Clinical trials: HER2-Positive Early Breast Cancer, open to volunteers
Breast Cancer
CDK4/6 Inhibitor Intensification and Chemotherapy De-Escalation for Early-stage Luminal-HER2 Breast Cancer
The investigators designed a phase III clinical trial involving hormone receptor-positive and HER2-positive stage I breast cancer patients.
- Trial name
- Cinderella (NCT07213206)
- Testing
- CDK 4/6 inhibitor combined therapy (omit chemo), standard of care
- Volunteers
- 1,500 people
- Sponsor
- Fudan University
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
Breast Cancer Stage III, Breast Cancer Stage II
The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment
To explore the efficacy and safety of CDK4/6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive/HER2-negative breast cancer.
- Trial name
- NCT06810492
- Testing
- Ribociclib; abemaciclib; palbociclib; Dalpiciclib
- Volunteers
- 40 people
- Sponsor
- Hongmei Zheng, PhD
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial
This phase II trial tests reduced post surgery (adjuvant) therapy for patients with early breast cancer who have confirmed that the disease has responded completely (pathologic complete response) after pre surgical treatment…
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Early Stage HER2-Positive Breast Carcinoma, Early Stage Triple-Negative Breast Carcinoma
- Trial name
- NCT07407920
- Testing
- Biospecimen Collection, Hormone Therapy, Pembrolizumab
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- M.D. Anderson Cancer Center
Early-stage Breast Cancer, Hormone Receptor Positive Breast Carcinoma
Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer
This phase II trial investigates how well trastuzumab deruxtecan works alone or in combination with anastrozole in treating patients with HER2 low, hormone receptor positive breast cancer.
- Conditions
- Early-stage Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Invasive Breast Cancer, Stage II Breast Cancer
- Trial name
- NCT04553770
- Testing
- Anastrozole, Therapeutic Conventional Surgery, Trastuzumab Deruxtecan
- Where
- 9 sites in United States
- Volunteers
- 88 people
- Sponsor
- Jonsson Comprehensive Cancer Center
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
De-escalation Therapy in Stage I ER-Positive Breast Cancer: A Non-Inferiority Trial
This study is a prospective, randomized, open-label, non-inferiority Phase III clinical trial, planning to enroll 2,934 patients, with a 1:1 allocation to either the conventional endocrine therapy group or the de-escalation…
- Trial name
- DESCENT (NCT07153757)
- Testing
- Endocrine Therapy of Physician's Choice
- Where
- China
- Volunteers
- 2,934 people
- Sponsor
- Fudan University
Early Breast Cancer, HER2 + Breast Cancer
SHR-A1811 for HER2-positive Breast Cancer With Suboptimal Neoadjuvant Response
This is an open-label, single-arm, multicenter clinical study to evaluate the efficacy and safety of SHR-A1811 in early or locally advanced HER2-positive breast cancer patients with suboptimal response to neoadjuvant regimen.
- Conditions
- Early Breast Cancer, HER2 + Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
- Trial name
- NCT07129187
- Testing
- SHR-A1811
- Volunteers
- 30 people
- Sponsor
- Chuan Wang
Cardiovascular Health, Breast Cancer
JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year
This study focuses on male and female patients being treated for breast cancer that is positive for the HER2 receptor which requires special treatments targeting that receptor.
- Conditions
- Cardiovascular Health, Breast Cancer, Breast Cancer Early Stage Breast Cancer (Stage 1-3), Cardio-oncology
- Trial name
- JUSTIFY (NCT06930521)
- Testing
- Intervention - Low Risk Group OR Intermediate Risk Group
- Where
- Canada
- Volunteers
- 300 people
- Sponsor
- Women's College Hospital
Breast Cancer Female, Endocrine Therapy
The Benefits of Continued Use of Ovarian Function Suppression After 5 Years
To observe and evaluate the clinical efficacy and safety of continuous use of OFS for premenopausal patients with early breast cancer after 5 years use of OFS.
- Trial name
- NCT06050109
- Testing
- OFS continues to use group after 5 years use, Immunohistochemical detection of HR status
- Where
- China
- Volunteers
- 1,200 people
- Sponsor
- Hongmei Zheng, PhD
Breast Neoplasms, Breast Cancer
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early…
- Conditions
- Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma
- Trial name
- I-SPY (NCT01042379)
- Testing
- Standard Therapy, AMG 386 with or without Trastuzumab, AMG 479 (Ganitumab) plus Metformin
- Where
- 42 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- QuantumLeap Healthcare Collaborative
HER2-positive Breast Cancer
Pyrotinib in Women With High-risk in Early Stage Breast Cancer
ExteNET study explored neratinib prolong anti-HER2 therapy after trastuzumab therapy found that it can improve disease-free survival in patients with lymph nodes positive; In addition, the subgroup of patients with residual…
- Trial name
- NCT05834764
- Testing
- Pyrotinib
- Where
- China
- Volunteers
- 188 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Breast Cancer
Dalpiciclib With or Without Entinostat and Letrozole in HR+/HER2- Early Breast Cancer
Brief Summary This is an open-label, randomized, phase II clinical study designed to evaluate neoadjuvant treatment regimens in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative…
- Trial name
- NCT07492394
- Testing
- entinostat, Dalpiciclib, Letrozole
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Hebei Medical University Fourth Hospital
Breast Cancer
A Phase II Clinical Study of Treatment With Disitamb Vedotin Plus Pyrotinib in HER2-positive Early Breast Cancer
Evaluate the efficacy and safety of Disitamb Vedotin combined with pyrotinib in HER2 positive early breast cancer
- Trial name
- NCT06001086
- Testing
- Disitamb Vedotin ,pyrotinib
- Where
- China
- Volunteers
- 70 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Breast Cancer (Early Breast Cancer)
ADC Based Therapy Accroding to HER2 Heterogeneous
This study adopts a single-center, open-label, single-arm interventional design. It will enroll 88 patients with histologically confirmed HER2-positive early breast cancer who are suitable for surgery and neoadjuvant therapy, and…
- Trial name
- HER2level (NCT07844018)
- Testing
- HER2 target therapy
- Where
- China
- Volunteers
- 88 people
- Sponsor
- Peking University People's Hospital
Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer
A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment
The purpose of this study is to evaluate treatment adherence, tolerability, and patient-reported outcomes of participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast…
- Conditions
- Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer
- Trial name
- kalitERA (NCT07827573)
- Testing
- Giredestrant
- Where
- Canada
- Volunteers
- 1,500 people
- Sponsor
- Hoffmann-La Roche
Early Breast Cancer, Adjuvant Therapy
Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients
This study aims to evaluate the efficacy and safety of adjuvant endocrine therapy combined with dalpiciclib at different doses and durations in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast…
- Conditions
- Early Breast Cancer, Adjuvant Therapy, Hormone Receptor Positive / HER2-negative Breast Cancer
- Trial name
- NCT07101159
- Testing
- Dalpiciclib, Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
- Volunteers
- 200 people
- Sponsor
- Fujian Cancer Hospital
HER-2 Positive Breast Cancer
Phase II Study of Ultrasound and ctDNA Guided Neoadjuvant Systemic Therapy for Patients With HER2-positive Early Breast Cancer (UC HER Trial)
Although neoadjuvant dual anti-HER2-targeted therapy, pertuzumab and trastuzumab, combined with taxanes increased the pCR rate for patients with early-stage HER2-positive breast cancer when compared with single blockade combined…
- Trial name
- UC HER (NCT07565324)
- Testing
- Lipo-Dox®, Cyclophosphamide, Trastuzumab (Herceptin)
- Where
- Taiwan
- Volunteers
- 54 people
- Sponsor
- National Taiwan University Hospital
Breast Cancer
Impact of Intermittent Fasting on Biomarkers of Inflammation and Health-Related Quality of Life: A Feasibility Trial for Women With HR+/HER2- Early Breast Cancer
This single-arm study is designed to test the hypothesis that a six-month intermittent fasting (IF) intervention is feasible for patients to adhere to and improves health-related quality of life while subjects are on adjuvant…
- Trial name
- NCT06106477
- Testing
- Intermittent Fasting
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical College of Wisconsin
SHR-A1811, HER2-Postive Breast Cancer
SHR-A1811 Plus Pertuzumab as Neoadjuvant Therapy for Early or Locally Advanced HR-Positive HER2-Positive Breast Cancer: A Prospective, Open-Label, Phase II Study
Breast cancer is the most common malignancy in women, with approximately 20% classified as HER2-positive. Anti-HER2 blockade (trastuzumab plus pertuzumab) combined with chemotherapy constitutes the standard neoadjuvant regimen…
- Conditions
- SHR-A1811, HER2-Postive Breast Cancer, HR+ Breast Cancer, Early Breast Cancer
- Trial name
- NCT07307287
- Testing
- SHR- A1811
- Volunteers
- 30 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Breast Neoplasm, Breast Cancer
Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for…
- Conditions
- Breast Neoplasm, Breast Cancer, Breast Tumors, Triple-Negative Breast Cancer (TNBC)
- Trial name
- FASCINATE-N (NCT05582499)
- Testing
- Dalpiciclib, Pyrotinib, SHR-A1811
- Where
- China
- Volunteers
- 716 people
- Sponsor
- Fudan University