Clinical trials: Early Breast Cancer, open to volunteers
Early Breast Cancer
Refusal of Sentinel Lymph Node Biopsy in Patients With Luminal A Subtype Early Breast Cancer
Sentinel lymph node biopsy (SLNB) is the standard of axillary lymph node surgical staging in patients with early breast cancer. The main goal of the study is to abandon axillary surgery in patients over 59 years old with early…
- Trial name
- LumiNOde (NCT07579286)
- Testing
- breast resection, Breast resection with sentinel lymph node biopsy
- Where
- Russia
- Volunteers
- 100 people
- Sponsor
- N.N. Petrov National Medical Research Center of Oncology
Breast Cancer
FREDO-ODX Study: FREnch Data on Outcomes in HR+/HER2- Early Breast Cancer Patients With oncotypeDX Recurrence Score-guided Therapy
The aim of this study is to assess the clinical outcomes in real-life setting of early breast cancer RH+ HER2- patients with systemic therapy guided by Oncotype DX (ODX) Breast Recurrence Score®.
- Trial name
- FREDO-ODX-23 (NCT06185569)
- Where
- 5 sites in France
- Volunteers
- 4,500 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
TNBC - Triple-Negative Breast Cancer
Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer
ICK-breast is a prospective, multicentric, non-interventional investigator-initiated trial (IIT) that aims to investigate the prognostic value of CRP kinetics in early and advanced or metastatic triple negative breast cancer…
- Trial name
- NCT05914961
- Where
- Germany
- Volunteers
- 225 people
- Sponsor
- University Hospital Tuebingen
Leucogen, Ribociclib
the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Breast Cancer
This study is a multicenter, single-arm, open-label Phase II exploratory clinical trial designed to evaluate whether prophylactic use of leucogen can reduce the incidence of Grade 3 or higher neutropenia in early-stage HR+/HER2…
- Conditions
- Leucogen, Ribociclib, Neutropenia (Low White Blood Cell Count), Breast Cancer
- Trial name
- NCT07380646
- Testing
- Treat Regimen
- Where
- China
- Volunteers
- 97 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Triple Negative Breast Cancer (TNBC), Early Setting
Diet-drive Gut Microbiome and Outcome in Patients With Early-stage Triple-negative Breast Cancer Undergoing Neoadjuvant Chemotherapy and Immunotherapy.
CAPTIVATE is a multi-center translational and observational trial, that aims to investigate the impact of the gut microbiome on treatment outcomes in women with untreated, stage I-III Triple Negative undergoing neoadjuvant…
- Trial name
- CAPTIVATE (NCT07551765)
- Where
- United Kingdom
- Volunteers
- 300 people
- Sponsor
- Barts & The London NHS Trust
Advanced/Metastatic Breast Cancer, Breast Cancer (Early Breast Cancer)
Praegnant Breast Cancer: Early/Advanced/Metastatic
Among patients with breast cancer the subgroup of patients with metastases are considered the group of patients with the worst prognosis.
- Trial name
- PRAEGNANT (NCT02338167)
- Testing
- Blood sampling
- Where
- 61 sites in Germany
- Volunteers
- 13,500 people
- Sponsor
- University Hospital Tuebingen
Breast Cancer
Trastuzumab/Pertuzumab With Fulvestrant and Culmerciclib in HR+/HER2+ Early Breast Cancer
This phase II single-arm study is designed to evaluate the neoadjuvant efficacy of a chemotherapy-free regimen consisting of trastuzumab, pertuzumab, Culmerciclib, and fulvestrant in patients with treatment-naïve stage II-III…
- Trial name
- NCT07857226
- Testing
- Trastuzumab (or biosimilar), Pertuzumab, Culmerciclib
- Volunteers
- 31 people
- Sponsor
- Hebei Medical University Fourth Hospital
Breast Cancer, DCIS
Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer
This trial will investigate a novel 3-fraction radiation regimen for participants undergoing breast-conserving therapy (BCT) for early breast cancer that will: 1) significantly reduce the duration of treatment and can be…
- Conditions
- Breast Cancer, DCIS, LCIS
- Trial name
- MAPBI (NCT03936478)
- Testing
- MRIdian Radiation Treatment Unit
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Wisconsin, Madison
Breast Cancer, Invasive Carcinoma of Breast
5 vs. 9-day Course of Whole Breast Radiotherapy With Boost for Early-stage Breast Cancer
The goal of this study is to evaluate 5 days vs. 9 days of whole breast radiation.
- Conditions
- Breast Cancer, Invasive Carcinoma of Breast, Ductal Breast Carcinoma in Situ
- Trial name
- FAST NOVEMBER (NCT06961955)
- Testing
- Radiation Therapy
- Where
- United States
- Volunteers
- 144 people
- Sponsor
- University of Utah
Cancer Colon, Cancer, Liver
Clinical Validation of an MCED Test in Symptomatic Populations (K-ACCELERATE)
To evaluate the diagnostic performance of blood-based SPOT-MAS test in symptomatic individuals, the investigators sought to launch a prospective multicenter study, named K-ACCELERATE.
