Breast Cancer Female Clinical Trial
Official title:
Sentinel Node Biopsy and Targeted Axillary Dissection in Node-Positive Breast Cancer Patients With Clinically Negative Axilla
RATIONALE: It is now standard for most breast cancer patients with 1-2 positive sentinel nodes to avoid completion node dissection when eligibility criteria from the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial are met. The National Comprehensive Cancer Network (NCCN) recently proposed to extend this indication to patients that present with biopsy proven node positive disease if only 1 or 2 suspicious nodes are found on imaging, these positive nodes are not palpable clinically, and the other eligibility criteria from the Z0011 study are otherwise met. However, this recommendation is based on an expert consensus and no study has yet confirmed the optimal method to stage the axilla in this patient population. PURPOSE: Evaluate the technical success rate and accuracy of sentinel node biopsy (SNB) and the potential benefits of clipping and removing the biopsy proven node using radioactive seed localisation (RSL) (SNB+RSL = Targeted Axillary Dissection (TAD)) in patients with biopsy proven positive nodes, limited nodal disease in imaging and clinically negative axillary examination.
This is a prospective multicenter study. Patients with T1-2 Breast cancer and clinically negative axilla on palpation, 1-2 suspicious nodes on ultrasound, and a biopsy proven positive node (by core biopsy of fine needle aspiration) will have a radioactive seed (I125) placed in their clipped node before surgery. At the time of surgery, patients that are scheduled for breast conserving surgery or mastectomy will have sentinel node biopsy (SNB) using radioactive dye (Tc99) +/- blue dye as well as retrieval of the clipped node using radioactive seed localisation (RSL). Removal of the I125 radioactive seed in the clipped node will be performed before the Tc99 counts are performed to prevent "shine through" and biased measurements. Imaging of the surgical specimen will confirm retrieval of the clipped node. Prospectively recorded information on pre-operative axillary imaging, characteristics of the retrieved nodes in the operating room and detailed pathological analysis of each corresponding node will be performed. Completion node dissection (CND) is not mandatory in this study but recommended if the clipped positive node is not retrieved, if 4 nodes or more are positive or if 3 nodes are positive in the absence of axillary radiation. The benefits of adding RSL to SNB and the benefits of adding SNB to RSL staging of the axilla will be evaluated in this study and will help to better define the value of using TAD in this patient population. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03080623 -
Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion
|
||
| Completed |
NCT05527769 -
Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique
|
||
| Completed |
NCT06376578 -
Exercise Interventions for Improving Health in Breast Cancer Survivors
|
N/A | |
| Completed |
NCT03004534 -
A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide
|
Early Phase 1 | |
| Recruiting |
NCT05020574 -
Microbiome and Association With Implant Infections
|
Phase 2 | |
| Active, not recruiting |
NCT06277141 -
The Vitality Mammography Messaging Study
|
N/A | |
| Completed |
NCT03270111 -
High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women
|
N/A | |
| Completed |
NCT03555227 -
USG PECS vs LIA for Breast Cancer Surgery
|
N/A | |
| Active, not recruiting |
NCT03917082 -
Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT05561842 -
Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria (Mobile Health: Technology and Outcomes in Low and Middle-Income Countries)
|
||
| Completed |
NCT04554056 -
Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT03127995 -
Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence
|
N/A | |
| Active, not recruiting |
NCT02237469 -
Prone Breast Radiotherapy Treatment Planning Observational Study
|
||
| Completed |
NCT01204125 -
Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients
|
Phase 2 | |
| Recruiting |
NCT04565054 -
Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC
|
Phase 3 | |
| Not yet recruiting |
NCT06412133 -
Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients
|
N/A | |
| Recruiting |
NCT03956641 -
Evolution of the Physical Condition in Treated Cancer Patients
|
N/A | |
| Recruiting |
NCT06087120 -
Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
|
||
| Recruiting |
NCT06058936 -
Exercises Using Virtual Reality on Cancer Patients
|
N/A | |
| Completed |
NCT03470935 -
Non-interventional Study Evaluating Gynecological Impact of Diagnosis and Treatment of Breast Cancer in Patients Younger
|