Clinical trials: Surgery of Breast Cancer
Breast Cancer Female
Brevera™ Breast Biopsy System Data Collection Study
The Brevera Breast Biopsy System integrates tissue acquisition, real time imaging, and post biopsy handling all during the same procedure.
- Trial name
- NCT03456583
- Testing
- Brevera Breast Biopsy System
- Where
- 6 sites in France, Germany and 4 more
- Volunteers
- 500 people
- Sponsor
- Hologic, Inc.
TNBC - Triple-Negative Breast Cancer
Phase 3 Trial of SRG-514 Administered Intraoperatively to Patients Undergoing Breast-Conserving Surgery
This is a Phase 3 trial to compare SRG-514 (active pharmaceutical ingredient [API]: ketorolac) administered intraoperatively to the tumor resection cavity with standard-of-care (SOC) versus SOC alone in participants with clinical…
- Trial name
- NCT07723469
- Testing
- BCS + SRG-514, BCS
- Where
- 3 sites in United States
- Volunteers
- 400 people
- Sponsor
- SURGE Therapeutics
Breast Cancer, Head and Neck Squamous Cell Carcinoma
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine…
- Conditions
- Breast Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Prostate Cancer
- Trial name
- NCT03735680
- Testing
- ONM-100
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- OncoNano Medicine, Inc.
Secondary Lymphedema
A Phase I Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema
Indicated for the Treatment of Secondary Lymphedema Associated with the Treatment of Breast Cancer. Primary objective is to evaluate the safety and tolerability of a single dose of Lymfactin® in patients with secondary lymphedema…
- Trial name
- NCT02994771
- Testing
- Lymfactin® [1 x 10E10 vp], Lymfactin® [1 x 10E11 vp]
- Where
- 3 sites in Finland
- Volunteers
- 15 people
- Sponsor
- Herantis Pharma Plc.
Triple Negative Breast Cancer
A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer
This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in…
- Trial name
- NCT02032277
- Testing
- Cyclophosphamide, Doxorubicin, Paclitaxel
- Where
- 158 sites in United States, Australia and 13 more
- Volunteers
- 634 people
- Sponsor
- AbbVie
Breast Neoplasm Female, Breast Cancer
Fluorescence Imaging of Carcinoma During Breast Conserving Surgery
Breast conserving surgery (BCS) is performed on patients with breast cancer to resect and completely remove the cancer while conserving as much of the surrounding healthy tissue as possible.
- Trial name
- NCT04815083
- Testing
- Aminolevulinic Acid Hydrochloride, Eagle V1.2 Imaging System
- Where
- 7 sites in United States
- Volunteers
- 57 people
- Sponsor
- SBI ALApharma Canada, Inc.
Lymphedema, Lymphedema, Breast Cancer
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of the Dayspring Technology for Patients With Breast Cancer Related Lymphedema (BCRL) After Lymphatic Surgery
To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery
- Conditions
- Lymphedema, Lymphedema, Breast Cancer, Lymphedema Arm
- Trial name
- TIGRIS (NCT04888975)
- Testing
- Dayspring Active Wearable Compression System
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Koya Medical, Inc.
Triple Negative Breast Cancer
Phase I/II, Evaluate the Safety and Efficacy of BLEX 404 With Docetaxel in Patients With Advanced/Metastatic Triple Negative Breast Cancer.
The primary purpose of this study is to determine the safety and recommended dose level (RDL) of BLEX 404 Oral Liquid combined with Docetaxel monotherapy in a 21-day schedule.
- Trial name
- NCT02802423
- Testing
- BLEX 404 Oral Liquid
- Volunteers
- 44 people
- Sponsor
- BioLite, Inc.
Breast Cancer Surgery
Evaluation of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment
The aim of this exploratory study is to assess the performance and tolerability of the MOBIDERM Intimate Bra in the management of breast edema related to breast cancer treatment.
- Trial name
- MOBIBRA (NCT06303154)
- Testing
- Mobiderm Intimate Bra group
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Thuasne
Breast Cancer
Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative…
- Trial name
- monarchE (NCT03155997)
- Testing
- Abemaciclib, Standard Adjuvant Endocrine Therapy
- Where
- 619 sites in United States, Argentina and 36 more
- Volunteers
- 5,637 people
- Sponsor
- Eli Lilly and Company
Breast Fibroadenoma
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)
This is a multi-center, crossover study with cluster randomization and a planned accrual of 300 patients with diagnosed breast fibroadenoma (One fibroadenoma treated per patient).
- Trial name
- NCT03742401
- Testing
- Surgery, HIFU (Echopulse)
- Where
- 12 sites in France
- Volunteers
- 2 people
- Sponsor
- Theraclion
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
Breast Cancer, Melanoma
Trial of Lymphoseek in Intraoperative Localization of Lymph Nodes in Breast Cancer and Melanoma
Data from this pivotal clinical trial will be used to support a marketing application (i.e., NDA) for Navidea's Lymphoseek for use in intraoperative localization of lymph tissue (nodes) in the lymphatic pathway draining the…
- Trial name
- NCT00671918
- Testing
- Lymphoseek
- Where
- 15 sites in United States, Israel
- Volunteers
- 186 people
- Sponsor
- Navidea Biopharmaceuticals
Breast Cancer
Study the Role of Positron Emission Mammography in Pre-surgical Planning for Breast Cancer
Women with newly diagnosed breast cancer anticipating breast-conserving surgery are enrolled into the study and will undergo both high-resolution positron emission mammographic (PEM) imaging and contrast-enhanced magnetic…
- Trial name
- NCT00484614
- Testing
- Positron Emission Mammography, Magnetic Resonance Imaging
- Where
- 6 sites in United States
- Volunteers
- 472 people
- Sponsor
- Naviscan PET Systems
Breast Cancer
Safety and Efficacy of Hormone Therapy With Letrozole in Postmenopausal Women With Breast Cancer
The aim of this study is to assess the safety and efficacy of neoadjuvant hormone therapy with letrozole in postmenopausal women with estrogen- and/or progesterone-receptor positive primary breast cancer on tumour regression to…
- Trial name
- NCT00330317
- Testing
- letrozole
- Where
- 20 sites in United Kingdom
- Volunteers
- 300 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility (IMPACT) Registry
This is a minimal risk post-market registry study conducted at participating clinical institutions that are utilizing LumiSystem consistent with the U.S.
- Trial name
- IMPACT (NCT07616856)
- Where
- 2 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Lumicell, Inc.
Breast Neoplasms, Breast Cancer
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Researchers are looking for new ways to treat triple-negative breast cancer (TNBC) and hormone receptor (HR) low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer.
- Trial name
- NCT06797635
- Testing
- Patritumab deruxtecan, Pembrolizumab, Paclitaxel
- Where
- 17 sites in United States, South Korea and 2 more
- Volunteers
- 372 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Breast Cancer
MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery
The purpose of this study is to show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision.
- Trial name
- Pivotal (NCT00749931)
- Testing
- MarginProbe, Lumpectomy
- Where
- 21 sites in United States, Israel
- Volunteers
- 664 people
- Sponsor
- Dune Medical Devices
Astrocytoma, Brain Cancer
Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S
This is a multi-center, open-label, dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and maximum tolerated dose (MTD) of QBS10072S in patients with advanced or metastatic cancers…
- Conditions
- Astrocytoma, Brain Cancer, Brain Metastases, Bladder Cancer
- Trial name
- NCT04430842
- Testing
- QBS10072S
- Where
- 2 sites in Australia
- Volunteers
- 15 people
- Sponsor
- Quadriga Biosciences, Inc.