Clinical trials: Breast-conserving Surgery
Breast Surgery, Lymph Node Excision
Safety & Performance of CANOpus PINtuition Surgical Marker Navigation
The goal of this clinical trial is to evaluate the safety and performance of the Canopus Marker in adult breast cancer patients who are scheduled for breast-conserving surgery. The main questions it aims to answer are: 1.
- Trial name
- CANOPIN (NCT06950021)
- Testing
- Magnetic seed
- Where
- Netherlands
- Volunteers
- 35 people
- Sponsor
- Sirius Medical Systems B.V.
Stage I Breast Carcinoma, Stage II Breast Carcinoma
Image-guided Breast Surgery in the Advanced Multimodality Image Guided Operating Suite (AMIGO)
This research study is a pilot study designed to evaluate magnetic resonance imaging-guided therapy (MRT) as a possible treatment for breast cancer.
- Trial name
- NCT02057432
- Testing
- intra-operative MRI
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer, Breast Surgery
Evaluation of the Effect of Antibiotic Prophylaxis During Lumpectomy for Breast Cancer: Prospective Randomised Double-blind Noninferiority Study of Placebo vs Cefazolin
The goal of this clinical trial is to determine whether preoperative antibiotic prophylaxis with cefazolin is necessary to prevent surgical site infections in adult women undergoing breast-conserving surgery (lumpectomy or…
- Conditions
- Breast Cancer, Breast Surgery, Surgical Site Infection (SSI), Surgical Site Infection Prevention
- Trial name
- PROPHY-SEIN (NCT07898943)
- Testing
- Cefazolin 2 g Infusion
- Where
- 33 sites in France
- Volunteers
- 1,600 people
- Sponsor
- University Hospital, Clermont-Ferrand
Breast Cancer Radiation
The PRECISION Trial (Profiling Early Breast Cancer for Radiotherapy Omission): A Phase II Study of Breast-Conserving Surgery Without Adjuvant Radiotherapy for Favorable-Risk Breast Cancer
This research study is a way of gaining new knowledge about whether patients can omit radiation treatment after undergoing a lumpectomy, also known as "breast conserving surgery".
- Trial name
- NCT02653755
- Testing
- Prosigna
- Where
- 6 sites in United States
- Volunteers
- 671 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer, Breast-Conserving Surgery
IntraOperative UltraSound Guided vs Wire Guided vs Magnetic Seed Guided Breast-Conserving Surgery for Non-palpable Tumors
This is a multi-center, randomized, open-label clinical trial that will enroll 1302 adult patients with non-palpable breast lesions.
- Trial name
- MANOLA (NCT07185568)
- Testing
- IOUS HydroMark™, Magnetic Sirius Pintuition Seed®, Wire localization (WL)
- Where
- 5 sites in Italy
- Volunteers
- 1,302 people
- Sponsor
- Istituto Oncologico Veneto IRCCS
Breast Cancer, Sentinel Lymph Node
Prospective Feasibility Study Applying the ACOSOG Z0011 Criteria to Chinese Patients
In patients undergoing breast-conserving surgery and having positive sentinel lymph nodes (SLNs), the ACOSOG Z0011 trial showed equivalent overall survival(OS) and disease-free survival(DFS) outcomes for patients receiving SLN…
- Conditions
- Breast Cancer, Sentinel Lymph Node, Local Recurrence of Malignant Tumor of Breast
- Trial name
- NCT03606616
- Testing
- no further ALND arm
- Where
- China
- Volunteers
- 142 people
- Sponsor
- Peking University People's Hospital
Breast Cancer
Implant-based Breast Reconstruction and Mastectomy With Fat Grafting After Breast Conserving Surgery and Radiotherapy
Higher rates of complications and poorer cosmetic outcomes have been reported after salvage mastectomy and implant-based versus autologous reconstruction in patients previously exposed to radiation therapy (i) on the breast as…
- Trial name
- NCT06119633
- Testing
- Immediate tissue expander and lipofilling after mastectomy
- Where
- 2 sites in Italy
- Volunteers
- 163 people
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Breast Cancer, Node-negative Breast Cancer
Partial Breast Irradiation Without Sentinel Lymph Node Biopsy in Low-Risk Early Breast Cancer
This is a multicenter, randomized, phase III non-inferiority trial in women aged 40 years or older with clinically node-negative (cN0), pathologically pT1 (≤2 cm), grade 1-2, lymphovascular invasion (LVI)-negative invasive breast…
- Conditions
- Breast Cancer, Node-negative Breast Cancer, Early-Stage Invasive Breast Carcinoma
- Trial name
- APROOB (NCT07757958)
- Testing
- Whole Breast Irradiation, Partial Breast Irradiation
- Where
- South Korea
- Volunteers
- 520 people
- Sponsor
- Samsung Medical Center
Breast-Conserving Surgery
Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision
This clinical trial evaluates the safety and efficacy of High Purity Type I Collagen scaffold for breast volume restoration following breast-conserving surgery (BCS).
- Trial name
- NCT07219316
- Testing
- High Purity Type I Collagen Scaffold (Regenerative Matrix)
- Where
- 2 sites in India
- Volunteers
- 40 people
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
Breast Cancer
A Study to Evaluate the Accuracy of a Breast Cancer Locator (BCL) in Patients With Palpable Cancers
In this study, the investigators will enroll women with palpable cancers to assess the accuracy of the Breast Cancer Locator (BCL) and the concomitant procedure as a vehicle to optimize and validate the approach in such surgical…
- Trial name
- NCT02550210
- Testing
- Breast Cancer Locator (BCL)
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Breast Cancer
A Prospective Cohort Study Evaluating Risk of Local Recurrence Following Breast Conserving Surgery and Endocrine Therapy in Low Risk Luminal A Breast Cancer
This is a multicentre, single-arm prospective cohort study evaluating risk of ipsilateral breast tumour recurrence(IBTR) following breast conserving surgery (BCS) in a group of women postulated to be at low risk for recurrence.
