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Background: For many women with breast cancer, breast-conserving surgery is a critical first step in treatment with the goal of removing all cancer cells while minimizing the removal of healthy tissue. 15% to 25% or more of lumpectomy patients have positive margins and require a second surgery to achieve negative margins and reduce the risk of local recurrences. These positive margins are poorly predictive (35% PPV) of cancer left in the cavity, so most second surgeries find no residual cancer. Better detection tools are needed to identify residual cancer in real time during the initial lumpectomy to reduce the number of second operations. LUM015 is a protease-activated fluorescent imaging agent that accumulates in tumor cells and tumor associated macrophages. The LUM Imaging System camera visualizes the intravenously injected LUM015 in the lumpectomy cavity via a hand-held wide field detector and proprietary tumor detection software. This imaging system was previously tested in multiple single-site studies and a large, prospective multi-site study that enrolled 234 patients and showed good ability to detect residual cancer in the lumpectomy cavity. Trial Design: The current prospective multi-center, two-arm randomized, blinded study was designed to demonstrate the clinical efficacy, system accuracy, and safety of the LUM Imaging System. It aims to identify residual cancer in the lumpectomy cavity in order to reduce the rates of positive margins. This study seeks to enroll women with confirmed primary invasive breast cancer (IBC), ductal carcinoma in situ (DCIS) or a combination of IBC/DCIS undergoing a lumpectomy for their breast malignancy. The planned enrollment is 170 women being treated at fifteen medical centers across the US. To be eligible, patients must not have a history of allergic reaction to polyethylene glycol, intravenous contrast agents, or systemic therapies to treat their cancer. Use of blue dyes before imaging with the LUM System are not allowed. LUM015 is injected prior to the lumpectomy procedure. Surgeons perform standard of care (SOC) lumpectomy and perform blinded intraoperative imaging of the lumpectomy cavity with the LUM Imaging System in any regions where SOC shaves will be taken. The patient is then randomized either the further use of device or not. If the random assignment is to the device arm, the surgeon is directed to excise margins that the LUM System indicates are positive for cancer. Pathologists are blinded to the type of tissue removed when conducting the pathology assessment. Patient reported outcome data is collected as a quality of life survey before and after the subject's surgery. Additional detailed eligibility criteria are listed in the protocol. To date, 22 subjects have participated in this trial. This trial is registered as NCT03686215. Citation Format: Jorge Ferrer, David Carr, Irene Wapnir, Kelly Hunt, Peter Blumencranz, Nayana Dekhne, Daleela Dodge, Donna Lynn Dyess, Shelley Hwang, Stephanie Valente, Lynne Clark, Beth-Ann Lesnikoski, Anees Chagpar, Paticia Clark, Marie Catherine Lee, Brian Schlossberg, Sean Madden, Livia Gjylameti, Manna Chang, Kate Smith, Barbara Smith. Pivotal study of the LUM Imaging System for assisting intraoperative detection of residual cancer in the tumor bed of female patients with breast cancer [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr CT281.

Salvage mastectomy (SM) is the standard of care for patients with local recurrence (LR) after breast conservation therapy (BCT), often with immediate reconstruction. Complications of reconstruction are a concern for these patients, and long-term data are limited. We sought to compare rates of complications requiring re-operation (CRR) and reconstruction failure (RF) between autologous reconstruction (AR) and tissue expander/implant reconstruction (TE/I). Patients with locally recurrent breast cancer after BCT, treated with SM and immediate AR or TE/I between 2000 and 2008, were identified. CRR was defined as unplanned return to operating room for wound infection, dehiscence, necrosis (including flap, skin, or fat), hematoma, or hernia (for AR) and extrusion, leak, or capsular contracture (for TE/I). RF was defined as conversion to another reconstruction technique or to flat chest wall. This study included 103 patients with 107 reconstructions. Median follow-up was 6.6 years. CRR and RF were significantly higher with TE/I (n = 34) compared to AR (n = 73) at 5 years (50.9% vs 25.5%; P = 0.02) and (42.1% vs 5.8%; P < 0.001). On univariate analysis (UVA), TE/I (HR = 2.14; P = 0.02) and diabetes (HR = 5.10; P = 0.007) were significant predictors for CRR. On UVA, TE/I (HR = 7.30; P < 0.001) and older age at reconstruction (HR = 1.03; P = 0.003) were significant predictors for RF. In this population of previously irradiated patients, TE/I was associated with significantly higher CRR and RF. Complications continue to occur up to 10 years after TE/I. AR should be considered in appropriately selected patients, though TE/I may remain a reasonable option in patients without high-risk factors for surgical complications.

