Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Carcinoma, Ductal

Carcinoma in Situ

Carcinoma, Lobular

Breast Carcinoma In Situ

Carcinoma, Intraductal, Noninfiltrating

Carcinoma, Ductal, Breast

Breast Diseases

Skin Diseases

30 mastectomy, partial mastectomy, and mammoplasty samples will be analyzed to define the effective post-excision time window in which the device must be used before the results can no longer be evaluated. The mammoplasty specimens are necessary to assess normal tissue outcomes.

25 Partial Mastectomy cases will be analyzed to distinguish between different implementation methods of the technology.

Nimmi Ramanujam, PhD

The objective of the proposed research is to develop a clinical-trial-ready device and to evaluate its practical utility as a routinely used intra-operative tool. Our multidisciplinary group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. The proposed technology will be a multi-channel optical assay device for intra-operative imaging of margins in specimens excised from patients undergoing breast conserving surgery (partial mastectomy) or mastectomy.

Fast Spectral Imaging Device for Tumor Margin Mapping

(1) In order to define the effective post-excision time window in which the device must be used, which ultimately has bearings on the final product indications for use. (2)To analyze the different methods of implementation of the technology.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Duke University

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Intra-operative Radiation Therapy - IORT

A. M. Nisar Syed, MD

The purpose of this trial is to assess the efficacy of the Xoft Axxent eBx System when used for single-fraction IORT in early stage breast cancer. A comparison will be made to the current standard of care, whole breast irradiation (WBI), in women with early stage breast cancer.

The rationale for IORT as the sole radiation therapy is:

Favorable preliminary results in feasibility, safety and efficacy outcomes: Accelerated Partial Breast Irradiation (APBI) is an accepted alternative to whole breast irradiation following breast-conserving surgery for early stage breast cancer. Intra-Operative Radiation Therapy (IORT) is a form of APBI that allows radiation to be delivered directly to the open tumor bed following Breast Conservation Surgery (BCS). After 4 years of follow-up, IORT has shown equivalent disease control rates as whole breast irradiation.

Direct and timely radiation to the tumor bed: Radiation is delivered at to the target tissue (adjacent to the resection margins at the time of lumpectomy). It avoids treatment delays and eliminates weeks or months of post-surgical radiation therapy during which residual cancer cells might proliferate. An in vitro study showed that un-irradiated wound fluid stimulated the growth of breast cancer cells while irradiated wound fluid did not. Each month of delay in radiation treatment is associated with a 1% increase in the recurrence rate. Huang, et al., found a 5.8% recurrence rate in patients who received WBRT within 8 weeks of BCS compared with a 9.1% recurrence rate in patients who started radiotherapy 9-16 weeks after BCS.

Increased patient treatment compliance compared to conventional radiation therapy: Suitable early stage breast cancer patients are able to complete their breast cancer radiotherapy treatment at the time of BCS, which offers a convenient and potentially life-saving benefit to patients who might otherwise omit radiation therapy if it required lengthy travel or time commitments. In addition, healthcare resources, including both personnel and facilities, will be conserved by eliminating the overhead cost of multiple patient visits, eliminating waiting time for patients, and consolidating therapy to one visit combined with the surgical procedure.

Available Technology: The Xoft Axxent controller, x-ray source, and balloon applicator are cleared by the United States Food and Drug Administration (FDA) to deliver brachytherapy treatments using high dose rate x-ray radiation. The Xoft Axxent System has been used to treat breast cancer subjects using a multi-fraction APBI technique on an outpatient basis as part of two multi-center studies. The Xoft Axxent System enables the Radiation Oncologist to administer electronic brachytherapy without the use of a radioactive isotope in minimally shielded rooms. Characteristics of the Xoft System that make it well-suited for IORT include its portability and low energy photons, allowing for minimal shielding during the radiation therapy.

This protocol has been developed to further study the use of the Xoft Axxent eBx System in the delivery of IORT for subjects with early-stage breast cancer. The Xoft Axxent eBx System will be used according to the United States Food and Drug Administration (FDA) 510(k) cleared labeling; therefore, the use of the technology in this study is considered on-label and within the scope of the FDA cleared indication.

Single 20Gy dose of electronic brachytherapy (IORT)

An Efficacy Study of the Xoft® Axxent® eBx® IORT System® "Lite"

An Efficacy Study of Intra-Operative Radiation Therapy (IORT) Using the Xoft Axxent eBx System at the Time of Breast Conservation Surgery for Early Stage Breast Cancer "Lite"

To assess the rate of ipsilateral breast tumor recurrence in subjects treated with the Xoft Axxent Electronic Brachytherapy System when used for single-fraction, intra-operative radiation therapy treatment of early stage breast cancer when compared to whole breast irradiation (WBI) at 5 years of follow-up

Icad, Inc.

