Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06329089
Other study ID # HCB/2023/0840
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date December 31, 2025

Study information

Verified date March 2024
Source Hospital Clinic of Barcelona
Contact Ines Torras, MD
Phone 93 227 54 00
Email itorras@clinic.cat
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to assess the effectiveness of sentinel lymph node biopsy as a treatment approach for patients with recurrent breast cancer on the same side as previous surgeries. The main questions it aims to answer are: - What is the rate of identification of the sentinel lymph node, and how does it vary among patients with different histories of axillary surgeries? - How can we describe and understand the drainage pathways, including those from the armpit on the same side as the cancer, the area near the breastbone, and the opposite armpit? Participants will undergo sentinel lymph node biopsy as part of their treatment for recurrent breast cancer. They will also receive standard treatments, including surgery and adjuvant therapies as recommended by their healthcare team.


Description:

Prospective multicentric collection will be conducted for all patients diagnosed with ipsilateral recurrent breast cancer, who meet the criteria and are eligible for surgery, and who wish to participate in the study. Additional examinations and treatments will be performed according to standard clinical practice. Tests not included in routine practice will not be conducted. Suspicion of axillary involvement will be ruled out using ultrasound or magnetic resonance imaging, as well as distant metastasis with standard staging studies (bone scintigraphy/computed tomography of the thorax, abdomen, and pelvis). Lymphatic mapping will be performed according to each hospital's protocol, similar to lymphatic mapping in primary breast cancer. The radiotracer/dye will be injected according to each center's standard practice (peritumoral, intratumoral, intradermal, or periareolar in the quadrant of the tumor) the day before or on the day of surgery by Nuclear Medicine/Radiology. Lymphoscintigraphy will be performed, and the detected sentinel lymph nodes (SLNs) will be marked on the skin with ink/marker. In cases where the SLN is not visualized, a second dose of radiotracer may be administered. If there is no drainage from the SLN and no prior lymphadenectomy (LA), additional axillary surgery will not be performed. If there is no drainage from the SLN and no prior LA, consideration will be given to performing lymphadenectomy according to each center's protocol. During surgery, SLNs will be identified using a gamma probe and/or dye, with assistance from the nuclear medicine service. Between one and three SLNs will be removed (whether drainage is in the ipsilateral axilla, internal mammary, or contralateral axilla). They will be sent to Pathology for intraoperative or deferred examination (by One-Step Nucleic Acid Amplification (OSNA) or conventional technique). If infiltration is found in any of the axillary SLNs (isolated tumor cells, micrometastasis, or macrometastasis), axillary surgery will be completed with a lymphadenectomy including levels I and II of Berg. If infiltration is found in internal mammary SLNs and not in axillary SLNs, irradiation of the internal mammary chain will be performed (recommended dose of 50 Gy), without completing the LA. If contralateral axillary SLNs are affected, further treatment will be decided by consensus in the subsequent treatment committee. A wound care visit with a specialized breast unit nurse will be scheduled for the week after surgery to assess postoperative complications, and an outpatient consultation with Gynecology will be scheduled for 3 weeks after surgery for further evaluation. Adjuvant treatment will be administered according to consensus in the hospital's multidisciplinary committee, following standard practice. Follow-up will be conducted in outpatient consultations with Gynecology/Medical Oncology/Radiation Oncology, with physical examination every 4-6 months, and annual mammography and ultrasound, as per the consensus of the hospital's breast unit. A validated Spanish-language quality of life questionnaire following breast surgery (BREAST-Q) will be administered by Gynecology at 12 months post-surgery, along with evaluation of late postoperative complications.


