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Positive Node Traced Before Neoadjuvant Chemotherapy (NAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03355261
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Jianyi Li, Shengjing Hospital

Brief Summary:
To investigate this regression model by injecting and tracing carbon nanoparticles (CNs) into the fusion node prior to NAC in patients with breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: complete remission (CR) group Procedure: partial remission (PR) group Procedure: stable disease (SD) group Procedure: progressive disease (PD) group Not Applicable

Detailed Description:
Guided by ultrasound, 0.3 mL of CNs suspension was injected in a fusion node prior to NAC in 110 patients with local advanced breast cancer. Patients underwent breast surgery and total axillary lymph node dissection following 2-6 cycles of NAC. The distribution by intercostobrachial nerves (ICBN) of positive nodes, black-stained nodes and lymphovascular invasion was investigated by response to NAC.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Tracing for Axillary Lymph Nodes Dissection in the Patients With Fusion Lymph Node Before Neo-adjuvant Chemotherapy
Actual Study Start Date : July 1, 2014
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: complete remission (CR) group
According to the RECIST 1.1, 32 patients were allocated into the complete remission (CR) group based on their responses to neoadjuvant chemotherapy (NAC).
Procedure: complete remission (CR) group
According to the RECIST 1.1, 32 patients were allocated into the complete remission (CR) group based on their responses to neoadjuvant chemotherapy (NAC).

Experimental: partial remission (PR) group
According to the RECIST 1.1, 61 patients were allocated into the partial remission (PR) group based on their responses to neoadjuvant chemotherapy (NAC).
Procedure: partial remission (PR) group
According to the RECIST 1.1, 61 patients were allocated into the partial remission (PR) group based on their responses to neoadjuvant chemotherapy (NAC).

Experimental: stable disease (SD) group
According to the RECIST 1.1, 12 patients were allocated into the stable disease (SD) group based on their responses to neoadjuvant chemotherapy (NAC).
Procedure: stable disease (SD) group
According to the RECIST 1.1, 12 patients were allocated into the stable disease (SD) group based on their responses to neoadjuvant chemotherapy (NAC).

Experimental: progressive disease (PD) group
According to the RECIST 1.1, 5 patients were allocated into the progressive disease (PD) group based on their responses to neoadjuvant chemotherapy (NAC).
Procedure: progressive disease (PD) group
According to the RECIST 1.1, 5 patients were allocated into the progressive disease (PD) group based on their responses to neoadjuvant chemotherapy (NAC).




Primary Outcome Measures :
  1. The spatial distribution of positive nodes in axillary after neoadjuvant chemotherapy based on pectoralis minor location [ Time Frame: During the surgery ]
    After neoadjuvant chemotherapy, whether positive nodes remission (transform to negative), from Level III to Level II, and from Level II to Level I. This means that if the nodes at Level I are negative, the nodes at Level II or Level III will be negative; if the nodes at Level II are negative, the nodes at Level III will be negative; if the nodes at Level III are positive, the nodes at Level I and Level II will be positive.


Secondary Outcome Measures :
  1. The spatial distribution of black-stained in axillary after neoadjuvant chemotherapy based on pectoralis minor location [ Time Frame: During the surgery ]
    If the chemotherapy is sensitive, the number of black-stained nodes will increase from Level I, Level II, to Level III. If the chemotherapy is resistance, the number of black-stained nodes will remain the original number or a little increasing locally.

  2. The spatial distribution of positive nodes in axillary after neoadjuvant chemotherapy based on intercostobrachiales nerves (ICBN) location [ Time Frame: During the surgery ]
    After neoadjuvant chemotherapy, whether positive nodes remission (transform to negative), from above ICBN to below ICBN. This means that if the nodes below ICBN are negative, the nodes above ICBN will be negative; if the nodes above ICBN are positive, the nodes below ICBN will be positive.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • invasive ductal carcinoma diagnosed by biopsy;
  • clinically positive node diagnosed by contrast enhance computer tomography (CECT), the number of strengthened nodes at Level I ≥ 1 with the longest diameter of the strengthened node ≥ 2cm;
  • NAC regimen followed the NCCN guideline;
  • no prior history of breast cancer or other malignancies.

Exclusion Criteria:

  • the cycle number of neo-adjuvant chemotherapy is equal to or less than 2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355261


Locations
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China, Jilin
The Second Hospital of Jilin University
Changchun, Jilin, China
China, Liaoning
the First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
Sponsors and Collaborators
Shengjing Hospital
Investigators
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Principal Investigator: Jianyi Li, Master Shengjing Hospital
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Responsible Party: Jianyi Li, Principal Investigator, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT03355261    
Other Study ID Numbers: ShengjingH01
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No