Refining Local-Regional Therapy for IBC
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ClinicalTrials.gov Identifier: NCT04636710 |
Recruitment Status :
Recruiting
First Posted : November 19, 2020
Last Update Posted : December 19, 2023
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | November 13, 2020 | ||||||||||||||
First Posted Date ICMJE | November 19, 2020 | ||||||||||||||
Last Update Posted Date | December 19, 2023 | ||||||||||||||
Actual Study Start Date ICMJE | June 2, 2021 | ||||||||||||||
Estimated Primary Completion Date | December 1, 2024 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
Sentinel Lymph Node (SLN) identification rate [ Time Frame: Up to 6 months ] 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Refining Local-Regional Therapy for IBC | ||||||||||||||
Official Title ICMJE | Refining Local-Regional Therapy for Inflammatory Breast Cancer (IBC) | ||||||||||||||
Brief Summary | This Feasibility study is trying to determine:
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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. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE | Procedure: Lymphoscintigraphy
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.
Other Name: Sentinel lymph node mapping
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Study Arms ICMJE | Experimental: Sentinal Node Identification
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.
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: Procedure: Lymphoscintigraphy
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||
Estimated Enrollment ICMJE |
50 | ||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
Estimated Study Completion Date ICMJE | December 1, 2027 | ||||||||||||||
Estimated Primary Completion Date | December 1, 2024 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04636710 | ||||||||||||||
Other Study ID Numbers ICMJE | 20-151 | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Faina Nakhlis, MD, Dana-Farber Cancer Institute | ||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||
Current Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||||||||||||
Verification Date | December 2023 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |