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Refining Local-Regional Therapy for IBC

Primary Purpose

Breast Cancer, Inflammatory Breast Cancer, Sentinel Lymph Node

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lymphoscintigraphy
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer, Inflammatory Breast Cancer, Sentinel Lymph Node

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Stage III IBC (cT4d cN0-2). Inflammatory breast cancer is defined as the following constellation of symptoms (all of the following must be met):

    • Rapid onset symptoms (6 months or less from time of diagnosis)
    • Breast erythema, edema and/or peau d'orange and/or warm breast with or without an underlying palpable mass
    • Erythema occupying at least one-third of the breast
    • Pathologic confirmation (biopsy-proven) invasive breast carcinoma
  • Women age ≥18 years
  • ECOG performance status ≤2
  • Ability to understand and willingness to sign informed consent document and comply with study procedures, including baseline research biopsy. If the research biopsy is not felt to be reasonably safe or feasible, a waiver must be obtained from the Principal Investigator. A formal exception would not be required in this case.

Exclusion Criteria:

  • Participants who initiated pre-operative/neoadjuvant therapy prior to registration are ineligible.
  • Participants with Stage IV (metastatic) breast cancer are excluded. The absence of any evidence of distant disease on staging studies needs to be confirmed at the time of diagnosis (within 42 days from initial presentation) using the staging studies that are standard for the participating institution.
  • Participants with positive contralateral axillary nodes identified on standard imaging studies (MMG, MRI, US) are excluded. In participants with clinically suspicious axillary nodes, US guided biopsy will be performed prior to registration. If the contralateral axillary biopsy is positive, patients will not be eligible. If standard imaging does not identify contralateral disease yet drainage to the contralateral axillary basin is identified on pre-NAC lymphoscintigraphy, contralateral axillary US (if not already performed) will be obtained and any suspicious contralateral axillary nodes will undergo US guided biopsy. If the contralateral axillary biopsy is positive, patients will not continue on study for the evaluation of the primary endpoint, but their data will be used for the descriptive analyses of lymphatic drainage patterns in IBC. Contralateral invasive breast cancer without axillary involvement or in-situ carcinoma in either breast is allowed.

Sites / Locations

  • Dana Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sentinal Node Identification

Arm Description

Within standard of care treatment for inflammatory breast cancer, participants will undergo a series of Lymphoscintigraphies: an imaging procedure to determine where their lymphatic system drains from their breast. Prior to neoadjuvant chemotherapy Day before surgery These two imaging studies will be compared and the information used during participant's surgery to perform the sentinel node biopsy procedure. During surgery participants will have a blue dye injected to affected breast to map drainage and identify sentinal nodes. The sentinal nodes will be removed first, followed by standard of care procedure to remove all axillary lymph nodes. After surgery, a small amount of tissue from the tumor removed during surgery will be evaluated. Participants will complete a Lymphedema Questionnaire after each Lymphoscintigraphy then every 6 months for 2 years post surgery.

Outcomes

Primary Outcome Measures

Sentinel Lymph Node (SLN) identification rate
The identification rate will be calculated as a ratio of the number of patients in whom SLN(s) were successfully identified over the total number of patients in whom SLN mapping was attempted.

Secondary Outcome Measures

Prevalence of lymphedema
Assess the prevalence of lymphedema following comprehensive local therapy (surgery + regional RT) using the patient-reported Lymphedema Symptom Intensity and Distress Survey - Arm (LSIDS-A) (Appendix A).
Local-regional recurrence free survival rate (LRRFS)
Duration of time from surgery until invasive ipsilateral local-regional recurrence or death from any cause; in the absence of an event, LRRFS will be censored at the date last know alive and free from local regional recurrence (LRR).
Distant recurrence-free survival rate (DRFS)
Duration of time from surgery until distant recurrence or death from any cause; in the absence of an event, DRFS will be censored at the date last know alive and free from distant recurrence
Disease-free survival (DFS)
Duration of time from surgery until invasive ipsilateral local regional recurrence, invasive contralateral breast cancer, distant recurrence, or death from any cause; in the absence of an event, DFS will be censored at the date last know alive and free from all events.

