Predict the Risk of Axillary Metastases in Breast Cancer Patients With Axillary Ultrasound

Breast Cancer Female Clinical Trial

Official title:

A Nomogram to Predict the Risk of Axillary Metastases in Breast Cancer Patients With Axillary Ultrasound

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02992769
• Other study ID #: 201653
• Status: Recruiting
• Phase: N/A
• First received: December 11, 2016
• Last updated: December 15, 2016
• Start date: March 2016
• Est. completion date: September 2017

Study information

• Verified date: December 2016
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Jianguo Lai, M.D.
• Phone: 0086-15622172952
• Email: clarkdawson0210[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Axillary lymph node status is a vital prognostic factors in breast cancer patients and provides crucial information for making treatment decisions.This projective observational study is planned to identify risk factors for axillary metastases in breast cancer patients with axillary ultrasound and to construct a nomogram to predict the risk of axillary metastases in these patients.

Description:

Breast carcinoma is the most common malignancy in women, accounting for 25% of all female cancer cases and 15% of all cancer-related deaths in the world.Lymph node metastasis is a multifactorial event. Among patients with a preoperative axillary ultrasound, almost 40% of patients are pathologically proved to be free from axillary metastasis.The purpose of this study is to develop a nomogram to evaluate the probability of axillary metastasis as a tool to support clinical decision-making.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• female patients with primary breast cancer

• receiving a successful SLNB or ALND

• pathological diagnosed, without distant metastasis

• a clinically negative axilla

Exclusion Criteria:

• pregnancy

• neoadjuvant therapy

• previous ipsilateral axillary surgery

• inflammatory breast cancer

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Neoplasm Metastasis

Locations

Country	Name	City	State
China	Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (5)

Bevilacqua JL, Kattan MW, Fey JV, Cody HS 3rd, Borgen PI, Van Zee KJ. Doctor, what are my chances of having a positive sentinel node? A validated nomogram for risk estimation. J Clin Oncol. 2007 Aug 20;25(24):3670-9. — View Citation

Gentilini O, Veronesi U. Abandoning sentinel lymph node biopsy in early breast cancer? A new trial in progress at the European Institute of Oncology of Milan (SOUND: Sentinel node vs Observation after axillary UltraSouND). Breast. 2012 Oct;21(5):678-81. doi: 10.1016/j.breast.2012.06.013. — View Citation

Lyman GH, Temin S, Edge SB, Newman LA, Turner RR, Weaver DL, Benson AB 3rd, Bosserman LD, Burstein HJ, Cody H 3rd, Hayman J, Perkins CL, Podoloff DA, Giuliano AE; American Society of Clinical Oncology Clinical Practice.. Sentinel lymph node biopsy for patients with early-stage breast cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2014 May 1;32(13):1365-83. doi: 10.1200/JCO.2013.54.1177. — View Citation

Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. — View Citation

Tucker NS, Cyr AE, Ademuyiwa FO, Tabchy A, George K, Sharma PK, Jin LX, Sanati S, Aft R, Gao F, Margenthaler JA, Gillanders WE. Axillary Ultrasound Accurately Excludes Clinically Significant Lymph Node Disease in Patients With Early Stage Breast Cancer. Ann Surg. 2016 Dec;264(6):1098-1102. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axillary Metastases	Surgical treatment for breast cancer patients include breast-conserving surgery or mastectomy with or without breast reconstruction. Intraoperative ALND is carried out when the SLNs are positive by intraoperative frozen section. Post-operative H&E permanent staining is administered to confirm the results of the frozen section. Serial H&E and immunohistochemistry stain (IHC) are only carried out when axillary metastases are not visible after H&E staining.	4 months to 1.5 year	No