CLINICAL TRIAL

Lymphoscintigraphy for Inflammatory Breast Neoplasms

Stage III
Recruiting · 18+ · Female · Boston, MA

Refining Local-Regional Therapy for IBC

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About the trial for Inflammatory Breast Neoplasms

Eligible Conditions
Inflammatory Breast Neoplasms · Breast Cancer · Inflammatory Breast Cancer (IBC) · Breast Neoplasms · Sentinel Lymph Node

Treatment Groups

This trial involves 2 different treatments. Lymphoscintigraphy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Lymphoscintigraphy
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lymphoscintigraphy
2012
Completed Phase 2
~530

Eligibility

This trial is for female patients aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The subject must be able to understand the consent document and be willing to comply with the study procedures, including the research biopsy show original
The symptoms of SLE come on very suddenly in most people show original
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
The individual has an ECOG performance status of ≤2, meaning that they are moderately limited in their activities. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Within 2 years from surgery
Screening: ~3 weeks
Treatment: Varies
Reporting: Within 2 years from surgery
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Within 2 years from surgery.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Lymphoscintigraphy will improve 1 primary outcome and 4 secondary outcomes in patients with Inflammatory Breast Neoplasms. Measurement will happen over the course of Within 2 yhears from surgery.

Disease-free survival (DFS)
WITHIN 2 YHEARS FROM SURGERY
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.
WITHIN 2 YHEARS FROM SURGERY
Sentinel Lymph Node (SLN) identification rate
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.
UP TO 6 MONTHS
Prevalence of lymphedema
EVERY 6 MONTHS POST SURGERY UP TO 2 YEARS
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).
EVERY 6 MONTHS POST SURGERY UP TO 2 YEARS
Local-regional recurrence free survival rate (LRRFS)
WITHIN 2 YEARS FROM SURGERY
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).
WITHIN 2 YEARS FROM SURGERY
Distant recurrence-free survival rate (DRFS)
WITHIN 2 YEARS FROM SURGERY
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
WITHIN 2 YEARS FROM SURGERY

Who is running the study

Principal Investigator
F. N.
Faina Nakhlis, MD
Dana-Farber Cancer Institute

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does inflammatory breast neoplasms run in families?

No IBN families had an association with BRCA1 or BRCA2 mutations, no IBN families with a history of breast cancer, and only a minority of families with IBN exhibited clustering of other medical conditions suggestive of a genetic linkage. Therefore, [IBN is] not considered to be hereditary and is not eligible for inclusion in national BRCA screening programs.

Anonymous Patient Answer

Has lymphoscintigraphy proven to be more effective than a placebo?

In view of its advantages over a placebo, the LYNS may provide a useful adjunct for the diagnosis and staging of breast cancer and for predicting an appropriate treatment.

Anonymous Patient Answer

Can inflammatory breast neoplasms be cured?

IBN is essentially a benign, but curable, disease. We found no difference between NAFE and LNP with respect to outcomes. However, women with IBN appear to have a slightly higher rate of breast-sparing treatment compared to those with LNP and NAFE and therefore may have a better outcome.

Anonymous Patient Answer

What are the signs of inflammatory breast neoplasms?

The following signs and symptoms are associated with IBN: IBN-specific symptoms occur in approximately 25% of patients, pain (30% of patients) may be localized to the affected breast, and mastectomy is necessary to achieve tumor eradication in over 60% of patients.

Anonymous Patient Answer

What causes inflammatory breast neoplasms?

The etiology of IBs was not definitively proven in this study. We can only make suggestions about this uncertain etiology. For example, it is possible that cigarette smokers might be more prone to developing IBs. If smokers are exposed to ionizing radiation, the incidence of IBs might be increased by increased exposure to ionizing radiation or even to the medications that were used in this study. A correlation between exposure to ionizing radiation and IBs has been suggested. Patients with familial carcinomas should be excluded to rule out a hereditary disposition in this study, but a clear etiology of IBs has not been definitively established. In addition, we hypothesize that cigarette smokers may be at high risk in developing breast cancer.

Anonymous Patient Answer

How many people get inflammatory breast neoplasms a year in the United States?

Inflammatory breast neoplasms account for a small percentage of early-stage breast cancers cases in the USA, with an estimated incidence of 0.9 cases per 100,000 women every year, according to current available data.

Anonymous Patient Answer

What is inflammatory breast neoplasms?

The diagnosis of IBN depends on finding typical histopathologic findings of a lymphocytic infiltrate around the ductal system in addition to typical IBC histopathology. This diagnostic step enables classification of IBN into 3 groups: classic, nodular, and tubular variants according to the findings. The nodular variant is the most common IBN variant and, because of its heterogeneity, may require a different approach in terms of treatment strategies.

Anonymous Patient Answer

What are common treatments for inflammatory breast neoplasms?

Breast neoplasms are treated with surgery through mammary conservation techniques or mastectomy for large or early-stage invasive tumors; with mastectomy for local or low-stage ductal carcinoma; or with mastectomy with irradiation or with chemo-radiation for high-risk cases of recurrent or high-risk high-grade malignancy. A comprehensive approach is warranted to treat infiltrative neoplasms, and a number of therapy modalities have been introduced to our institution, including conservative surgery, radiotherapy, hormonal therapy and chemotherapy. Intensive research has been ongoing for over 30 years to develop a consensus therapeutic modality for this type of malignancy.

Anonymous Patient Answer

How does lymphoscintigraphy work?

Lymphoscintigraphy may be helpful in staging and staging [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) subtypes. It is more useful for determining nodal basin involvement in T1 breast cancers, and is most helpful in localizing extra-axillary and/or in-axillary nodal disease in T1-2 breast cancers. Lymphoscintigraphy is also very useful in evaluating axillary, mediastinal, and para-aortic nodal basin drainage in advanced stage breast carcinomas. The role of lymphoscintigraphy in early breast cancer staging needs to be further studied and standardized and should become a standard part of staging work-up for breast cancer.

Anonymous Patient Answer

Have there been other clinical trials involving lymphoscintigraphy?

Most recent studies of LSG were uncontrolled. Results from a recent clinical trial of the present report suggest that there is an active role of LSG in predicting the occurrence of some IFLs and in detecting the progression of IFLs. However, larger-scale, controlled trials are necessary before the use of LSG can be recommended.

Anonymous Patient Answer

What are the latest developments in lymphoscintigraphy for therapeutic use?

The development of new diagnostic procedures has changed the way physicians diagnose breast diseases and have improved treatment as well. It remains an open issue whether LSUS and LN guided SLN sampling is more cost effective than LSUS guided ALND. Therefore, more comprehensive analyses are of more relevance than cost effectiveness of imaging and surgery/oncology for diagnosis of breast pathology in order to prevent and treat the disease as soon as possible.

Anonymous Patient Answer

Have there been any new discoveries for treating inflammatory breast neoplasms?

Although there are advances in the treatment of inflammatory breast neoplasms, our research in the past year may lead to new approaches for treating this disease. Current research involves evaluating the efficacy and safety of novel therapeutic agents that are also being studied in the treatment of breast cancer. Further examination of the role of tumor infiltrating lymphocytes in breast tumors may lead to new therapies for treating inflammatory breast neoplasms as well.

Anonymous Patient Answer
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