Breast CancerNCT02752009
Evaluation Of Lymph Nodes After Neoadjuvant Chemotherapy
A study testing Axillary Lymph Node Sampling Clip in people with Breast Cancer, run by Dana-Farber Cancer Institute.
Trial summary
This research protocol is studying the accuracy of the sentinel lymph node biopsy procedure in breast cancer patients who have cancer cells in the lymph nodes in the armpit (axilla) who have received chemotherapy or endocrine therapy prior to having surgery (neoadjuvant therapy). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Axillary Lymph Node Sampling Clip
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 26 Apr 2016to 21 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients will include any patients with biopsy-proven breast cancer and biopsy-proven axillary lymph node metastases at Beth Israel Deaconess Medical Center who are candidates for Neoadjuvant Chemotherapy or Neoadjuvant Endocrine therapy.
- A core needle biopsy or fine needle aspiration is acceptable for diagnosis of metastatic disease in lymph nodes.
- Patients will be identified as possible participants in the Radiology Imaging suites and Breast Surgery Clinics.
Who cannot join
- -Patients with inflammatory breast cancer or distant metastases will be excluded from participating in this study
About this study
Official title: Evaluation Of Axillary Lymph Node Metastases With Sentinel Lymph Node Biopsy After Neoadjuvant Therapy In Breast Cancer Patients
This research protocol is studying the accuracy of the sentinel lymph node biopsy procedure in breast cancer patients who have cancer cells in the lymph nodes in the armpit (axilla) who have received chemotherapy or endocrine therapy prior to having surgery (neoadjuvant therapy).
Read the detailed description
- This research study is a Pilot Study, which is the first time investigators are examining this study intervention locally; although this intervention has been studied nationally in published clinical trials.
- In this research study, the investigators are studying the accuracy of the sentinel lymph node biopsy procedure in breast cancer patients who have cancer cells in the lymph nodes in the armpit (axilla) who have received chemotherapy or endocrine therapy prior to having surgery (neoadjuvant therapy).
- A sentinel lymph node biopsy is a surgical evaluation of the lymph nodes in the underarm area in patients who have early breast cancer. Approximately, two-five nodes are removed from the underarm area for evaluation. The sentinel lymph node biopsy is performed in patients with breast cancer to determine if there are cancer cells in the lymph nodes in the armpit.
- The sentinel lymph node biopsy procedure is performed by injecting one or two dyes into the breast, which then travel to the armpit region via small vessels in the immune system. These nodes are called the sentinel lymph nodes. They represent the first nodes that drain the breast tissue. They are closely evaluated by a Pathologist to determine if cancer cells are present.
- This information allows physicians to know how far the cancer may have spread and recommend therapies accordingly.
- If sentinel lymph node biopsy is determined to be accurate in patients who are known to already have cancer cells in the axillary lymph nodes who receive neoadjuvant therapy, then in the future, many of the patients in this population may be spared the procedure of a full axillary lymph node dissection, which removes a larger number of lymph nodes and thus has increased risks and side-effects.
- Conditions
- Breast Cancer
- Being tested
- Axillary Lymph Node Sampling Clip
- Keywords
- Breast Cancer, Armpit lymph nodes Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary Lymph Node Sampling ClipProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Axillary Lymph Node Sampling Clip | Experimental | * Axillary Lymph Node Biopsy
-- Axillary lymph node sampling with clip placement into the sampled lymph node. After the tissue sampling of any suspicious nodes, a marker clip will be placed to allow for intra-operative identification of the biopsied nodes.
* Neoadjuvant therapy at the discretion of the treating Medical Oncologist. Once Neoadjuvant therapy is completed, surgery in the form of either Lumpectomy or Mastectomy is performed.
* Wire-localization of the clipped node on the day of surgery.
* Lymphatic mapping performed with either radiocolloid and/or blue dye.
* Sentinel lymph node biopsy will be performed on the day of surgery.
--- If the clipped node which contains the wire is not part of this sentinel lymph node specimen, then it will be removed separately and be sent to Pathology as a separate specimen.
* Axillary lymph node dissection as is the standard of care. Receives: Procedure: Axillary Lymph Node Sampling Clip |
What is being measured
The primary outcome is the main question the study is designed to answer.
