Clinical trials: Breast Surgery
Bone Metastases
A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone metastases in subjects with advanced breast cancer.
- Trial name
- NCT00321464
- Testing
- Denosumab, Zoledronic Acid
- Volunteers
- 2,049 people
- Sponsor
- Amgen
Breast Cancer
Breast Cancer Margin Delineation Using Polarization Subtraction Imaging Technology
This study will evaluate LumaScan, an innovative polarization microscope for real time, intraoperative imaging and evaluation of the surface of excised tissue excised during Breast Conservation Surgery (BCS) for non invasive and…
- Trial name
- NCT02207179
- Testing
- LumaScan Image Guided Surgery
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- LumaMed
Early Breast Cancer
A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1)
This is a multi-center, open-label Phase II randomized pre-surgical pharmacodynamics study.
- Trial name
- MONALEESA-1 (NCT01919229)
- Testing
- LEE011 (ribociclib), letrozole
- Where
- 7 sites in United States, Singapore and 1 more
- Volunteers
- 14 people
- Sponsor
- Novartis Pharmaceuticals
Blood Transfusion, Blood Transfusion, Autologous
A Study to Determine the Effectiveness of Epoetin Alfa in Facilitating Self-donation of Blood Before Surgery in Non-anemic Patients Who Are Undergoing Orthopedic, Heart and Blood Vessel, or Breast Reduction Surgery; Performed in Combination With a Procedure to Reduce Blood Loss During Surgery.
The purpose of this study is to determine the safety and effectiveness of epoetin alfa and whether epoetin alfa will enable self-donation of blood during an 11-day period before surgery (which is shorter than the conventional…
- Conditions
- Blood Transfusion, Blood Transfusion, Autologous, Orthopedic Procedures, Orthopedic Surgery
- Trial name
- NCT00270023
- Testing
- epoetin alfa
- Volunteers
- 112 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Capsular Contracture of Breast Implant
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Clinically Significant Capsular Contracture
This prospective breast implant surveillance cohort will evaluate whether implant age, pocket plane, incision route, surface texture, and volume predict clinically significant capsular contracture.
- Trial name
- NCT07810231
- Testing
- Breast Implant Exposure, Standardized Capsular Contracture Assessment
- Where
- Colombia
- Volunteers
- 3,000 people
- Sponsor
- Research Inc
Cutaneous Breast Cancer
Efficacy and Safety Study of REM-001 Photodynamic Therapy for Treatment of Cutaneous Metastatic Breast Cancer (CMBC)
This is an open-label, single cohort study to confirm dose, assessments and timing of response, to support future studies. The primary objective of the trial is to evaluate cutaneous tumor response within total target treatment…
- Trial name
- NCT05374915
- Testing
- REM-001 photodynamic therapy
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Kintara Therapeutics, Inc.
Breast Cancer
Pilot Study to Evaluate Safety & Biological Effects of Orally Administered Reparixin in Early Breast Cancer
This is a pilot "window of opportunity" clinical study in patients with operable breast cancer investigating use of reparixin as single agent in the time period between clinical diagnosis and surgery.
- Trial name
- NCT01861054
- Testing
- Reparixin
- Where
- 9 sites in United States
- Volunteers
- 20 people
- Sponsor
- Dompé Farmaceutici S.p.A
Breast Cancer
Anti-tumour Effects & Tolerability of Faslodex Alone or in Combination With Arimidex in Post Menopausal Women Prior to Surgery for Primary Breast Cancer
To compare the anti-tumour effects as measured by changes in various biomarkers, of a combination of Faslodex and Arimidex with Faslodex alone and Arimidex alone in postmenopausal women patients with primary breast cancer who are…
- Trial name
- NCT00259090
- Testing
- Fulvestrant, Anastrazole
- Where
- United Kingdom
- Volunteers
- 120 people
- Sponsor
- AstraZeneca
Breast Cancer
Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas
Non-randomized, Single Arm Clinical study to Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas
- Trial name
- NCT02794558
- Testing
- ExAblate MRgFUS
- Where
- Japan
- Volunteers
- 91 people
- Sponsor
- InSightec
Breast Neoplasms
The Breast Surgery EnLight and LightPath Imaging System Study
This study will correlate the resection margin status of the breast cancer tumour (WLE specimen), cavity shavings (if any) and breast cavity, and the metastatic status of axillary lymph nodes as determined by EnLight, LightPath…
- Trial name
- NCT02151071
- Testing
- EnLight, LightPath
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Lightpoint Medical Limited
Breast Cancer, Lung Cancer
hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse
This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity of INO-1400 or INO-1401 alone or in combination with INO-9012, delivered by electroporation in subjects with high-risk solid tumor…
- Conditions
- Breast Cancer, Lung Cancer, Pancreatic Cancer, Head and Neck Cancer
- Trial name
- TRT-001 (NCT02960594)
- Testing
- INO-1400, INO-9012, INO-1401
- Where
- 6 sites in United States
- Volunteers
- 93 people
- Sponsor
- Inovio Pharmaceuticals
Reduction of Hypertrophic Skin Scarring
Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery
The study will compare how well PF-06473871 works versus placebo in reducing skin scarring after scar revision surgery of existing breast scars. The study will also evaluate the safety of PF-06473871 in healthy adult subjects.