- Conditions
- Cancer Colon, Cancer, Liver, Cancer, Lung, Cancer, Breast
- Trial name
- K-ACCELERATE (NCT06391749)
- Where
- Vietnam
- Volunteers
- 1,000 people
- Sponsor
- Gene Solutions
HER2-positive Early Breast Cancer
Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer
This prospective, response-guided phase II study investigates individualized neoadjuvant treatment strategies for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.
- Trial name
- TAYLOR (NCT07340398)
- Testing
- Nab paclitaxel, Carboplatin, Trastuzumab
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
HER2-positive Breast Cancer, Breast Cancer
A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer
- Trial name
- EmpowHER 208 (NCT07102381)
- Testing
- Zanidatamab, Paclitaxel, Docetaxel
- Where
- 53 sites in United States, Germany and 2 more
- Volunteers
- 125 people
- Sponsor
- Jazz Pharmaceuticals
TNBC
A Single-Arm, Single-Center, Phase II Clinical Study of Camrelizumab Combined With Radiochemotherapy as Neoadjuvant Therapy for Early-Stage Triple-Negative Breast Cancer
Camrelizumab + Chemoradiotherapy for Early TNBC Sponsor/Leading Center: Tianjin Medical University Cancer Institute and Hospital Study Type: Single-arm, single-center, Phase Ⅱ clinical study Planned Enrollment: 43 patients…
- Trial name
- NCT07491822
- Testing
- treatment group
- Volunteers
- 43 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Breast Neoplasm Female
SBRT in Early Breast Cancer in Elderly Women
Surgical treatment represents the standard of local therapy in patients with early breast cancer, however in women over75, the comorbidities related to aging reduce the possibility of candidates for surgical treatment.
- Trial name
- NCT05071105
- Testing
- Stereotactic Body Radiation Therapy
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- University of Rome Tor Vergata
TNBC, Triple Negative Breast Cancer
TREND-02 - a Phase II Exploratory De-escalation Trial of Neoadjuvant Sacituzumab Govitecan Plus Tislelizumab (SG/I) in Early Triple-negative Breast Cancer
Refining neoadjuvant chemoimmunotherapy and establishing predictive biomarkers remain pivotal challenges in early TNBC. Although SG/I (sacituzumab govitecan/PD-1 inhibitor) shows clinical promise, validation of responder…
- Trial name
- TREND-02 (NCT07271992)
- Testing
- SG+I
- Volunteers
- 30 people
- Sponsor
- First Hospital of China Medical University
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
SHR-A1811 Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC
The goal of this clinical trial is to evaluate the efficacy and safety of SHR-A1811 plus pertuzumab in combination with or without albumin-paclitaxel neoadjuvant therapy for early or locally advanced HER2-positive breast cancer.
- Trial name
- NCT06927180
- Testing
- SHR-A1811, Pertuzumab, Albumin-Paclitaxel
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Henan Cancer Hospital
HER2-positive Breast Cancer
De-escalation Neoadjuvant Therapy for Intermediate Risk HER2-positive Early Breast
High pathological complete response (pCR) rates are seen using different neoadjuvant chemotherapy schedules with trastuzumab and pertuzumab in HER2-positive stage II-III breast cancer patients.
- Trial name
- neoDIRHP (NCT07748260)
- Testing
- THP×4 Q3W (n=296) (Investigator-selected taxane* + Trastuzumab IV 6 mg/kg, loading dose 8 mg/kg + Pertuzumab IV 420 mg, loading dose 840mg), THP×6 Q3W (n=296) (Investigator-selected taxane* + Trastuzumab IV 6 mg/kg, loading dose 8 mg/kg + Pertuzumab IV 420 mg, loading dose 840mg)
- Volunteers
- 592 people
- Sponsor
- Guangdong Provincial People's Hospital
Breast Cancer, Clinically Assessed Negative Axillary Lymph Nodes
Omission of SLNB in CN0 Early Breast Cancer
The OMSLNB trial adopts a prospective, single-arm, non-inferiority, phase-II, open-label study design. Patients with unilateral invasive breast cancer （tumor ≤3cm） and assessed as cN0 will be eligible for inclusion, enrolled…
- Conditions
- Breast Cancer, Clinically Assessed Negative Axillary Lymph Nodes, Sentinel Lymph Node
- Trial name
- NCT05935150
- Testing
- Omit SLNB
- Where
- China
- Volunteers
- 311 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
HER2 + Breast Cancer
A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer
This is a study to compare the similarity in Pharmacokinetics (PK) profile of HLX319 vs. EU-Phesgo® in patients with HER2-positive early or locally advanced breast cancer .
- Trial name
- NCT07601620
- Testing
- HLX319, EU-Phesgo®
- Volunteers
- 258 people
- Sponsor
- Shanghai Henlius Biotech
TNBC, Triple Negative Breast Cancer
A Study of QL1706 Combined With Short-Cycle Anthracyclines or Taxanes for the Treatment of Early-Stage TNBC
Triple-negative breast cancer (TNBC) accounts for about 20% of breast cancers, is poorly differentiated, progresses rapidly, and frequently recurs, making it the subtype with the worst prognosis.
- Trial name
- NCT07178171
- Testing
- QL1706 (bispecific antibody targeting PD-1 and CLTA-4), Pirarubicin, Nab-paclitaxel
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Xijing Hospital