Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Wounds and Injuries

Breast Neoplasms

Hyperthermia

Fever

Breast Diseases

Skin Diseases

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Anti-Bacterial Agents

Doxorubicin

Liposomal doxorubicin

Epirubicin

Antibiotics, Antitubercular

Immunologic Factors

Alkylating Agents

Antineoplastic Agents, Alkylating

Enzyme Inhibitors

Preoperative Anthracycline Doxorubicin 60mg/m2 (or Epirubicin 100 mg/m2) + Standard of Care chemotherapy and drugs + Thermotherapy. Thermotherapy at first 3 chemotherapy treatments for Anthracycline chemotherapy nominally every 21±7 days plus Standard of Care chemotherapy.

Preoperative Anthracycline Doxorubicin 60mg/m2 (or Epirubicin 100 mg/m2) + Standard of Care chemotherapy and drugs

Anthracycline Doxorubicin 60mg/m2 (or Epirubicin 100 mg/m2) + Standard of Care chemotherapy and drugs + Thermotherapy. Thermotherapy at first 3 chemotherapy treatments for Anthracycline chemotherapy nominally every 21±7 days plus Standard of Care chemotherapy. (A targeted tumor temperature of 44ºC (plus or minus 1.5ºC) and a targeted thermal dose of 80 equivalent treatment minutes (plus or minus 20 treatment minutes)). In the event that the targeted minimum cumulative thermal dose of 180 equivalent treatment minutes is not achieved in the first three treatments, an optional fourth thermotherapy treatment may be administered in combination with the fourth course of Anthracycline and standard of care chemotherapy. Standard of care (including breast imaging, drugs, and radiation) will be provided to all eligible subjects during and following the above study treatments.

Focused Microwave Thermotherapy

Anthracycline Doxorubicin 60mg/m2 (or Epirubicin 100 mg/m2) + Standard of Care chemotherapy and drugs. Anthracycline chemotherapy nominally every 21±7 days. Standard of care (including breast imaging, drugs, and radiation) will be provided to all eligible subjects during and following the above study treatments.

Chemotherapy (control)

Deborah Moorad-Watts

William C Dooley, MD

John R Keyserlingk, MD

William C. Dooley, MD

John Keyserlingk, MD

The purpose of this randomized Phase III study is to determine whether preoperative focused microwave heat treatment and chemotherapy combined are more effective than preoperative chemotherapy alone in the treatment of large breast cancer tumors in the intact breast. Combining heat with chemotherapy before surgery might shrink the tumor so that it can be removed in a breast conserving surgery (lumpectomy) instead of a mastectomy.

This randomized multicenter Phase III clinical trial is intended to provide histopathological and clinical information on an innovative, minimally-invasive approach (focused microwave thermotherapy) to the preoperative treatment of breast cancer, using a minimally invasive focused microwave phased array device, the Medifocus, Inc. APA 1000 Breast Thermotherapy Treatment System (heat treatment). Subjects with large primary operable breast cancer, in the intact breast, with clinical tumor size greater than or equal to 3.5 cm (including tumor classification T2 or T3), clinically node negative N0 or node positive (N1 or N2) with distant metastasis (M1) or without distant metastasis (M0) will be randomized (ratio 1:1) to receive (1) preoperative thermotherapy combined with preoperative anthracycline-based combination chemotherapy and standard of care versus (2) preoperative anthracycline-based combination chemotherapy and standard of care alone. The anthracycline-based regimen will be limited to those of the current National Comprehensive Cancer Network (NCCN) guidelines for dose/drug/schedule at the time of patient enrollment. In both arms of the study, standard of care including breast imaging, drugs, and radiation therapy will be provided to all eligible subjects during and following the preoperative regimen. At the clinical discretion of the treating physician, subjects that are estrogen-receptor positive may receive Tamoxifen therapy the day following the completion of chemotherapy. Radiation therapy to the breast tissues and lymph nodes will be given as part of the standard of care for eligible subjects. Treatment Arm I (new arm) regimen includes three preoperative thermotherapy treatments at intervals corresponding to the first three cycles of anthracycline-based combination chemotherapy plus standard of care. The addition of preoperative thermotherapy to preoperative anthracycline-based combination chemotherapy may improve the tumor response rate in terms of shrinkage (the primary endpoint) and may increase the option to perform breast conservation (a secondary endpoint) compared to that achieved with preoperative anthracycline-based combination chemotherapy and standard of care alone. Note: Since there is no consensus combination drug regimen for neoadjuvant treatment of large breast cancer tumors, each study site will use its own standard of care which will include other chemotherapy/drug agents commonly used in combination with an anthracycline (Doxorubicin (trade name Adriamycin) or Epirubicin (trade name Ellence)), which is the study base drug type.