Oncotype DX recurrence score (RS) predicts risk of distant disease recurrence, and can guide chemotherapy recommendations in hormone positive, human epidermal growth factor 2-negative, early stage breast cancer. The present study aimed to evaluate the pattern of oncotype testing, RS and adjuvant treatment in patients undergoing intraoperative radiotherapy (IORT). Single center prospective data registry was queried for patients receiving IORT between October 2011 and February 2017. Patient demographics, tumor characteristics, RS, systemic therapy and recurrence information were analyzed. A total of 150 women with mean age of 70.8 years were included. The majority had invasive ductal cancer (60.6%) with 1.0 cm average tumor size and no lymph node involvement (99%). Oncotype testing was performed in 36 patients (24.3%). Low risk score (30) in one woman (3%). Patients with RS testing had significantly increased tumor sizes (1.2 vs. 1.0 cm; P

Autologous fat grafting (AFG) is utilized for cosmetic improvement of the reconstructed breast following mastectomy. Fat necrosis (FN), a benign complication of AFG, can raise suspicion of malignancy and require further evaluation. The aim of this study was to determine the incidence of FN in patients who have undergone AFG following mastectomy and reconstruction, and to identify factors contributing to FN. A retrospective chart review was conducted of all patients who received AFG following mastectomy and reconstruction at our institution between 2011 and 2016, with a minimum 6-month follow-up period. Patient information, operative details, receipt of radiation, complications, and incidence of cancer recurrence were collected. A total of 171 patients were included in this study. AFG was performed by seven surgeons. Patients received an average of 1.18 treatments, with average follow-up of 26 months. Eighteen patients (10.5%) developed FN an average of 3.4 months following AFG. Patients with a larger volume injected at initial session (p = 0.044) and longer length of follow-up (p = 0.026) had significant increases in risk of developing FN. Core needle biopsy was performed in seven patients and two patients required excision. The rate of cancer recurrence was 1.7% for all patients and 0% in the AFG cohort. Increased risk of FN following AFG is associated with greater volume injected at the initial session and higher incidence over time. Although AFG is oncologically safe, patients should be counseled on the 10.5% incidence of FN presenting as a palpable abnormality, and the approximately 5% chance of requiring biopsy or excision.

Negative surgical margins at the time of lumpectomy are essential to achieving optimal patient outcomes. Numerous techniques have been investigated to enhance the accuracy of intraoperative margin analysis. Achieving clear margins at the time of lumpectomy is important because it can facilitate time to treatment of the breast cancer patient and reduce the need for subsequent reoperative procedures to achieve negative margins.

Breast abscess is a common clinical problem. Management of these patients can be challenging and requires an understanding of pathophysiology and microbiology to achieve optimal outcomes. This chapter also highlights management considerations for granulomatous mastitis, periductal mastitis, and lactational abscesses

Benign breast disease constitutes any abnormality that upon further workup is found to be noncancerous and does not establish premalignant potential. Benign breast diseases can present in various ways, such as breast pain, a palpable breast lump, nipple discharge, or an imaging abnormality. Appropriate workup is essential to ensure that the new change is benign. This may entail additional imaging, biopsy, or surgery if necessary. Surgeons need to be able to recognize the presentation, appropriate workup, and treatment recommendations for the various benign breast diseases. This review addresses the broad range of benign breast lesions and their management recommendations. This review contains 7 figures, 5 tables and 54 references Key words: benign breast disease, breast cyst, breast mass, breast pain, idiopathic granulomatous mastitis, nipple discharge, papilloma, periductal mastitis, sclerosing adenosis

Objective The goal of the study was to evaluate trends in general surgery resident breast cases over the past 15 years. Study Design The Accreditation Council for Graduate Medical Education (ACGME) Case Logs Statistics Reports from 2000 to 2015 were reviewed for average breast-specific case numbers and trends over time. ACGME data were available for all cases and breast-specific cases including the following: excisional biopsy/lumpectomy, simple mastectomy, modified radical mastectomy, and sentinel lymph node excision. Setting The study evaluation was conducted at Cleveland Clinic, Cleveland, Ohio. Participants No individuals directly participated in this project. However, all general surgery residents at ACGME-accredited programs are represented in this analysis by virtue of the ACGME Case Logs Statistics Reports. Results Total residency case volume increased by 2% (2000-2015, p = 0.0159), with 2015 graduates logging 985.5 cases. In contrast, breast cases decreased by 17.1%. The largest drops were in modified radical mastectomy (61.5% decrease, p = 0.0001) and excisional biopsy/lumpectomy (25.8% decrease). Simple mastectomy increased from 6.0 to 10.8 cases (p = 0.0001). Sentinel lymph node excision fluctuated, but has been down-trending recently (67.3% decrease from 2010 to 2015, p = 0.0001). Decreased experience is occurring at both junior and senior resident levels. Conclusions Breast case operative experience for general surgery residents decreased by 17% between 2000 and 2015, despite increase in overall operative volume. Residents have less experience in more advanced cases including axillary management, raising concern about the proficiency of graduating surgeons with respect to these procedures. It is reasonable to set national minimums for resident breast operative experience to ensure that individuals are appropriately trained to perform these cases in practice.

Background We evaluated oncologic outcomes and complications of skin-sparing mastectomy (SSM) and nipple-sparing mastectomy (NSM) with immediate reconstruction (IR) after neoadjuvant chemotherapy (NAC) in patients with early-stage and locally advanced breast cancer (BC). Methods BC patients from 2000 to 2014 treated with NAC followed by SSM/NSM and IR were reviewed. Patient demographics, tumor characteristics, NAC response, complications, and recurrence were analyzed. Results Two hundred sixty-nine patients with 280 BCs were treated with NAC followed by SSM (94%) or NSM (6%) with IR. Median age was 47 (26-72) years with a median follow-up of 45 months. Pathologic complete response (pCR) was noted in 49 (17.5%) cases. Overall 30-day complication rate was 13.2%. Variables associated with complications included BMI (P

Introduction Intraoperative radiation with Intrabeam™ (IORT) for breast cancer is a newer technology recently implemented into the operating room (OR). This procedure requires time and coordination between the surgeon and radiation oncologist, who both perform their treatments in a single operative setting. We evaluated the surgeons at our center who perform IORT and their OR times to examine changes in OR times following implementation of this new surgical procedure. We hypothesized that IORT is a technique for which timing could be improved with the increasing number of cases performed. Methods A prospectively maintained IRB approved database was queried for OR times (incision and close) in patients who underwent breast conserving surgery (BCS), sentinel lymph node biopsy with and without IORT using the Intrabeam™ system at our institution from 2011 to 2015. The total OR times were compared for each surgeon individually and over-time. Next, the OR times of each surgeon were compared to each other. Continuous variables were summarized and then a prediction model was created using IORT time, OR time, surgeon, and number of cases performed. Results There were 5 surgeons performing IORT at our institution during this time period with a total of 96 cases performed. There was a significant difference observed in baseline surgeon specific OR time for BSC (p=0.03) as well as for BCS with IORT (p

Purpose. One benefit of intraoperative radiation therapy (IORT) is that it usually requires a single treatment, thus potentially eliminating distance as a barrier to receipt of whole breast irradiation. The aim of this study was to evaluate the distance traveled by IORT patients at our institution. Methods. Our institutional prospective registry was used to identify IORT patients from 10/2011 to 2/2017. Patient’s home zip code was compared to institution zip code to determine travel distance. Characteristics of local (100 miles) patients were compared. Results. 150 were patients included with a median travel distance of 27 miles and mean travel distance of 121 miles. Most were local (68.7%), with the second largest group living faraway (20.0%). Subset analysis of local patients demonstrated 20.4% traveled 1000 miles. The local, regional, and faraway patients did not differ with respect to age, race, tumor characteristics, or whole breast irradiation. Conclusions. Breast cancer patients are traveling for IORT, with 63% traveling >20 miles for care. IORT is an excellent strategy to promote breast conservation in selected patients, particularly those who live remote from a radiation facility.