- Trial name
- LUMINA (NCT01791829)
- Where
- 27 sites in Canada
- Volunteers
- 500 people
- Sponsor
- Ontario Clinical Oncology Group (OCOG)
Breast Cancer Surgery, Breast Conserving Surgery
Erector Spinae Plane Block vs. PECS I-II Blocks After Breast-conserving Surgery
The goal of this study is to compare the analgesic effects of ESPB and PECS II blocks in patients undergoing BCS. The main question it aims to answer is: Whether these two different block procedures will create a difference in…
- Conditions
- Breast Cancer Surgery, Breast Conserving Surgery, Erector Spinae Plane Block, Pectoral Nerve (PECS) Block
- Trial name
- NCT06758765
- Testing
- Erector Spinae Plane Block, Pectoral Nerve Block
- Where
- Turkey (Türkiye)
- Volunteers
- 72 people
- Sponsor
- Istanbul Saglik Bilimleri University
Early Stage Breast Cancer, Breast Cancer Stage I
Evaluating Mass Spectrometry And Intraoperative MRI In The Advanced Multimodality Image Guided Operating Suite (Amigo) In Breast-Conserving Therapy
The purpose of this study is to investigate the use of intra-operative Magnetic Resonance Imaging (MRI) and Mass Spectrometry (MS) during breast conserving surgery, and to determine if these tests are capable of accurately…
- Conditions
- Early Stage Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II
- Trial name
- NCT02335671
- Testing
- Intra-operative Magnetic Resonance Imaging (MRI), Mass Spectrometer Analysis of Tissue Sample
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Dana-Farber Cancer Institute
Breast-Conserving Surgery, Negative Surgical Margins
Endoscopic Breast Conserving Surgery With Intra-operative Navigation System
A growing number of Chinese breast cancer patients are diagnosed at a young age. The quality of life of young breast cancer patients has been a critical issue.
- Conditions
- Breast-Conserving Surgery, Negative Surgical Margins, Endoscopy, Esthetics
- Trial name
- NCT05458414
- Testing
- Intra-operative Navigation System
- Where
- China
- Volunteers
- 41 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Untreated Human Epidermal Growth Factor Receptor-2(HER2)Positive Early Breast Cancer
Identification of Early Markers of Response and Resistance to Trastuzumab
The study is a single arm prospective study, aiming at identifying biomarkers of early response to trastuzumab. It is a prognostic factor study recruiting all consecutive cases of HER-2 positive breast cancer eligible for a…
- Trial name
- HERBIN (NCT01834950)
- Testing
- Blood test
- Where
- France
- Volunteers
- 25 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Breast Carcinoma
Trial Comparing Prone and Supine Intensity-modulated Radiotherapy (IMRT) After Breast-conserving Surgery in Patients With Large Breast Volume at High Risk for Skin Toxicity and Fibrosis
84 patients with a cup size C or more will be randomized to receive intensity-modulated radiotherapy in supine or prone position.
- Trial name
- NCT00887523
- Testing
- radiation in prone position, radiation in supine position
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- University Hospital, Ghent
Breast Cancer
Retrospective Evaluation of Ultrasound-assisted Tumor Surgery in Breast-conserving Therapy
The aim of this study is to evaluate whether standardizing intraoperative ultrasound (IOUS) with the "Tübingen Ultrasound Ruler" reduces R1 resection rates in breast-conserving surgery.
- Trial name
- MAC004 (NCT07519668)
- Where
- Germany
- Volunteers
- 273 people
- Sponsor
- University Hospital Tuebingen
Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7
Hypofractionated Radiation Therapy in Preventing Recurrence in Patients With Breast Cancer After Surgery
This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing the return of tumor cells in breast cancer patients following surgery.
- Conditions
- Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7
- Trial name
- NCT03324802
- Testing
- Hypofractionated Radiation Therapy, Quality-of-Life Assessment, Radiation Therapy
- Where
- 3 sites in United States
- Volunteers
- 107 people
- Sponsor
- Mayo Clinic
Breast Cancer, Seroma
EvaLuating negAtive pressUre Wound theRapy in brEast coNserving Surgery
Negative pressure wound therapy (NPWT) could improve surgical outcomes and reduce complications like SSI, wound dehiscence and seroma in closed surgical wounds.
- Conditions
- Breast Cancer, Seroma, Wound Complication
- Trial name
- LAUREN (NCT05509829)
- Testing
- Negative pressure wound therapy
- Where
- Netherlands
- Volunteers
- 300 people
- Sponsor
- Zuyderland Medisch Centrum
Breast Cancer
Ultrahypofractionated Versus Normofractionated Sequential Boost After Whole-breast Radiation Therapy in Patients Treated With Breast-conserving Surgery for Breast Cancer
The ULTIMO trial is a monocentric, prospective, randomised controlled, open-label, phase III interventional clinical trial, with a non-inferiority design, in patients with breast cancer undergoing breast conservative treatment…
- Trial name
- ULTIMO (NCT07590505)
- Testing
- Standard of Care (SOC) - Normofractionated Sequential Boost Radiation Therapy, Experimental - UltraHypofractionated Sequential Boost Radiation Therapy
- Where
- Belgium
- Volunteers
- 132 people
- Sponsor
- Cancer Research Antwerp