The rationale for including patients that have distant metastasis (M1) at enrollment in this study is as follows. Traditionally, patients with stage IV (metastatic) breast cancer and an intact primary breast tumor have been treated with chemotherapy and radiation for palliation of symptoms, because this metastatic condition is considered to be an incurable disease. In some cases, surgery has been considered for stage IV patients with large, symptomatic breast lesions to control local wound complications and to improve quality of life. However, four recent retrospective peer-reviewed studies have suggested that removing the primary tumor may lead to an improvement in overall survival.

The investigator or designee will fully explain the nature of the study to the subject, along with the aims, methods, anticipated benefits, potential hazards and discomfort that participation might entail. After the nature of the study has been explained and all the subject's questions have been answered, and if the subject agrees to participate in the study, the informed consent will be reviewed and signed by the subject.

Each subject will be treated by thermochemotherapy (new arm) or chemotherapy alone (control arm) and followed for 90 days after surgery during the study. Patients will be followed annually as practiced as standard of care by each participating institution - patients will be followed for tumor recurrence and future medical intervention related to the patient's breast cancer.

Thermotherapy is administered in an out-patient setting. During thermotherapy which is completed in approximately 60 minutes or less, the patient is treated in the prone position on a treatment bed. After administering a local anesthetic, to guide the treatment a minimally invasive combination microwave/temperature probe is placed in the tumor under ultrasound guidance. The thermotherapy treatment is adjusted in accordance with patient comfort.

Anthracycline-based chemotherapy will be administered in accordance with standard preoperative chemotherapy delivery at each study center - the number of chemotherapy cycles and cycle timing may vary in this study. Each study center will be using anthracycline (Doxorubicin or Epidoxorubicin) as the base chemotherapy agent and the other chemotherapy agents and drugs will vary depending on the study center and subject specific needs. Each cycle of Doxorubicin at 60 mg/m2 for four cycles or Epidoxorubicin at 100 mg/m2 for 6 cycles and combination Standard of Care chemotherapy will be administered nominally every 21 (plus or minues 7) days. The timing between cycles of anthracycline can be subject specific at the physician's discretion, but in no case will anthracycline be administered with a cycle timing of less than seven (7) days between anthracycline cycles. A thermotherapy session will be administered on the same day as the administration of the first, second, and third cycle of preoperative Doxorubicin or Epidoxorubicin chemotherapy. Chemotherapy will be administered and then the subject will receive thermotherapy. (If the thermotherapy session cannot be administered on the same day as Doxorubicin or Epidoxorubicin chemotherapy it will be administered as soon as possible the following day but no later than 36 hours post Doxorubicin or Epidoxorubicin chemotherapy. The remaining cycle(s) of chemotherapy will then be administered without thermotherapy. If the desired cumulative minimum thermal dose is achieved in the first three thermotherapy treatments, the remaining cycle(s) of chemotherapy will then be administered without thermotherapy. If the desired cumulative minimum thermal dose is not achieved during the first three preoperative Doxorubicin or Epidoxorubicin chemotherapy cycles, thermotherapy will be administered with the fourth cycle of preoperative chemotherapy. If the subject cannot tolerate more than one or two thermotherapy treatments, the subject will continue in the study on the remaining cycles of chemotherapy. If the subject has clinically progressive disease, the thermo-chemotherapy treatment will be discontinued and the subject will receive the remaining cycles of chemotherapy preoperatively or postoperatively (as standard care).

At the end of the course of thermo-chemotherapy or chemotherapy alone, and following all pre-surgery evaluations, the surgeon and subject will make decisions on the extent of surgery to be performed. These decisions will be made on the basis of surgical and institutional standards, and those of the National Comprehensive Cancer Network (NCCN) Breast Cancer Treatment Guidelines. Subjects will undergo mastectomy or breast-conserving surgery. It is understood that some subjects will select mastectomy for treatment even when the surgeon recommends breast conservation. The surgeon shall document the reasons why either mastectomy or breast conservation was selected.

The subject will undergo clinical exam and imaging of the breast to measure tumor size, the day prior to or the day of the lumpectomy or mastectomy. Any additional imaging will be at the discretion of the physician. At the discretion of the physician, an optional core biopsy of the tumor will be taken the day prior or the day of the surgery.

