Sentinel Lymph Node Biopsy in Clinically Node-negative Early Breast Cancer Patients After Neoadjuvant Chemotherapy

NCT03381092 | Unknown

• 1 other identifier: BCP21
• Study Type: observational
• Target: 348
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-center, non-randomized, non-controlled observational study.

Conditions

Invasive Breast Cancer

Keywords

neoadjuvant chemotherapy; sentinel lymph node biopsy; axillary lymph node dissection; Predictive model

Outcome Measures

Primary Outcomes (1)

• Positive Rate of Axillary Sentinel Lymph Nodes.

  Positive rate of axillary sentinel lymph nodes in patients with clinically node-negative early breast cancer after neoadjuvant chemotherapy will be assessed.

  Within 6 weeks after obtaining the post-surgery pathological results.

Secondary Outcomes (4)

• Detection Rate of Axillary Sentinel Lymph Nodes.

  Within 6 weeks after obtaining the post-surgery pathological results.

• Rate of Axillary Lymph Node Dissection.

  Within 6 weeks after obtaining the post-surgery pathological results.

• Proportion of Patients with Axillary Lymph Node Metastases.

  Within 6 weeks after obtaining the post-surgery pathological results.

• Axillary Lymph Nodes Status Prediction Model.

  Within 6 weeks after obtaining the post-surgery pathological results.

Study Arms (1)

invasive breast cancer

Patients with invasive breast cancer who have clinically negative axilla and receive neoadjuvant treatment followed by sentinel lymph node biopsy are eligible for this study.

Eligibility Criteria

• Age: Up to 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Invasive breast cancer patients with clinically negtive axilla.

You may qualify if:

• Invasive breast cancer diagnosed with core needle needle biopsy;
• Staging cT1b-2N0M0;
• ER/PR positive cells ratio \<10%, or HER2 positive (according to ASCO-CAP guidelines),and with chemotherapy indications;
• Without chemotherapy contraindications, and planned or has started neoadjuvant chemotherapy (HER2 positive breast cancer neoadjuvant anti-HER2 treatment, or have adjuvant anti-HER2 treatment plan);
• With axillary sentinel lymph node biopsy indications confirmed prior to neoadjuvant therapy;
• Voluntarily join the study and sign an informed consent form.

You may not qualify if:

• History of malignant tumors.
• With chemotherapy contraindications.
• Recieved any form of surgery of primary tumor or axillary lymph nodes.
• Refuse neoadjuvant chemotherapy.
• Refuse assessment examinations.
• Refuse to join the study.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Axillary lymph node status are determined in SLNB(sentinel lymph node biopsy) and surgical specimen

Study Officials

• Qi-jun Zheng, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qi-jun Zheng, MD

CONTACT

0086-10-88271119; 13466552347@139.com

Ying-jian He, MD

CONTACT

0086-10-88271119; mimi487@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Breast Center of Peking University Cancer Hospital

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 21, 2017
• Study Start: December 22, 2017
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 29, 2021

Record last verified: 2021-11

Locations

CN (1)