Xoft, Inc.

All patients will undergo a partial mastectomy with sentinel lymph node biopsy with the goal of achieving a margin-negative resection while maintaining good cosmetic outcome. Immediately following partial mastectomy and frozen section evaluation of the sentinel lymph nodes, IORT is to be delivered. Intraoperative radiation therapy will involve 50 kV xrays to a dose of 20 Gy during breast conserving surgery. After surgery, patients are followed based on the standard schedule determined by their surgeon for 5 years.

Intraoperative radiation therapy with INTRABEAM system to a dose of 20 Gy

IORT

Lynn Shaffer, PhD

Malolan S Rajagopalan, MD

Malolan Rajagopalan, MD

This is a prospective, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence. Secondary aims include identification of acute- and late-toxicity, cosmetic result, disease-free survival and overall survival.

IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

Intraoperative Radiation Therapy (IORT) Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

Ipsilateral In-Breast Tumor Recurrence (IBTR): defined as biopsy-proved invasive or in situ breast cancer (except LCIS) in the ipsilateral breast.

Degree of late radiation toxicity will be scored based upon RTOG/EORTC (Radiation Therapy Oncology Group/Eastern Oncology Radiation Therapy Consortium) late radiation morbidity scoring schema for subcutaneous tissue as well as cosmetic result.

The RTOG/EORTC late radiation morbidity scoring schema on subcutaneous tissue is as follows:

* GRADE 1: Slight induration (fibrosis) and loss of subcutaneous fat
* GRADE 2: Moderate fibrosis but asymptomatic; slight field contracture; \<10% linear reduction
* GRADE 3: Severe induration and loss of subcutaneous tissue; field contracture \> 10% linear measurement
* GRADE 4: Necrosis

Acute radiation toxicity will be scored at the first follow-up visit after IORT (4-6 weeks after treatment).

Radiation dermatitis will be scored based upon CTCAE (Common Terminology Criteria for Adverse Events) v4.03 scale as follows:

* GRADE 1: Faint erythema or dry desquamation
* GRADE 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema
* GRADE 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion
* GRADE 4: Life threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated

Other acute toxicity will also be scored per the CTCAE v4.03 scale and will be rated on the relation to radiation therapy (definitely related, probably related, possibly related, unlikely related, unrelated)

Mount Carmel Health System

Rare Diseases

Inflammatory Breast Neoplasms

Inflammatory Breast Cancer

PET scan after course 1 and surgery after 8 courses

Fernando Cabanillas, MD

A PET scan drop less than 20% in SUVs or below a certain absolute SUV value after the first course of neoadjuvant chemotherapy can predict pathological response, and could in the future lead to an early surgical intervention.

The use of neo-adjuvant systemic therapy in women recently diagnosed with breast cancer is growing in popularity based on its proven benefit (1). Pre-operative chemotherapy not only can assist in regards to breast conservation therapy (2) but data suggest prognostic benefits in those subset of patient's obtaining complete pathological response (3,4) .

It is imperative for clinicians to detect as early as possible those patients likely to obtain the desired clinical and /or pathologic response, thus identifying those patients who don't benefit from the first line neoadjuvant treatment so that their treatment can be modified accordingly.

Response to treatment based on clinical data or structural imaging, usually requires several chemotherapeutic cycles to establish degree of effectiveness (5). Lately, FDG-PET/CT has been used in different types of neoplasms, breast cancer among them, to establish early response to treatment (6,7). Recent data has established the usefulness of metabolic analysis via FDG-PET, in separating subgroups of chemotherapy. For such analytical approach, sequential estimation of SUVs (Standardized Uptake Value) have been measured along the duration of the treatment. Reduction in SUVs presumes adequate response to treatment (8), while little or no change in metabolic activity presumes sub-optimal response .

However, no definite consensus has been established in regards to what degree of metabolic response is predictive of the desired clinical benefit, particularly early in the treatment . Establishing such criteria could potentially serve as a guideline for monitoring neoadjuvant treatment. Schelling et al, was able to separate a group of patients that eventually showed either progression of the disease or no clinical response as early as the first course of chemotherapy.

The aim of our study is to establish a simple formula using FDG-PET/CT, as early as the first course of chemotherapy, to stratify patients undergoing neoadjuvant chemotherapy for recently diagnosed breast cancer. Those who will benefit from continuing the same treatment will be regarded as responders versus non-responders, which are those in need of changing strategy.