Following surgery, pathology will be performed on the excised breast tumor tissue to determine tumor cell death. For breast conservation, the breast must be of sufficient size to allow adequate tumor removal with a satisfactory cosmetic result. The objective of surgery is to obtain local control of the breast cancer with the best cosmetic result possible. A breast conservation surgery procedure requires excision of the tumor and margins without removal of more normal breast tissue than is required to achieve negative margins. Pathologic evaluation of the excised tissue will determine whether the margins are negative or positive. For subjects with involved margins following breast conservation surgery, if the breast will tolerate it, the subject may undergo one or more further segmental resections in order to achieve clear margins.

Randomized Study of Combination Chemotherapy With or Without Focused Microwave Thermotherapy Before Surgery in Treating Women With Large Breast Cancer Tumors

Randomized Pivotal Trial to Assess the Safety and Efficacy of Preoperative Focused Microwave Thermotherapy Plus Preoperative Chemotherapy Versus Preoperative Chemotherapy Alone for Cytoreduction of Large Breast Cancer in Female Patients With Intact Breast

Evaluate the efficiency of preoperative focused microwave thermotherapy as an adjunct to chemotherapy to increase the ultrasound-measured absolute mean tumor percent shrinkage by volume over that achieved by SOC preoperative chemotherapy.

Evaluate the potential benefits of this combination treatment to increase the absolute rate for which the surgeon can recommend breast conservation (lumpectomy or partial mastectomy) over that achieved using standard of care preoperative chemotherapy alone.

Evaluate the potential benefits of this combination treatment to increase the clinical (caliper-measured) absolute mean tumor shrinkage by area over that achieved by SOC preoperative chemotherapy

Evaluate the potential benefits of the combination treatment to increase the absolute mean tumor shrinkage by area on mammography over the achieved by SOC preoperative chemotherapy

Evaluate the potential benefits of this combination treatment to increase the absolute mean tumor shrinkage by volume based on magnetic resonance imaging (MRI) over that achieved by SOC preoperative chemotherapy.

Evaluate the potential benefits of this combination treatment to increase the absolute mean percent localized pathologic tumor cell kill by volume over that achieved by SOC preoperative chemotherapy.

Medifocus, Inc.

Pathologic Complete Response

Disease Progression

Disease Attributes

Omit breast radiation for 3 years after surgery

Omit breast radiation

Armando Giuliano, MD, FACS, FRCSEd

The purpose of this study is to evaluate the feasibility, based on recruitment rate over a 3-year period, of enrolling patients for the omission of post-operative breast radiation following breast conserving surgery and sentinel node biopsy or axillary lymph node dissection in women with HER2+ breast cancer who achieve pathologic complete response.

Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic Complete Response

Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic

Measured by the number of recruited patients over the number of patients approached to participate to the trial. Feasibility will be defined as recruitment rate of greater or equal to 25% among patients who are eligible to participate in the trial.

Armando Giuliano

Chief, Surgical Oncology

After partial mastectomy, patients will be subject to intraoperative randomization to the shave margin group where additional tissue will be resected.

After partial mastectomy, patients will be subject to intraoperative randomization to the no shave margin group, where after initial surgery, no further tissue will be removed.

For the shave group, additional superior, inferior, medial and lateral margins will be removed, oriented, and sent for pathologic evaluation at the local site. Resection of additional anterior and posterior margins will be left to surgeon discretion, as this will depend on if skin or fascia was taken. All surgeons participating in the study will be educated on the expectation of what is considered a "shave margin". A shave margin is defined as an additional segment of breast tissue taken from each of the superior, inferior, medial, and lateral aspects of the cavity, such that the entire circumference of the cavity is re-excised following this procedure. Orientation of each shaved margin will be done to mark the true margin.

Partial mastectomy plus additional Shave Margin

Surgeons will be instructed to close after partial mastectomy with no further excision.

Partial mastectomy

Anees Chagpar, MD

Breast cancer is the most common malignancy affecting women in the US. Surgical management is the mainstay of therapy, and in general consists of resection of the primary tumor with either a partial mastectomy (aka "lumpectomy") or a total mastectomy.

The investigators hypothesize that routine shave margins during partial mastectomy will significantly reduce positive margin rate. A positive margin means that cancerous cells were detected at the edge of the excised area. This generally mandates a return to the operating room for re-excision.