Full Information

First Posted
November 13, 2020
Last Updated
July 10, 2023
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04636710
Brief Title
Refining Local-Regional Therapy for IBC
Official Title
Refining Local-Regional Therapy for Inflammatory Breast Cancer (IBC)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This Feasibility study is trying to determine: If Lymphoscintigraphy (imaging of the lymphatic drainage patterns) is effective in demonstrating the drainage to the sentinel lymph nodes in patients with inflammatory breast cancer. The likelihood of identifying the sentinel lymph nodes in the operating room, using both blue dye and the radioactive substance used for lymphoscintigraphy. The incidence of lymphedema (arm swelling which occurs after lymph node surgery) in women with inflammatory breast cancer Outcomes for women with inflammatory breast cancer, whether or not the sentinel lymph nodes can be identified.
Detailed Description
This research study is a Feasibility Study, which means the investigators are collecting information from a relatively small group of patients to determine if the sentinel lymph node procedure identifies the first nodes that drain the breast in patients with inflammatory breast cancer. The sentinel node procedure is a standard method to evaluate whether breast cancer has spread to the axillary lymph nodes (lymph nodes under the arm) or remains in the lymph nodes under the arm after chemotherapy in non-inflammatory breast cancer. "Standard" means that sentinel lymph node biopsy is accepted by the majority of the medical community as a suitable method to determine if breast cancer has spread to the lymph nodes or remains in the lymph nodes after chemotherapy. In women with non-inflammatory breast cancer, these lymph nodes are tested first and if they are free of cancer additional lymph nodes are not removed. By safely limiting the amount of lymph node surgery to only the sentinel lymph nodes, the likelihood of developing lymphedema (arm swelling after lymph node surgery) has declined among women with non-inflammatory breast cancer. Currently, sentinel lymph node biopsy is not performed in inflammatory breast cancer as there are little data supporting that it works or is accurate. For inflammatory breast cancer, performing lymphoscintigraphy (imaging study to show the drainage from the breast to the lymph nodes) and sentinel lymph node biopsy is investigational. "Investigational" means that this is being studied. If in this study it is determined that sentinel lymph nodes can be accurately identified and tested in patients with inflammatory breast cancer, this could lead to future studies testing whether complete lymph node dissection can be avoided in women with inflammatory breast cancer whose sentinel nodes are free of cancer. Thus, potentially also reducing the likelihood of lymphedema in patients who receive treatment for inflammatory breast cancer. The research study procedures include screening for eligibility, imaging evaluation, lymphoscintigraphy, sentinel lymph node evaluation, a mandatory research biopsy, research blood draws and questionnaires. It is expected that about 50 people will take part in this research study at participating sites around the United States Johns Hopkins University on behalf of the Translational Breast Cancer Research Consortium (TBCRC) is supporting this research study by providing funding for the research study. The TBCRC is a group of academic medical centers across the United States that work together to conduct breast cancer research.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Inflammatory Breast Cancer, Sentinel Lymph Node
Keywords
Breast Cancer, Inflammatory Breast Cancer, Sentinel Lymph Node