Background: Obtaining tumor-free margins is critical for local control in breast conserving surgery. Currently, 20-40% of lumpectomy patients have positive margins that require surgical re-excision; this is a significant burden for patients, surgeons and the healthcare system. Therefore, it is of paramount importance that all cancer be resected from the tumor bed during lumpectomy surgery. The LUM Imaging System consists of a fluorescence-based imaging agent, a hand-held wide-field detector (LUM Imaging Device) used to image the surgical cavity walls intraoperatively in real-time after the resection of the main lumpectomy specimen, and a proprietary tumor detection algorithm that highlights regions in the tumor bed suspected to contain residual cancer. Methods: This multi-site clinical study is designed to refine the tumor detection algorithm developed in previous studies by correlating images generated by the LUM Imaging System with histopathology results. This is a prospective, interventional feasibility study and is an introductory arm to a pivotal study which will evaluate the safety and efficacy of the LUM Imaging System in reducing the positive margin rate during standard of care lumpectomies. Up to 250 adult female breast cancer patients undergoing lumpectomies are being enrolled at sixteen medical centers across the US. The novel imaging agent, LUM015, is injected into all enrolled subjects prior to their lumpectomy procedure. Subjects undergo the standard of care lumpectomy followed by intraoperative use of the LUM Imaging System which helps guide surgeons in identifying potential residual tumor tissue. The primary objective is to assess performance characteristics of the LUM Imaging System and to fine-tune the tumor detection algorithm. A secondary objective is to develop and refine the process of implementing the LUM Imaging System into institution-specific workflows during lumpectomies. A comprehensive process to evaluate the LUM Imaging System has been implemented and will be reported. This study is being conducted under an Investigational Device Exemption (IDE) approved by the FDA. To date, 72 subjects have been imaged using the LUM Imaging System. Successful implementation of standardized tissue collection, naming conventions, and LUM Imaging System training is intended to improve the quality and integrity of the data collected in the upcoming pivotal clinical trial to evaluate the safety and efficacy of the LUM Imaging System. This study is partially funded by a grant from the National Cancer Institute (award 1R44CA211013) to support biomedical technology development and Lumicell Inc. and is registered on Clinical Trials.gov as NCT03321929. Citation Format: Kate Smith, Jorge M. Ferrer, Barbara L. Smith, E. Shelley Hwang, Kelly K. Hunt, Daleela G. Dodge, Stephen E. Karp, Stephanie A. Valente, Irene L. Wapnir, Lynne P. Clark, David R. Carr, Peter D. Beitsch, Donna L. Dyess, Beth-Ann Lesnikoski, Peter W. Blumencranz, Nayana S. Dekhne, Linsey P. Gold, Anees Chagpar, Katherine Kacena, Livia Gjylameti, Felix Geissler. Expansion into multiple institutions for training in the use of the LUM Imaging System for intraoperative detection of residual cancer in the tumor bed of female subjects with breast cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr CT220.

One in eight American women develops breast cancer. Of the many patients requiring mastectomy yearly as a consequence, most elect some form of breast reconstruction. Since 2006, only silicone breast implants have been approved by the FDA for the public use. Unfortunately, over one-third of women with these implants experience complications as a result of tissue-material biocompatibility issues, which may include capsular contracture, calcification, hematoma, necrosis and implant rupture. Our group has been working on developing alternatives to silicone. Linear triblock poly(styrene-b-isobutylene-b-styrene) (SIBS) polymers are self-assembling nanostructured thermoplastic rubbers, already in clinical practice as drug eluting stent coatings. New generations with a branched (arborescent or dendritic) polyisobutylene core show promising potential as a biomaterial alternative to silicone rubber. The purpose of this pre-clinical research was to evaluate the material-tissue interactions of a new arborescent block copolymer (TPE1) in a rabbit implantation model compared to a linear SIBS (SIBSTAR 103T) and silicone rubber. This study is the first to compare the molecular weight and molecular weight distribution, tensile properties and histological evaluation of arborescent SIBS-type materials with silicone rubber before implantation and after explantation.

Background Breast cancer is the most frequently occurring cancer in women of reproductive age, and systemic treatments may adversely affect childbearing plans. Use of assisted reproductive technologies and therapies for ovarian protection improve fertility prospects. We evaluated whether patients had a documented fertility discussion (FD) with their oncology physician prior to therapy, what options were chosen, and if pregnancy was achieved.