Some authors have investigated, in a retrospective fashion, the use of routine shave margins, where surgeons routinely take additional margins at the time of the initial partial mastectomy as a means of obtaining negative margins. While these retrospective studies have found that positive margin rates declined using this technique, opponents to this technique wonder if this truly results in a higher negative margin rate without compromising cosmesis or increasing tissue volume removed. As these studies were retrospective, it was possible that the initial resection was smaller than what those who do not routinely take shave margins would resect. No one had evaluated the impact of further resection on operative time, nor in a blinded fashion, evaluated cosmesis. Further, there had yet to be a prospective study to evaluate the impact of this on local recurrence rates. Hence, the investigators performed a prospective randomized controlled trial of this technique at Yale. The data from this study, published in the New England Journal of Medicine, found that the technique cut positive margin and re-excision rates in half. Some wondered, however, about the external generalizability of these findings, particularly in non-academic settings. Hence, a multicenter trial to validate these findings is warranted.

Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients

A Multicenter Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients

The effect is positive margin rate post-surgery as measured by local pathological reports. Positive margins were defined as tumor touching the edge of the specimen that was removed in patients with invasive cancer and tumor that was within 2 mm of the edge of the specimen removed in those with ductal carcinoma in situ.

Patients will be assessed for local recurrence based on physical examination, mammography, and follow up phone calls. This is a composite score with only one outcome and only one unit (respondents). A positive results from any of these methods indicates recurrence.

Subjects will be asked their perception of physical appearance: poor, fair, good, or excellent.

based on the sum of the volumes of tissue excised as found in the gross description of the specimens on the pathology report.

Quality of Life Questionnaire measures quality of life over the past 7 days and includes 75 questions that are answered on a Likert scale. Questions assess physical, social, emotional and functional well-being in addition to cosmetic and physical appearance and questions regarding the surgery. Higher scores indicate a higher quality of life.

Yale University

30 patients undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled to assess the ideal pressure that should be applied when taking optical measurements.

40 patients undergoing lumpectomy or mastectomy will be enrolled to assess the random and systematic errors of the miniature spectral imaging system.

150 patient undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled in order to determine the sensitivity and specificity of the miniature spectral imaging system.

miniature spectral imaging system

Bench-top optical spectrometer

High resolution microendoscope

Nimmi Ramanujam, Ph.D.

The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens.

The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. We are seeking to establish the accuracy of first and second-generation prototypes of technologies utilizing optical spectroscopy for intra operative margin assessment in partial mastectomy or mastectomy specimens. The aims associated with this research are as follows, (1) to evaluate the device-tissue interface on reduction mammoplasty specimens from a total of 20 patients, (2) to assess random and systematic errors of the new miniature system on mastectomy specimens from a total of 40 patients (3) to test the sensitivity, and specificity of the miniature spectral imaging system for margin assessment on excised partial mastectomy or mastectomy specimens from a total of 150 patients undergoing breast conserving surgery.

Last patient's surgery took place in 2017 and recruitment remained open. Later the team encountered staffing issues; therefore the study status was updated to suspended. We recently made the decision to no longer attempt to enroll the remaining 2 subjects and focus on the data analysis only.

A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins

National Institutes of Health (NIH)

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Duke University

Neoplasm Metastasis

Central Nervous System Depressants

Anesthetics

Patient receives an ultrasound of lymph nodes at diagnosis and on the day of surgery. Marker clip(s) placed using a needle in the abnormal lymph node(s). If patient received chemotherapy before surgery, fine needle aspiration (FNA) performed of any abnormal lymph nodes either right before or during standard breast and underarm surgery. To perform FNA, area is numbed with anesthetic and a needle is inserted into the affected area so that cells can be collected. Standard breast and underarm surgery (underarm lymph node removal and either a partial mastectomy or total mastectomy with or without reconstruction) performed.

If patient received chemotherapy before surgery, fine needle aspiration (FNA) performed of any abnormal lymph nodes either right before or during standard breast and underarm surgery. To perform FNA, area is numbed with anesthetic and a needle is inserted into the affected area so that cells can be collected.

Fine Needle Aspiration (FNA)

Patient receives an ultrasound of lymph nodes at diagnosis and on the day of surgery. Marker clip(s) placed using a needle in the abnormal lymph node(s).

Ultrasound

Patient receives standard breast and underarm surgery (underarm lymph node removal and either a partial mastectomy or total mastectomy with or without reconstruction).

Breast Surgery + Lymph Node Removal

Henry Kuerer, MD,PHD

The goal of this clinical research study is to learn if it is feasible to use find (using ultrasound) and surgically remove cancer that has spread to the lymph nodes, during routine lymph node surgery.

In standard care, all affected lymph nodes are removed. In this study, however, the cancerous lymph nodes will be removed separately and then the rest of the lymph nodes under the arm will be removed after that.

