Clinical trials: Breast Surgery
Breast Cancer
Surgical Site Infection With 0.05% Chlorhexidine (CHG) Compared to Triple Antibiotic Irrigation
The investigators intend to perform a prospective randomized study and compare the incidence of surgical wound infection between mastectomy wounds irrigated with triple antibiotic solution (one side) and 0.05% CHG (opposite side)…
- Trial name
- NCT02395614
- Testing
- Chlorhexidine irrigation, triple antibiotic irrigation
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- Vanderbilt University Medical Center
Breast Cancer
Targeted T Cells After Neoadjuvant Chemotherapy in Treating Women With Stage II or III Breast Cancer Undergoing Surgery
RATIONALE: Neoadjuvant chemotherapy for women with stage II-III Her negative breast cancer followed by Her2Bi armed activated T cells (ATCs) may significantly improve the pathologic complete response (pCR) rate at the time of…
- Trial name
- NCT01147016
- Testing
- HER2Bi-armed activated T cells, cyclophosphamide, doxorubicin hydrochloride
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Barbara Ann Karmanos Cancer Institute
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
Stage IIA Breast Cancer, Stage IIB Breast Cancer
Chemotherapy Before Surgery and Tissue Sample Collection in Patients With Stage IIA-IIIC Breast Cancer
This pilot clinical trial studies chemotherapy before surgery and tissue sample collection in patients with stage IIA-IIIC breast cancer.
- Conditions
- Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer
- Trial name
- NCT01897441
- Testing
- Cyclophosphamide, Cytology Specimen Collection Procedure, Doxorubicin Hydrochloride
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Albert Einstein College of Medicine
Breast Adenocarcinoma, Hormone Receptor Positive
Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)
This randomized phase III trial studies the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone…
- Conditions
- Breast Adenocarcinoma, Hormone Receptor Positive, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7
- Trial name
- TAILORx (NCT00310180)
- Testing
- Anastrozole, Exemestane, Laboratory Biomarker Analysis
- Where
- 1,222 sites in United States, Australia and 6 more
- Volunteers
- 10,273 people
- Sponsor
- National Cancer Institute (NCI)
Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8, Metastatic Breast Carcinoma
Testing Whether Treating Breast Cancer Metastases With Surgery or High-Dose Radiation Improves Survival
This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has…
- Conditions
- Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Neoplasm in the Liver
- Trial name
- NCT02364557
- Testing
- Stereotactic Body Radiotherapy, Surgery
- Where
- 162 sites in United States, Canada and 2 more
- Volunteers
- 129 people
- Sponsor
- NRG Oncology
Breast Cancer
Radiation Therapy During Surgery in Treating Older Women With Invasive Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation during surgery may be an effective treatment for breast cancer.
- Trial name
- NRR (NCT00182728)
- Testing
- surgery, therapy, radiation therapy
- Where
- United States
- Volunteers
- 89 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Breast Cancer
Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer
RATIONALE: Removing the sentinel lymph nodes and examining them under a microscope may help plan more effective surgery for breast cancer.
- Trial name
- NCT00003830
- Testing
- conventional surgery, Sentinel node resection followed by node examination
- Where
- 78 sites in United States, Canada and 1 more
- Volunteers
- 5,611 people
- Sponsor
- NSABP Foundation Inc
Breast Cancer, Anxiety
Self Hypnotic Relaxation As An Adjunct To Local Anesthesia During Large Core Breast Biopsy
Percutaneous large core image-guided breast biopsy is a well established tool in diagnosing breast cancer, but the associated anxiety and pain can tax the coping mechanism of even well functioning individuals.
- Conditions
- Breast Cancer, Anxiety, Pain
- Trial name
- NCT00122369
- Testing
- Self-hypnotic Relaxation, Empathic Attention
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Beth Israel Deaconess Medical Center
Hyperplasia
Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery
Purpose: The aims of this randomized clinical trial are to assess and compare 3 different outcomes in women undergoing breast reduction surgery using two different surgical devices: the Harmonic Scalpel and electrocautery.
- Trial name
- NCT00819260
- Testing
- Harmonic Scalpel, Electrocautery
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Hematoma Postoperative
A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery
This trial is being completed to evaluate the safety and efficacy of topical tranexamic acid use in preventing hematomas in routine breast plastic surgery operations.
- Trial name
- NCT05441592
- Testing
- Tranexamic acid injection, No additional irrigation
- Where
- United States
- Volunteers
- 107 people
- Sponsor
- University of Michigan
Breast Cancer
PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Lumpectomy
The purpose of this clinical study is to quantify the difference in thermal injury depth at the surgical margin in breast lumpectomy specimens excised with the PlasmaBlade; to subjectively assess histopathologic sample quality…
- Trial name
- PRECISE (NCT00960154)
- Testing
- PEAK PlasmaBlade, Traditional Electrosurgery with scalpel
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic Surgical Technologies
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
Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before.
- Trial name
- NCT03734029
- Testing
- Trastuzumab deruxtecan (DS-8201a), Capecitabine, Eribulin
- Where
- 208 sites in United States, Austria and 18 more
- Volunteers
- 557 people
- Sponsor
- Daiichi Sankyo
Hypomastia, Primary Breast Augmentation
3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery
The purpose of this trial is to evaluate the impact of incorporating three-dimensional (3D)imaging during preoperative consultation on patient reported outcomes in primary breast augmentation surgery.
- Trial name
- NCT01964105
- Testing
- 3D Imaging
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Washington University School of Medicine
Gynecomastia
Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery
This is a prospective, multi-center, single-blinded, randomized study of up to 10 study subjects undergoing bilateral gynecomastia surgery with Renuvion APR System used as an adjunct procedure on one side.
- Trial name
- NCT05093049
- Testing
- Renuvion APR System, Gynecomastia Correction Surgery
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Apyx Medical
Macromastia
A Study to Evaluate Cutaneous Scar Quality Following Bilateral Breast Reduction With the PEAK PlasmaBlade 4.0
The objective of this clinical study is to evaluate scar quality following incision with the PEAK PlasmaBlade 4.0 using the Patient and Observer Scar Assessment Scale (POSAS), and to compare these results to equivalently-aged…
- Trial name
- PRECISE (NCT01284491)
- Testing
- PEAK PlasmaBlade 4.0, Traditional Electrosurgery with scalpel
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Medtronic Surgical Technologies
Triple Negative Breast Cancer, Breast Cancer
Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer
The purpose of this study is to evaluate the mechanism of action, as well as the safety and efficacy of trilaciclib in combination with standard of care treatment in the neoadjuvant setting of early-stage triple negative breast…
- Trial name
- NCT05112536
- Testing
- Trilaciclib, Cylophosphamide, Doxorubicin
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- G1 Therapeutics, Inc.
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.
Patient and Surgical Related Risk Factors for Complications
TiLoop® Bra for Breast Reconstruction
A new approach for single stage implant based breast reconstruction (BR) is the use of a titanium-coated polypropylene mesh (TCPM) as an alternative to acellular dermal matrix (ADM).
- Trial name
- NCT01544023
- Volunteers
- 207 people
- Sponsor
- University of Rostock