Pertuzumab is FDA approved in the preoperative setting in combination with trastuzumab and chemotherapy, in women with nonmetastatic HER2 + breast cancer. The TRYPHAENA trial (n = 77) reported a pathologic complete response rate (pCR), i.e., ypT0ypN0, of 52 % in patients treated with neoadjuvant (docetaxel, carboplatin, trastuzumab,pertuzumab) TCH-P. Aside from this study, there is limited information regarding the safety and efficacy of TCH-P in the neoadjuvant setting. Our goal was to evaluate the safety and efficacy of neoadjuvant TCH-P in a non-clinical trial setting.Cancer data registry was utilized to identify patients with HER2 + nonmetastatic breast cancer that received neoadjuvant TCH-P. pCR was defined as the absence of invasive or noninvasive cancer in breast and lymph nodes, i.e., ypT0ypN0.70 patients with a median age of 52 years met our inclusion criteria. Clinical staging was I-8.5 %; II-68.5 %; and III-22.8 %. 60 % of patients had hormone receptor (HR)-positive tumors. 23 % (16/71) of patients required dose reduction for rash, diarrhea, neuropathy, or thrombocytopenia. Overall, no patients developed grade 3-4 left ventricular systolic dysfunction(LVSD); an asymptomatic reduction in LVEF of 10 % was observed in three patients. The overall observed pCR rate was 53 %. As expected, the pCR rate was higher in patients with HR-negative breast cancer than for patients with HR+ disease: 69 % (20/29) vs. 42 % (17/41), respectively. The axillary downstaging rate was approximately 53 % (19/36).Neoadjuvant TCH-P, in a nonclinical trial setting, was associated with a pCR rate of 53 % similar the reported rate in TRYPHAENA. Toxicity was manageable, with no patients experiencing symptomatic heart failure.

Breast cancer is the most frequently occurring cancer in women of reproductive age, and systemic treatments may adversely affect childbearing plans. Use of assisted reproductive technologies and therapies for ovarian protection improve fertility prospects. We evaluated whether patients had a documented fertility discussion (FD) with their oncology physician prior to therapy, what options were chosen, and if pregnancy was achieved.A retrospective chart review from 2006 to 2014 was performed to evaluate women aged 40 years and younger who were diagnosed with breast cancer and treated with chemotherapy and/or antihormonal therapy. Patient demographics, treatment regimens, presence or absence of FD, in vitro fertilization (IVF) consultation, gonadotropin-releasing hormone (GnRH) agonist use, and subsequent successful pregnancy were analyzed.Among 303 patients meeting the inclusion criteria, 80 (26 %) had an FD with their physician documented; 71 of these 80 women (89 %) sought further fertility consultation and options. Sixteen (20 %) women were prescribed a GnRH agonist only for ovarian protection during chemotherapy, 50 (63 %) underwent IVF consultation only, and 5 (6 %) had both a GnRH agonist prescribed and an IVF consultation. The overall pregnancy rate was 7 % at a mean of 3 years post breast cancer treatment. Pregnancy after treatment was more common among those pursuing IVF consultation or prescribed a GnRH agonist.In treating young breast cancer patients, it is important to assess fertility desire, discuss treatment risks relating to fertility, and discuss preservation options. Although not every woman in this group desired pregnancy, 71/80 (89 %) women having a documented FD sought further fertility consultation and options.

Single-dose intraoperative radiotherapy (IORT) is an emerging treatment for women with early stage breast cancer. The objective of this study was to define the frequency of IORT use, patient selection, and outcomes of patients treated in North America.A multi-institutional retrospective registry was created, and 19 institutions using low-kilovoltage IORT for the treatment of breast cancer entered data on patients treated at their institution before July 31, 2013. Patient selection, IORT treatment details, complications, and recurrences were analyzed.From 2007 to July 31, 2013, a total of 935 women were identified and treated with lumpectomy and IORT. A total of 822 patients had at least 6 months' follow-up documented and were included in the analysis. The number of IORT cases performed increased significantly over time (p 0.001). The median patient age was 66.8 years. Most patients had disease that was2 cm in size (90 %) and was estrogen positive (91 %); most patients had invasive ductal cancer (68 %). Of those who had a sentinel lymph node procedure performed, 89 % had negative sentinel lymph nodes. The types of IORT performed were primary IORT in 79 %, secondary IORT in 7 %, or planned boost in 14 %. Complications were low. At a median follow-up of 23.3 months, crude in-breast recurrence was 2.3 % for all patients treated.IORT use for the treatment of breast cancer is significantly increasing in North America, and physicians are selecting low-risk patients for this treatment option. Low complication and local recurrence rates support IORT as a treatment option for selected women with early stage breast cancer.