False Negative Rate (FNR) Of Sentinel Lymph Node Biopsy At The Time Of Surgery
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study start26 Apr 2016
- Primary completion21 Dec 2016
- Study completion21 Dec 2016
Why it stopped: The data that would be generated is no longer clinically novel.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ranja Sharma, Dana-Farber Cancer Institute
- Investigators
- Ranjna Sharma, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752009
- Sponsor's protocol ID
- 15-494
- Status last verified
- Nov 2017
- First submitted
- 22 Apr 2016
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Axillary Lymph Node Metastases With Sentinel Lymph Node Biopsy After Neoadjuvant Therapy In Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02752009
- Acronym / sponsor ID
- 15-494
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Armpit lymph nodes Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The data that would be generated is no longer clinically novel.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 26 Apr 2016 (actual)
- Primary completion
- 21 Dec 2016 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research protocol is studying the accuracy of the sentinel lymph node biopsy procedure in breast cancer patients who have cancer cells in the lymph nodes in the armpit (axilla) who have received chemotherapy or endocrine therapy prior to having surgery (neoadjuvant therapy).
Detailed description
- This research study is a Pilot Study, which is the first time investigators are examining this study intervention locally; although this intervention has been studied nationally in published clinical trials.
- In this research study, the investigators are studying the accuracy of the sentinel lymph node biopsy procedure in breast cancer patients who have cancer cells in the lymph nodes in the armpit (axilla) who have received chemotherapy or endocrine therapy prior to having surgery (neoadjuvant therapy).
- A sentinel lymph node biopsy is a surgical evaluation of the lymph nodes in the underarm area in patients who have early breast cancer. Approximately, two-five nodes are removed from the underarm area for evaluation. The sentinel lymph node biopsy is performed in patients with breast cancer to determine if there are cancer cells in the lymph nodes in the armpit.
- The sentinel lymph node biopsy procedure is performed by injecting one or two dyes into the breast, which then travel to the armpit region via small vessels in the immune system. These nodes are called the sentinel lymph nodes. They represent the first nodes that drain the breast tissue. They are closely evaluated by a Pathologist to determine if cancer cells are present.
- This information allows physicians to know how far the cancer may have spread and recommend therapies accordingly.
- If sentinel lymph node biopsy is determined to be accurate in patients who are known to already have cancer cells in the axillary lymph nodes who receive neoadjuvant therapy, then in the future, many of the patients in this population may be spared the procedure of a full axillary lymph node dissection, which removes a larger number of lymph nodes and thus has increased risks and side-effects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axillary Lymph Node Sampling Clip | Experimental | Procedure: Axillary Lymph Node Sampling Clip* Axillary Lymph Node Biopsy -- Axillary lymph node sampling with clip placement into the sampled lymph node. After the tissue sampling of any suspicious nodes, a marker clip will be placed to allow for intra-operative identification of the biopsied nodes. * Neoadjuvant therapy at the discretion of the treating Medical Oncologist. Once Neoadjuvant therapy is completed, surgery in the form of either Lumpectomy or Mastectomy is performed. * Wire-localization of the clipped node on the day of surgery. * Lymphatic mapping performed with either radiocolloid and/or blue dye. * Sentinel lymph node biopsy will be performed on the day of surgery. --- If the clipped node which contains the wire is not part of this sentinel lymph node specimen, then it will be removed separately and be sent to Pathology as a separate specimen. * Axillary lymph node dissection as is the standard of care. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible patients will include any patients with biopsy-proven breast cancer and biopsy-proven axillary lymph node metastases at Beth Israel Deaconess Medical Center who are candidates for Neoadjuvant Chemotherapy or Neoadjuvant Endocrine therapy.
- A core needle biopsy or fine needle aspiration is acceptable for diagnosis of metastatic disease in lymph nodes.
- Patients will be identified as possible participants in the Radiology Imaging suites and Breast Surgery Clinics.
Key exclusion criteria (1 listed)
- -Patients with inflammatory breast cancer or distant metastases will be excluded from participating in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axillary Lymph Node Sampling Clip | Procedure or surgery | Axillary Lymph Node Sampling Clip |
Primary outcome
False Negative Rate (FNR) Of Sentinel Lymph Node Biopsy At The Time Of Surgery
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ranjna Sharma, MD principal investigator
Beth Israel Deaconess Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Axillary Lymph Node Sampling Clip in people with Breast Cancer, run by Dana-Farber Cancer Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
False Negative Rate (FNR) Of Sentinel Lymph Node Biopsy At The Time Of Surgery (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2017.