The primary goal of this study is to correlate the results of FDG-PET/CT performed 15 days after the first course of chemotherapy versus those of clinical assessment and breast MRI obtained after the 3rd course of chemotherapy. At that time, a clinical decision on which therapeutic path to be followed will be made.

Monitoring Response After The First Chemotherapy Cycle After Neoadjuvant Breast Cancer Therapy

Monitoring Response After The First Chemotherapy Cycle In Newly Diagnosed Breast Cancer As A Guide For Neoadjuvant Therapy

Sononuclear

Auxilio Mutuo Cancer Center

Hematology-Oncologist

A.M. Nisar Syed, MD

The purpose of this trial is to assess the safety and efficacy of the Xoft Axxent eBx System when used for single-fraction IORT in early stage breast cancer. Hypothesis: IORT using the Xoft Axxent eBx System is no worse (non-inferior) than whole breast irradiation (WBI) when used as stand-alone radiation treatment in breast conserving therapy in women with early stage breast cancer.

Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System®

A Safety and Efficacy Study of Intra-Operative Radiation Therapy (IORT) Using the Xoft® Axxent® eBx® System® at the Time of Breast Conservation Surgery for Early Stage Breast Cancer

IBTR is defined as biopsy-proven reappearance of cancer in the treated breast. IBTR will be assessed at Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. A non-inferiority comparison to whole breast irradiation will be made at 5 years.

Regional breast tumor recurrence is defined as biopsy-proven reappearance of cancer in the axilla. Regional recurrence will be assessed at Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. Regional recurrence rates will be compared to the historical control of WBI at 5 and 10 years.

Disease free survival (DFS) is defined as the length of time from IORT to any first recurrence. The incidence of disease free survival will be assessed at Month 1, Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. DFS will be compared to the historical control at 5 and 10 years.

Cosmetic outcome will be recorded at baseline, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. a. Physician evaluation will be done using the Harvard Scale.

Quality of Life will be assessed at baseline and at each follow-up visit: Month 1, Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. QOL will be measured using the FACT-B self-reporting questionnaires.

The rates and severity of Adverse Events (AEs), Adverse Device Effects (ADEs), and Unanticipated Adverse Device Effects (UADEs) during and following IORT will be assessed at each follow-up visit. Safety events will be compared to the historical control of WBI at 5 and 10 years. Each event will be classified according to the following: Device Related, Procedure Related or Radiation Related.

IBTR is defined as biopsy-proven reappearance of cancer in the treated breast. IBTR will be assessed at Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. A non-inferiority comparison to whole breast irradiation will be made at 10 years.

No interventions are realized, only observational study

None intervention

A prospective observational longitudinal study of 464 patients was performed between 2010 and 2015. Patients with invasive ductal carcinoma (IDC) and ductal carcinoma in situ associated to invasive ductal carcinoma (DCIS +IDC) were included and analyzed.

Type of study:

A prospective observational longitudinal study was performed on patients who had undergone curative surgery for primary invasive breast cancer between 2010 and 2015. The study was performed in a single breast pathology unit \[Alt Penedés hospital and Sant Camil hospital(GAP)\]. Only patients with a definitive histopathology-based diagnostic of ductal carcinoma were included. Patients diagnosed with metastasis were excluded. Patients with bilateral breast cancer were included as two independent study cases.

Patients:

Sample size calculation: 191. A total of 464 patients were included in the study. IDC was present in 221 patients (47.6%) and IDC + DCIS was present in 243 patients (52.4%).

Data collected included clinical characteristics (age, laterality and clinical symptoms at the time of diagnostic), histopathological information (tumor size, tumor grade, hormone receptors, nodal status, HER-2 mutation (erb-b2 receptor tyrosine kinase 2), number of ki67, presence and percentage of DCIS, grade of DCIS, and surrogate subtype) and surgical procedure performed.

Tumor histopathology and the number of lymph nodes involved were evaluated by routine hematoxylin-eosin (H\&E) staining. The histological response to chemotherapy was assessed according to Miller-Payne criteria of grading (MPG) and Residual Disease in Breast and Nodes (RDBN).

The percentage of DCIS and its grade (classified as low, intermediate or high) was measured by two independent pathologists.

Statistical analysis:

Quantitative data are shown as the median or mean of values and their variability is expressed as the range or standard deviation (SD), as specified for each analysis. Qualitative data are shown as absolute values or percentages. The incidence was used as a measure of frequency and the relative risk as a measure of association between independent groups.