Recruitment information / eligibility

Status Recruiting
Enrollment 97
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Patients >18 years old with ipsilateral local recurrence of breast cancer with clinical stage cT1-3 cN0 confirmed by histology, with a history of previous axillary surgery (both sentinel lymph node biopsy and lymphadenectomy). Exclusion Criteria: - Patients with confirmed axillary metastasis (histology/immunohistochemistry) - Inflammatory carcinoma - Patients with suspected or confirmed distant metastasis on staging studies - Inability to perform the sentinel lymph node biopsy technique: allergy to radiotracer, mobility limitation

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Reoperative Sentinel Lymph Node Biopsy
Reoperative sentinel lymph node biopsy refers to a surgical procedure performed when there is a need to re-examine the sentinel lymph nodes (SLNs) in patients who have previously undergone breast cancer surgery. The sentinel lymph nodes are the first lymph nodes to which cancer cells are likely to spread from the primary tumor. During the procedure, the surgeon locates and removes the previously identified sentinel lymph nodes using techniques such as lymphatic mapping and injection of a radiotracer or dye. The removed lymph nodes are then examined by a pathologist to determine if there is any evidence of cancer spread.

Locations

Country Name City State
Spain Hospital Clínic de Barcelona Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Re-Sentinel Lymph node harvesting rate Calculation of SLN identification rate and analysis of subgroups based on previous axillary surgery. 12 months
Primary Drainage pathways description Describe and study the drainage pathways including the ipsilateral axilla, the internal mammary chain, and the contralateral axilla 12 months
Secondary Complications rate Analyze the surgical complications of the axillary, internal mammary, and contralateral axillary SLN technique in patients with previous axillary surgery. 12 months
Secondary Axillary metastasis rate Calculate the rate of axillary metastatic infiltration and lymphadenectomy in patients with ipsilateral recurrent breast cancer and axillary negative clinical stage (cN0) 12 months
Secondary Correlation Between Axillary and Internal Mammary Chain Infiltration Investigate the relationship between axillary and internal mammary chain infiltration 12 months
Secondary Quality of life in recurrent breast cancer Assess the quality of life in patients undergoing re-intervention for ipsilateral recurrent breast cancer using a validated questionnaire (Breast-Q). 12 months
See also
  Status Clinical Trial Phase
Completed NCT01987726 - Comprehensive Gene Sequencing in Guiding Treatment Recommendations Patients With Metastatic or Recurrent Solid Tumors
Completed NCT01881230 - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) Phase 2/Phase 3
Terminated NCT01918306 - GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer Phase 1/Phase 2
Terminated NCT01705340 - Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery Phase 1
Terminated NCT01222377 - Endoscopic Breast Surgery in Treating Patients With Breast Cancer N/A
Completed NCT00602043 - F-18 16 Alpha-Fluoroestradiol-Labeled Positron Emission Tomography in Predicting Response to First-Line Hormone Therapy in Patients With Stage IV Breast Cancer Phase 2
Completed NCT00244881 - A Phase II Study of AZD2171 in Breast Cancer Stage IV (10006202) Phase 2
Completed NCT00425672 - ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment Phase 1/Phase 2
Completed NCT00096109 - Tanespimycin in Treating Women With Refractory Locally Advanced or Metastatic Breast Cancer Phase 2
Completed NCT00096434 - Sorafenib in Treating Patients With Metastatic Breast Cancer Phase 2
Completed NCT00057941 - Anastrozole and ZD1839 Compared With Fulvestrant and ZD1839 in Postmenopausal Women w/ Metastatic Breast Cancer Phase 2
Completed NCT01147484 - A Study of Foretinib in Patients With Recurrent/Metastatic Breast Cancer Phase 2
Completed NCT02015559 - Mucoadhesive Oral Wound Rinse in Preventing and Treating Stomatitis in Patients With ER- or PR-Positive Metastatic or Locally Recurrent Breast Cancer That Cannot be Removed by Surgery Receiving Everolimus Phase 2
Completed NCT01478477 - Omega-3 Fatty Acids in Preventing Joint Symptoms in Patients With Stage I-III Breast Cancer Receiving Anastrozole, Exemestane, or Letrozole N/A
Completed NCT01672684 - Phase I: At-Home Support for Rural Women Using Group Video Calling Phase 1
Completed NCT01764789 - Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer N/A
Terminated NCT01217411 - RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer Phase 1
Terminated NCT01233505 - Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors Phase 1
Completed NCT01037790 - Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer Phase 2
Active, not recruiting NCT00791037 - Vaccine Therapy in Treating Patients With Stage IV Breast Cancer Phase 1/Phase 2