Breast Cancer Clinical Trial
Official title:
Preoperative and Intraoperative Quantification of Axillary Tumoral Load to Reduce the Need of Axillary Lymph Node Dissection in Breast Cancer Patients With Positive Lymph-nodes at Diagnosis
At present, patients diagnosed of a breast cancer with infiltration of the axillary
lymph-nodes are submitted to axillary lymph-node dissection (ALND). The sentinel node (SN)
technique is not indicated when a lymph-node biopsy or cytology is positive, nor when the
surgical treatment is upfront neither when a neoadjuvant systemic therapy is indicated. The
reason for not performing SN is that patients diagnosed of an infiltrated axilla though
ultrasound-guided biopsy or cytology tend to have a higher tumoral load than those diagnosed
after a sentinel biopsy. Furthermore, even if these patients are submitted to a neoadjuvant
systemic treatment and the axillary clinical exploration is negative after the treatment,
different studies showed that the SN false negative rate is unacceptably high.
Despite these facts, a high proportion of patients with a positive axilla at diagnosis and
submitted to level I and II axillary lymph node dissection show few lymph nodes infiltrated
in the pathological study, frequently four or less neoplastic nodes. New methods of
detecting these patients with limited infiltrated nodes should be developed and new
approaches to axillary surgery (i.e., partial resection) should be offered.
To date, the only information expected to get after an axillary imaging is performed is if
the axilla is infiltrated or not. No information about the tumoral load is demanded. In the
other hand, level I and II ALND is performed according to established anatomic limits,
without selecting the nodes to be excised neither identifying the ones infiltrated for a
directed excision.
The aim of the study is to evaluate the ability of a specified and reproducible imaging
protocol for distinguishing patients with a high axillary tumoral load from the ones with a
low tumoral load. At the same time, as the initial nodes receiving lymph drainage should be
the ones commonly affected, identifying these nodes injecting diluted methylene blue in the
retroareolar parenchyma and studying their tumoral load could help selecting patients with
high from those with low axillary tumoral load.
Evaluation of both steps (that is, first the imaging protocol followed by the methylene blue
protocol), could eventually help to distinguish which patients should be submitted to a
classical level I and II ALND and which ones can be spared from excising the lymph nodes not
stained by the methylene blue.
n/a
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
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
|
||
Recruiting |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
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 |
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 | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |