted Therapy Without Adjuvant Breast Radiation
- Where
- 418 sites in United States, Puerto Rico
- Volunteers
- 1,300 people
- Sponsor
- NRG Oncology
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
Ductal Carcinoma In Situ, DCIS
Omission of Adjuvant Radiotherapy in Low- and Intermediate-Risk Ductal Carcinoma In Situ After Breast-Conserving Surgery
This is a prospective, multicenter, randomized, open-label, phase III non-inferiority trial designed to evaluate whether omission of postoperative radiotherapy is clinically acceptable in patients with low- and intermediate-risk…
- Trial name
- NCT07762885
- Testing
- Adjuvant Radiotherapy, tamoxifen
- Where
- China
- Volunteers
- 636 people
- Sponsor
- Fudan University
Breast Cancer
To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer
- Trial name
- NCT06389006
- Testing
- Disitamab Vedotin for Injection, Toripalimab, Epirubicin
- Where
- China
- Volunteers
- 79 people
- Sponsor
- RemeGen Co., Ltd.
Advanced Breast Cancer, Advanced Breast Carcinoma
Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype
This trial studies a type of advanced breast cancer defined as hormone receptor HR-positive/HER2-negative and classified as non-luminal by gene expression profiling (PAM50).
- Conditions
- Advanced Breast Cancer, Advanced Breast Carcinoma, Hormone Receptor Positive Breast Carcinoma
- Trial name
- PONTIAC (NCT06486883)
- Testing
- Trastuzumab deruxtecan (T-DXd, DS-8201a), CDK4/6i plus ET
- Where
- 79 sites in Austria, Belgium and 8 more
- Volunteers
- 200 people
- Sponsor
- MedSIR
Breast Cancer
Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of an adjuvant treatment of therapeutic cancer vaccine (AST-301, pNGVL3-hICD) in patients with HER2-low expression (IHC 1+ or 2+ and ISH-) and hormone…
- Trial name
- Cornerstone001 (NCT05163223)
- Testing
- AST-301(pNGVL3-hICD), rhuGM-CSF, Pembrolizumab
- Where
- 17 sites in United States, Taiwan
- Volunteers
- 10 people
- Sponsor
- Aston Sci. Inc.
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.
Breast Cancer, Breast Cancer With Low to Intermediate HER2 Expression
Application of Multimodal MRI-based Radiomics in Histological Grading and Prognostic Assessment of Breast Cancer
In addition to TNM staging, the current management of breast cancer is based on conventional pathological features that categorize the disease into three molecular subtypes, each with significant prognostic implications in…
- Trial name
- NCT07389200
- Testing
- DCE-MRI
- Volunteers
- 400 people
- Sponsor
- Hao Xu
Unresectable Breast Cancer, Metastatic Breast Cancer
HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada
Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-Breast trials and has a marketing authorization from Health Canada for patients with HER2-positive metastatic breast cancer (mBC) and HER2-low…
- Conditions
- Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer, HER2-positive Breast Cancer
- Trial name
- HER-TEMPO (NCT06386263)
- Testing
- Trastuzumab deruxtecan
- Where
- Canada
- Volunteers
- 22 people
- Sponsor
- AstraZeneca
Breast Cancer
Efficacy and Safety of T-DXd in Patients With HER2-positive and HER2-low Metastatic Breast Cancer: a Real-world Study
Evaluate the efficacy and safety of T-DXd in patients with HER2-positive and HER2-low metastatic breast cancer
- Trial name
- NCT07108595
- Testing
- T- Dxd
- Where
- China
- Volunteers
- 142 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical 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