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sentinal Node Identification
Arm Type
Experimental
Arm Description
Within standard of care treatment for inflammatory breast cancer, participants will undergo a series of Lymphoscintigraphies: an imaging procedure to determine where their lymphatic system drains from their breast. Prior to neoadjuvant chemotherapy Day before surgery These two imaging studies will be compared and the information used during participant's surgery to perform the sentinel node biopsy procedure. During surgery participants will have a blue dye injected to affected breast to map drainage and identify sentinal nodes. The sentinal nodes will be removed first, followed by standard of care procedure to remove all axillary lymph nodes. After surgery, a small amount of tissue from the tumor removed during surgery will be evaluated. Participants will complete a Lymphedema Questionnaire after each Lymphoscintigraphy then every 6 months for 2 years post surgery.
Intervention Type
Procedure
Intervention Name(s)
Lymphoscintigraphy
Other Intervention Name(s)
Sentinel lymph node mapping
Intervention Description
An imaging procedure using an injected radioactive substance or dye to identify lymph drainage A doctor reviews the images to identify the sentinel lymph nodes based on where the dye goes to first.
Primary Outcome Measure Information:
Title
Sentinel Lymph Node (SLN) identification rate
Description
The identification rate will be calculated as a ratio of the number of patients in whom SLN(s) were successfully identified over the total number of patients in whom SLN mapping was attempted.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Prevalence of lymphedema
Description
Assess the prevalence of lymphedema following comprehensive local therapy (surgery + regional RT) using the patient-reported Lymphedema Symptom Intensity and Distress Survey - Arm (LSIDS-A) (Appendix A).
Time Frame
Every 6 months post surgery up to 2 years
Title
Local-regional recurrence free survival rate (LRRFS)
Description
Duration of time from surgery until invasive ipsilateral local-regional recurrence or death from any cause; in the absence of an event, LRRFS will be censored at the date last know alive and free from local regional recurrence (LRR).
Time Frame
Within 2 years from surgery
Title
Distant recurrence-free survival rate (DRFS)
Description
Duration of time from surgery until distant recurrence or death from any cause; in the absence of an event, DRFS will be censored at the date last know alive and free from distant recurrence
Time Frame
Within 2 years from surgery
Title
Disease-free survival (DFS)
Description
Duration of time from surgery until invasive ipsilateral local regional recurrence, invasive contralateral breast cancer, distant recurrence, or death from any cause; in the absence of an event, DFS will be censored at the date last know alive and free from all events.
Time Frame
Within 2 yhears from surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stage III IBC (cT4d cN0-2). Inflammatory breast cancer is defined as the following constellation of symptoms (all of the following must be met): Rapid onset symptoms (6 months or less from time of diagnosis) Breast erythema, edema and/or peau d'orange and/or warm breast with or without an underlying palpable mass Erythema occupying at least one-third of the breast Pathologic confirmation (biopsy-proven) invasive breast carcinoma Women age ≥18 years ECOG performance status ≤2 Ability to understand and willingness to sign informed consent document and comply with study procedures, including baseline research biopsy. If the research biopsy is not felt to be reasonably safe or feasible, a waiver must be obtained from the Principal Investigator. A formal exception would not be required in this case. Exclusion Criteria: Participants who initiated pre-operative/neoadjuvant therapy prior to registration are ineligible. Participants with Stage IV (metastatic) breast cancer are excluded. The absence of any evidence of distant disease on staging studies needs to be confirmed at the time of diagnosis (within 42 days from initial presentation) using the staging studies that are standard for the participating institution. Participants with positive contralateral axillary nodes identified on standard imaging studies (MMG, MRI, US) are excluded. In participants with clinically suspicious axillary nodes, US guided biopsy will be performed prior to registration. If the contralateral axillary biopsy is positive, patients will not be eligible. If standard imaging does not identify contralateral disease yet drainage to the contralateral axillary basin is identified on pre-NAC lymphoscintigraphy, contralateral axillary US (if not already performed) will be obtained and any suspicious contralateral axillary nodes will undergo US guided biopsy. If the contralateral axillary biopsy is positive, patients will not continue on study for the evaluation of the primary endpoint, but their data will be used for the descriptive analyses of lymphatic drainage patterns in IBC. Contralateral invasive breast cancer without axillary involvement or in-situ carcinoma in either breast is allowed.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Faina Nahklis, MD
Phone
617-632-3891
Email
fnakhlis1@bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faina Nahklis, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faina Nakhlis, MD
Phone
617-983-7777
Email
fnakhlis@partners.org
First Name & Middle Initial & Last Name & Degree
Faina Nakhlis, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

Refining Local-Regional Therapy for IBC

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