Advances in the management of patients with HER-2+ breast cancer with combinatorial targeted therapies are leading to unprecedented rates of pathologic complete response. The high rates of complete pathologic response in the breast and the axillary lymph nodes following neoadjuvant therapy are raising new questions about the role of local therapies (surgery and radiation therapy) in treating these patients. The safe elimination of surgery and radiation therapy for selected breast cancer patients would ultimately reduce the short- and long-term morbidity associated with traditional breast cancer treatments and would represent a major step forward. However, numerous technical and clinical challenges remain which will be discussed in this chapter. Collaborative efforts to address these challenges are essential to improving current therapeutic approaches for patients with HER-2+ breast cancer.

Accelerated partial breast irradiation (APBI) is an alternative to receiving whole breast radiation in carefully selected patients. Because breast cancer local recurrence rates are low and follow-up has been short-term, the exact cause of recurrences after APBI has been difficult to evaluate. We report the first case of documented radiation balloon catheter malpositioning that resulted in local recurrence. Patients undergo CT imaging of the breast after radiation balloon catheter placement for radiotherapy treatment planning, which evaluates adequate conformance of the balloon to the surrounding breast parenchyma and confirms a >7 mm distance between the balloon surface and the skin surface. Although true local recurrences are rare in appropriately selected partial breast irradiation candidates, inadvertent malpositioning of the radiation treatment catheter can increase the risk. This case is presented to illustrate the importance of comparing CT radiation planning images, with treatment catheter in place, to the original diagnostic breast imaging studies to confirm proper catheter positioning (in addition to measuring balloon to skin distance and conformance) prior to initiating radiotherapy.

Background. Axillary lymph node status continues to be among the most important prognostic variables regarding breast cancer survival. We were interested in our ability to accurately predict axillary nodal involvement by using physical examination and standard breast imaging studies in combination. Methods. A retrospective review was performed of 244 consecutive patients diagnosed with invasive breast carcinoma between May 2008 and December 2010 who underwent physical examination of the axilla, digital mammography, axillary ultrasonography, and contrastenhanced breast magnetic resonance imaging and who had subsequent histopathologic evaluation of one or more axillary lymph nodes. Results. A total of 62 (25%) of 244 women were found to have positive axillary lymph nodes on final histopathologic examination, 42% of whom were able to be identified preoperatively. The sensitivity for predicting axillary metastasis if any one or more examination modalities were suspicious was 56.5%. The specificity for predicting axillary metastasis if any three or more modalities were suspicious was 100%. Of the patients who had all four modalities negative, 14% were ultimately found to have histologically positive nodes at the time of surgery. Conclusions. Physical examination and multimodal imaging in combination are useful for preoperative axillary staging and treatment planning. However, they remain inadequate definitive predictors of axillary lymph node involvement.