The study of the normality of quantitative variables was done applying the Kolmogorov-Smirnov or the Shapiro-Wilk tests, as indicated for each analysis. For significance assessment of quantitative data, unpaired Student's T-test or two-tailed Mann-Whitney U test was applied, as specified for each analysis. For significance assessment of qualitative data, Fisher's exact test or Chi-squared test was applied. For the analysis of more than two groups, one-way ANOVA and Tukey's range test for post hoc pairwise comparison of groups, or Kruskal-Wallis were used. Survival was analyzed with the Kaplan-Meier estimate and survival distributions compared with the Log-Rank test. Multivariate Cox proportional hazards regression model was used to simultaneously evaluate the effect of several factors on survival and mortality.

Statistical analysis was performed using the software SPSS® (Statistical Package for the Social Sciences) version 21.

The aim of the investigator's study is to compare the clinical and histopathological factors between patients with IDC or DCIS-associated IDC (IDC + DCIS) and find the prognostic factors associated to recurrence and mortality in each group.

Study of the Influence of Ductal Carcinoma in Situ on the Outcome of Invasive Breast Cancer

Longitudinal Observational Study About the Influence of Ductal Carcinoma in Situ on the Outcome of Invasive Breast Cancer

Neoplasm metastasis, either local or distant recurrence of the invasive ductal carcinoma

Omphis Foundation

Specialists in General Surgery

Central Nervous System Depressants

All Drugs and Chemicals

Antipyretics

Analgesics

Anesthetics

Acetaminophen

Anesthetics, Local

Participants in this arm will receive cryoablation of their breast tumor two weeks before their routine lumpectomy. They will undergo two blood draws: one before cryoablation (at the time of consent) and one after cryoablation (at the time of surgery).

Participants in this arm will undergo a blood draw at the time of consent and then will continue with their scheduled lumpectomy (standard of care).

Cryoablation is a non-surgical, minimally invasive freezing procedure used to destroy tumors. In the breast, cryoablation is performed under ultrasound guidance. Due to the analgesic properties of freezing, no IV sedation or anesthesia is required. After administration of local anesthetic, the physician makes a 2-3 mm incision and inserts needle-like cryoprobes into the tumor, commencing a number of freeze-thaw cycles. Then the probe is removed, pressure is applied to the area, and a bandage is placed. The patient leaves the office without stitches and minimal, if any, pain. Any residual pain after the procedure is routinely treated with over the counter analgesics such as acetaminophen.

Cryoablation

Cesar Santa-Maria, MD

This study will investigate the safety, feasibility, and immune response associated with cryoablation of early invasive breast cancer prior to lumpectomy. Based on mouse models, the investigators believe that cryoablation will initiate a stronger immune response relative to the control group.

Consenting patients will be randomized to one of two arms: standard of care (control) or cryoablation (intervention). Participants will undergo a blood draw at the time of consent. Those in the control arm will continue with their standard of care lumpectomy. The intervention arm will receive cryoablation 2 weeks before their scheduled lumpectomy and undergo a second blood draw before the lumpectomy.

Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer

Assessed via phone call with participant and including any participant-reported adverse events, such as pain, bruising, bleeding, swelling, and skin changes

Immunohistochemical analysis of biomarkers in blood and resected tissue

Change in appearance based on distortion and volume loss of the breast

Assessment of whether excised tumor's margins are positive or negative for cancer, and whether re-excision is required

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Behaviors and Mental Disorders

Cognitive Dysfunction

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Hormones

any stage of breast cancer without brain metastasis, will undergo hormonal therapy without chemotherapy

any stage of breast cancer without brain metastasis, will undergo chemotherapy and hormonal therapy

any stage of breast cancer without brain metastasis, has undergone surgery prior to screening, will undergo chemotherapy without hormonal therapy

any stage of breast cancer without brain metastasis, will not undergo chemotherapy or hormonal therapy; may undergo radiation therapy or have no therapy

Lei Wang, PhD

The purpose of this study is to improve our understanding of potential changes in size, shape and activity in some brain areas that can occur in women receiving different types of Breast Cancer therapy, and how these changes are related to the development of mild cognitive impairment as the result of these treatments.

This study aims to identify neuroimaging biomarkers for predicting mild cognitive impairment (MCI) in breast cancer patients receiving adjuvant chemo and/or hormonal therapy by examining hippocampal-cortical neurocircuitry. Adjuvant therapies increase long-term survival, but produce changes in cognitive function in 30% (up to 70%) of women on average with breast cancer. Cognitive decline negatively impacts quality of life in patients and their supporters. Therefore, early identification of patients at risk for developing treatment-related cognitive impairment is needed to develop potential prevention or treatment options and prevent further decline. Our recent work demonstrates that patients receiving adjuvant hormonal treatment exhibit decline in cognition as soon as three months post treatment. Although neuroimaging studies have identified brain changes associated with chemotherapy ("chemo brain", no investigation has assessed the type and severity of such changes following hormonal therapy, nor has any study determined which individuals are at greatest risk for cognitive impairment.