- Trial name
- NCT01730339
- Testing
- PF-06473871
- Where
- 40 sites in United States, Germany and 2 more
- Volunteers
- 103 people
- Sponsor
- Pfizer
Radiodermatitis
Exploratory Study of Topical Norepinephrine in Breast Cancer Patients Receiving Radiotherapy
This study, a nonrandomized open-label safety and exploratory study, will evaluate the safety of topical norepinephrine in post-surgical breast cancer patients who are undergoing radiation therapy.
- Trial name
- NCT01544504
- Testing
- Norepinephrine
- Where
- United States
- Sponsor
- ProCertus BioPharm, Inc
Breast Cancer, Radiation Dermatitis
A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer
The purpose of this study is to evaluate the effects of topical R1 and R2 for prophylaxis of acute radiation dermatitis in patients with breast cancer receiving radiotherapy.
- Conditions
- Breast Cancer, Radiation Dermatitis, Erythema
- Trial name
- NCT01597921
- Where
- Israel
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Water-Jel
Breast Cancer
SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery
This is a multicenter, first-in-human (FIH), open label, Phase 1 dose escalation and recommended Phase 2 dose (RP2D) extension trial with a primary objective to define the RP2D of SRG-514 when administered intraoperatively to…
- Trial name
- NCT06300411
- Testing
- SRG-514
- Where
- 8 sites in United States
- Volunteers
- 25 people
- Sponsor
- SURGE Therapeutics
Margin Assessment, Breast Cancer
Spectral Cancer Tissue Recognition - I
This analytical performance study aims to validate the SPCTRone system for use in breast conserving surgery of breast cancer patients.
- Trial name
- SPCTR-I (NCT07459062)
- Where
- 2 sites in Netherlands
- Volunteers
- 100 people
- Sponsor
- SPCTR
Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy
BIOCHROMADERM® PMCF STUDY
The goal of this observational study is to: To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation; To confirm the…
- Trial name
- NCT07261904
- Where
- 3 sites in France
- Volunteers
- 115 people
- Sponsor
- Laboratoires BIOTIC Phocea
Breast Implant Revision, Breast Augmentation Complications
Scaffold-guided Breast Implant Revision and Primary Breast Augmentation Surgery
The objective of the clinical investigation is to demonstrate safety and clinical performance of the absorbable polycaprolactone (PCL) breast scaffold combined with autologous fat grafting (AFG) for primary breast augmentation…
- Conditions
- Breast Implant Revision, Breast Augmentation Complications, Primary Breast Augmentation Surgery
- Trial name
- NCT07367698
- Testing
- Implantation of the PCL Breast scaffold with autologous fat grafting
- Where
- 3 sites in Australia
- Volunteers
- 87 people
- Sponsor
- BellaSeno Pty Ltd
Breast Cancer Female
Wide-field Optical Coherence Tomography Imaging of Excised Breast Tissue.
This is a single-arm, multi-center data collection study designed to collect WF-OCT imaging data of excised breast tissue margins with corresponding margin status from histopathology.
- Trial name
- NCT04242277
- Testing
- Investigational WF-OCT device
- Where
- 2 sites in United States
- Volunteers
- 198 people
- Sponsor
- Perimeter Medical Imaging
Breast Cancer, Reconstructive Breast Surgery
Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
This study will evaluate the effect of OxyGenesys Dissolved Oxygen Dressing in wound complication rates of the nipple areolar complex after a nipple sparing mastectomy.
- Trial name
- NSM (NCT01796977)
- Testing
- OxyGenesys Dissolved Oxygen Dressing, Standard Gauze Dressing
- Where
- 7 sites in United States
- Volunteers
- 27 people
- Sponsor
- Halyard Health