Background: Standard surgical techniques result in positive lumpectomy margins 20-40% of the time. These positive margins require surgical re-excision which places significant burden on the healthcare system and patients. The LUM Imaging System consists of a fluorescence-based imaging agent, a hand-held wide-field detector (LUM Imaging Device) used to image the surgical cavity walls intraoperatively in real-time after the resection of the main lumpectomy specimen, and a proprietary tumor detection algorithm that highlights regions in the tumor bed suspected to contain residual cancer. This imaging system was previously tested in a single-site clinical study. The current study is evaluating the imaging system in a multi-study, large patient cohort. Trial Design / Methods This trial (NCT03321929) is a non-randomized, open-label, multi-site trial designed to further refine the tumor detection algorithm utilized by the LUM Imaging System. This is a prospective, interventional feasibility study and is a pilot arm to a pivotal study which will evaluate the safety and efficacy of the LUM Imaging System. Up to 250 adult female breast cancer patients undergoing lumpectomies are being enrolled at sixteen medical centers across the US. LUM015, a fluorescence-based imaging agent, is injected prior to the subject’s lumpectomy procedure. Surgeons perform their standard of care lumpectomy followed by intraoperative imaging of the lumpectomy cavity with the LUM Imaging System. Specific Aims The primary objective is to assess performance characteristics of the LUM Imaging System and to refine the tumor detection algorithm. A secondary objective is to develop and refine the process of implementing the LUM Imaging System into institution-specific workflows during lumpectomies. Eligibility Criteria This study seeks to enroll women, over the age of 18 and with histologically or cytologically confirmed primary invasive breast cancer (IBC), ductal carcinoma in situ (DCIS) or a combination of IBC/DCIS undergoing a lumpectomy for their breast malignancy. In addition to be willing to follow study procedures, participating in an informed consent discussion, signing an informed consent form, and having baseline lab and screening values within protocol limits, enrolled subjects must meet the following key exclusion criteria: have no history of allergic reaction to polyethylene glycol, no history of allergic reaction to intravenous contrast agents, have not undergone any systemic therapies to treat their cancer, and will not be administered methylene blue or other dye for sentinel lymph node detection during their lumpectomy. Additional detailed eligibility criteria are listed in the protocol. Statistical Methods For categorical variables, summary tabulations of the number and percentage of patients within each category (with a category for missing data) of the parameter will be presented. For continuous variables, the number of patients, mean, median, standard deviation, minimum, and maximum values will be presented. The secondary objective will be met by evaluating a robust training and proficiency protocol for all enrolling institutions. Accrual To date, 208 subjects have participated in this LUM Imaging System trial. Contact Information Jorge Ferrer: jmferrer@lumicell.com Kate Smith: kate@lumicell.com Citation Format: Kate Smith, Jorge Ferrer, David Carr, Peter Blumencranz, Daleela Dodge, Nayana Dekhne, Irene Wapnir, Kelly Hunt, Linsey Gold, Stephanie Valente, Peter Beitsch, Donna Dyess, Shelly Hwang, Lynne Clark, Beth-Ann Lesnikoski, Anees Chagpar, Stephen Karp, Brian Schlossberg, Livia Gjylameti, Barbara Smith. Expansion into multiple institutions for training in the use of the LUM Imaging System for intraoperative detection of residual cancer in the tumor bed of female subjects with breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr OT3-06-02.

Milk fistula is an uncommon condition which occurs when there is an abnormal connection that forms between the skin surface and the duct in the breast of a lactating woman, resulting in spontaneous and often constant drainage of milk from this path of least resistance. A milk fistula is usually a complication that results from a needle biopsy or surgical intervention in a lactating patient. Here, the authors present an unusual case of a spontaneous milk fistula which developed from an abscess in the breast of a lactating woman. The patient initially presented to the office with a large open wound on her breast, formed from skin breakdown, within which milk was pooling. She was treated with local wound care and cessation of breastfeeding, with appropriate healing of the wound and closure of the fistula with 6 weeks. Diagnosis, prevention, and treatment of milk fistula were reviewed.

Breast magnetic resonance imaging (MRI) has been repeatedly shown to have a high false-positive rate for additional findings in the breast resulting in additional breast imaging and biopsies. We hypothesize that breast MRI is also associated with a high rate of false-positive findings outside of the breast requiring additional evaluation, interventions, and delays in treatment. We performed a retrospective review of all breast MRIs performed on breast cancer patients in 2010 at a single institution. MRI reports were analyzed for extra-mammary findings. The timing and yield of the additional procedures was also analyzed. Three hundred and twenty-seven breast cancer patients (average age = 53.53 ± 11.08 years) had a breast MRI. Incidental, extra-mammary findings were reported in 35/327 patients (10.7%) with a total of 38 incidental findings. The extra-mammary findings were located in the liver (n = 21, 60.0%), thoracic cavity (n = 12, 34.3%), kidneys (n = 1, 2.9%), musculoskeletal system (n = 3, 8.6%), and neck (n = 1, 2.9%). Eighteen of the 35 patients (51.4%) received additional radiographic imaging, 3 (8.6%) received additional laboratory testing, 2 (5.7%) received additional physician referrals and 2 (5.7%) received a biopsy of the finding. The average time to additional procedures in these patients was 14.5 days. None of the incidental, extra-mammary findings were associated with breast cancer or other malignancy. Breast MRI was associated with a high rate (10.7%) of extra-mammary findings, which led to costly additional imaging studies, referrals, and tests. These findings were not associated with breast cancer or other malignancies. Extra-mammary findings highlight an unrecognized adverse consequence of breast MRI.