Our central hypothesis is that measures of the hippocampal-cortical integrity can be used to predict cognitive decline, and changes of specific domains of cognitive performance in patients receiving adjuvant therapy over time will be related to changes in specific components of this circuitry over time.

Mild Cognitive Impairment in Breast Cancer Patients

Hippocampal Predictors of Cognitive Impairment (HippoPCI) in Breast Cancer Patients

Measured using a neuropsychological test battery

National Institute of Nursing Research (NINR)

Northwestern University

Associate Professor

Antineoplastic Agents

Etanidazole

Single arm study analyzing tumor hypoxia after EF5 injection

An infusion of EF5, a fluorinated 2-nitroimidazole, will be administered using the recommended dose of 21mg/kg one day prior to surgical procedure.

A small tissue sample will be removed from the excised tissue and will be stored for later analysis.

Partial or Total Mastectomy

Mark W Dewhirst, DVM, PhD

The purpose of this pilot study is to determine the prevalence of markers of chronic and cycling hypoxia and reactive species stress (oxidative and nitrosative) in the breast cancer tumor microenvironment. The study is based around four cornerstone features of the pathologic microenvironment - Hypoxia, Reactive Species (reactive oxygen and nitrogen species), HIF-1 and VEGF, which we term the HRHV axis. Fifty breast cancer patients with planned surgical excision will be administered the hypoxia marker drug, EF5, 24-36 hr prior to surgical excision. EF5 is a non-therapeutic drug and provides no direct benefit to those patients enrolled in this pilot study. Tissues obtained intra-operatively will be snap frozen and subsequently analyzed for EF5 binding. Immunohistochemical analysis of a cohort of immunohistochemical and urine markers that depict the HRHV axis will be examined. The association of the markers with the presence of hypoxia, as determined by EF5 positivity, will be determined. Data from this pilot study will be used to establish the prevalence of markers of the HRHV axis in breast cancer. This information will be crucial for future human trials in which the HRHV axis is therapeutically targeted.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fast Spectral Imaging Device for Tumor Margin Mapping	NCT01107080	Breast Cancer		18 Years -	Duke University
An Efficacy Study of the Xoft® Axxent® eBx® IORT System® "Lite"	NCT04349111	Invasive Ductal... Ductal Carcinom...	Intra-operative...	40 Years -	Xoft, Inc.
IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry	NCT03536897	Breast Cancer	IORT	65 Years -	Mount Carmel Health System
Monitoring Response After The First Chemotherapy Cycle After Neoadjuvant Breast Cancer Therapy	NCT01038258	Invasive Ductal... Lobular Breast ... Inflammatory Br...	PET scan after ...	18 Years -	Auxilio Mutuo Cancer Center
Fast Spectral Imaging Device for Tumor Margin Mapping	NCT01107080	Breast Cancer		18 Years -	Duke University
Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System®	NCT01644669	Invasive Ductal... Ductal Carcinom...	Intra-operative...	40 Years -	Xoft, Inc.
Study of the Influence of Ductal Carcinoma in Situ on the Outcome of Invasive Breast Cancer	NCT03669952	Outcome of Brea...	None interventi...	-	Omphis Foundation
Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer	NCT03523299	Invasive Ductal...	Cryoablation	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Monitoring Response After The First Chemotherapy Cycle After Neoadjuvant Breast Cancer Therapy	NCT01038258	Invasive Ductal... Lobular Breast ... Inflammatory Br...	PET scan after ...	18 Years -	Auxilio Mutuo Cancer Center
Mild Cognitive Impairment in Breast Cancer Patients	NCT01949376	Breast Cancer Cognitive Impai...		40 Years - 70 Years	Northwestern University
An Efficacy Study of the Xoft® Axxent® eBx® IORT System® "Lite"	NCT04349111	Invasive Ductal... Ductal Carcinom...	Intra-operative...	40 Years -	Xoft, Inc.
To Evaluate the Characteristics of a Breast Cancer	NCT01055678	Breast Cancer	EF5 Partial or Tota...	18 Years -	Duke University
Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer	NCT03523299	Invasive Ductal...	Cryoablation	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Spots Global Cancer Trial Database for invasive ductal carcinoma