Breast Cancer Clinical Trial
— SP NSMOfficial title:
A Prospective, Multicenter Randomized Controlled Trial(RCT) of the da Vinci® SP™ Surgical System vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures
This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
| Status | Recruiting |
| Enrollment | 204 |
| Est. completion date | December 2026 |
| Est. primary completion date | December 2025 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 21 Years and older |
| Eligibility | Inclusion Criteria: - Female age 21 or older - BMI < 30 - Candidate for an NSM procedure with immediate reconstruction - Diagnosis of early stage brest cancer - Breast ptosis = Grade 2. - Cup size = C. Exclusion Criteria: - Previous breast surgery - Diagnosis of metastatic breast cancer - Prior radiation treatment to the chest - Current smokers - Contraindication for general anesthesia or surgery. - Known bleeding or clotting disorder. - Pregnant or suspected to be pregnant, or actively breastfeeding |
| Country | Name | City | State |
|---|---|---|---|
| United States | Emory University | Atlanta | Georgia |
| United States | Corewell | Detroit | Michigan |
| United States | City of Hope | Duarte | California |
| United States | Duke University | Durham | North Carolina |
| United States | NorthShore University HealthSystem | Evanston | Illinois |
| United States | MD Anderson Cancer Center | Houston | Texas |
| United States | Mayo Clinic Florida | Jacksonville | Florida |
| United States | Northwell Health | Lake Success | New York |
| United States | Cedars-Sinai | Los Angeles | California |
| United States | Ascension St. Columbia Mary's | Milwaukee | Wisconsin |
| United States | Vanderbilt | Nashville | Tennessee |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Mayo Clinic Rochester | Rochester | Minnesota |
| United States | Washington University, St. Louis | Saint Louis | Missouri |
| United States | University of Washington | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Intuitive Surgical |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Conversion rate | Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery | Assessed during procedure | |
| Primary | Safety: Adverse event rates | Incidence of intraoperative and post-operative procedure and device-related adverse events compared to open NSM | Up to 42 days post-operatively | |
| Primary | Safety: positive surgical margin rates | Incidence of positive surgical margins compared to open NSM | Up to 42 days post-operatively | |
| Secondary | Oncological Outcomes (for cancer recurrence) | Recurrence | Up to 5 years | |
| Secondary | Oncological Outcomes (for disease-free survival) | Disease-free survival | Up to 5 years | |
| Secondary | Oncological Outcomes (for overall survival) | Overall survival | Up to 5 years | |
| Secondary | Patient-Report Outcomes (BREAST-Q) | BREAST-Q | Up to 5 years | |
| Secondary | Patient-Report Outcomes (NAC Questionnaire) | NAC Questionnaire | Up to 5 years | |
| Secondary | Patient-Report Outcomes (EQ-5D) | EQ-5D | Up to 1 year |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
| Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
| Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
| Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
| Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
| Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
| Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
| Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
| Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
| Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
| Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
| Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
| Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
| Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
| Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
| Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
| Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
| Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A |