Currently, no standard guidelines exist regarding routine screening imaging in breast cancer patients following autologous reconstruction. Concern over nonpalpable chest wall recurrence has prompted many to pursue screening imaging. We analyzed the pattern of locoregional recurrence (LRR) and yield of screening imaging and exam in these patients. We performed a retrospective chart review of all patients who had mastectomy with autologous reconstruction between 2000 and 2009. Presentation of LRR and utility of imaging and breast exam were analyzed. Screening mammography was performed at the discretion of the treating physicians. A total of 615 patients were identified and follow-up data were available for 541. Median follow-up from time of reconstruction was 7 years. Twenty-seven patients developed a LRR (5.0 %). Among patients screened with mammography (n = 397), an abnormality led to 25 biopsies in 25 patients, and 2 were malignant (8 %). Among patients receiving routine clinical exam (n = 537), an abnormality led to 77 biopsies in 66 patients, and 30 were malignant (39 %). The median time from cancer surgery to LRR was 2.6 years. LRR was detected on clinical exam in 24 of 27 patients (88.9 %). Screening mammography detected two recurrences that were palpable on follow-up exam. One patient had an incidental chest wall recurrence found on PET/CT. In summary, 26 of 27 (96.3 %) patients had a clinically detectable LRR. Diligent surveillance with clinical breast exam is a reliable method of detecting LRR after autologous reconstruction, identifying 96.3 % of recurrences in our study. Our results do not support routine mammographic screening in this population.

Accelerated partial breast irradiation (APBI) is an alternative to receiving whole breast radiation in carefully selected patients. Because breast cancer local recurrence rates are low and follow-up has been short-term, the exact cause of recurrences after APBI has been difficult to evaluate. We report the first case of documented radiation balloon catheter malpositioning that resulted in local recurrence. Patients undergo CT imaging of the breast after radiation balloon catheter placement for radiotherapy treatment planning, which evaluates adequate conformance of the balloon to the surrounding breast parenchyma and confirms a7 mm distance between the balloon surface and the skin surface. Although true local recurrences are rare in appropriately selected partial breast irradiation candidates, inadvertent malpositioning of the radiation treatment catheter can increase the risk. This case is presented to illustrate the importance of comparing CT radiation planning images, with treatment catheter in place, to the original diagnostic breast imaging studies to confirm proper catheter positioning (in addition to measuring balloon to skin distance and conformance) prior to initiating radiotherapy.

Aging is associated with a decline in immune function. This may contribute to decreased ability of an elderly patient to mount an appropriate innate inflammatory response when injured. This study examined elderly trauma patients to determine whether there was a difference in neutrophil response to injury when compared with controls.This prospective, observational, cohort study compared neutrophil function in 24 injured elderly (older than 65 years) patients admitted to our trauma center to control groups of noninjured individuals (11 elderly and 17 young). Blood samples were also taken from the injured elderly group within 48 hours of trauma and subsequently at two periods during their hospital stay. A single blood sample was obtained from the noninjured control groups. Neutrophils were analyzed for CD18 expression, stimulated oxidative burst, apoptosis, and IL-10. Results were compared using one-way analysis of variance (alpha 0.05). This study was approved by the Institutional Review Board.Twenty-four injured elderly subjects were enrolled: mean injury severity score 15.3, average age 74.6 years, 92% survival, 100% blunt trauma. CD18 levels in the elderly injured subjects for all three time periods were significantly higher than both control groups. When evaluated between controls, CD18 for the noninjured elderly (NIE) was also significantly higher than the noninjured young (NIY). The neutrophil stimulated oxidative burst in the injured elderly subjects at time periods 1, 2, and 3 was not significantly different from the NIY controls. However, the injured elderly had a significantly higher oxidative burst at time period 3 than the NIE controls. Apoptosis in the injured elderly subjects was significantly lower in all three time periods than the NIY. There was no difference in apoptosis between the injured elderly subjects when compared with the NIE controls. There was no significant difference in IL-10 expression among groups.Injury results in differences in innate immune function in the elderly when compared with controls. The clinical significance of this is uncertain and warrants further investigation.

531 Background: Pertuzumab is FDA approved for use in combination with trastuzumab and chemotherapy as neoadjuvant therapy in women with non-metastatic HER2+ breast cancer. The TRYPHAENA trial repo...