Before surgery, patient may or may not receive the standard chemotherapy drug(s) that their doctor recommends. If patient's doctor suggests chemotherapy before surgery, they will be asked to sign a separate consent form that describes the chemotherapy and its risks.

On the day of surgery, patient will have an ultrasound of their lymph nodes. If patient has received chemotherapy before their surgery, they will have a fine needle aspiration (FNA) of any abnormal lymph nodes either right before or during their standard breast and underarm surgery. The abnormal lymph nodes will be marked for the surgeon to remove using standard techniques with either ultrasound, a mammogram, or 125I-seed placement. To perform an FNA, the area is numbed with anesthetic and a needle is inserted into the affected area so that cells can be collected. Ultrasound imaging is used to guide the needle into the area. The cells will be used for research to learn if the chemotherapy killed the abnormal lymph node cells.

Patient will have standard breast and underarm surgery (underarm lymph node removal and either a partial mastectomy or total mastectomy with or without reconstruction). Patient's doctor will discuss the surgery with patient in more detail and patient will be asked to sign a separate consent form.

During this surgery, the 1 or 2 abnormal underarm lymph nodes found by ultrasound will be removed and sent as separate samples before the rest of the underarm lymph nodes are removed.

Patient's study participation will be complete after surgery.

This is an investigational study. The surgery in this study is standard treatment. It is investigational to remove the abnormal lymph nodes before the rest of the underarm lymph nodes are removed. In this study, the exact same number of lymph nodes would be removed as is standard, but the surgery is being done in a 2-step process.

Up to 12 patients will take part in this study. All will be enrolled at MD Anderson.

Selective Image Guided Resection of Axillary Lymph Nodes

Feasibility of Selective Image Guided Resection of Cytologically Documented Axillary Lymph Node Metastases

Patients required to have a minimum of at least two nodal ultrasounds: once at diagnosis and once prior to surgery. Marker clip placed in the one or two abnormal node(s) at diagnosis and on day of surgery. Nodes localized by ultrasound (or by mammographic or 125I-seed localization if not visualized well with ultrasound) for excision, and fine needle aspiration (FNA) repeated of previous abnormal nodes. Patients undergo standard breast and axillary surgery. During surgery the one or two abnormal axillary nodes identified by ultrasound are removed. The lymph nodes excised with the clip will be evaluated with specimen x-ray. If no marker clip is identified in the lymph node(s), the axillary contents will be x-rayed to document removal of the marker clip. Procedure considered a success if all marker clips are successfully identified in the preoperative ultrasound and documented in a lymph node via postoperative specimen x-ray of the excised material.

Secondary objective defined as determination of whether the excised node contains metastases or not (defined as a lymph node with a metastasis greater than 0.2 mm in greatest dimension identified by H\&E staining) and recording the presence or absence of residual metastases by repeat fine needle aspiration (FNA) at the time of surgery.

M.D. Anderson Cancer Center

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

* Brachytherapy TRI-APBI the PTV is prescribed 7.5 Gy x three fractions given over two to three days OR
* External beam TRI-APBI the PTV is prescribed 8.5 Gy x three fractions given over two to three days

* TRI-APBI simulation must take place no more than 8 weeks from final definitive breast surgery
* Machines that could be used include: SAVI applicator, The ViewRay System for Radiation Therapy, The ViewRay (MRIdian) Linac System, Halcyon, True Beam, True Beam STx, Edge Radiotherapy Delivery System

Three Fraction Accelerated Partial Breast Irradiation

Imran Zoberi, M.D.

The investigators proposed approach allows them to deliver a low total dose of radiation to patients with low-risk, early-stage breast cancer which would further minimize the impact of adjuvant therapy. This work has the potential to revolutionize partial breast irradiation by allowing it to take place at many radiation oncology centers with minimal specialized equipment beyond that commonly available. The investigators first step is this proposed single institution phase I/II study designed primarily to evaluate the tolerance of this approach which the investigators are choosing to call Three Fraction APBI (Tri-APBI).

Three Fraction Accelerated Partial Breast Irradiation as the Sole Method of Radiation Therapy for Low-risk Stage 0 and I Breast Carcinoma

Evaluation of Three Fraction Accelerated Partial Breast Irradiation as the Sole Method of Radiation Therapy for Low-risk Stage 0 and I Breast Carcinoma

* Adverse events will be graded using CTCAE Version 5.0
* Toxicities of concern include breast pain, delayed wound healing, persistent seroma fluid accumulation, breast fibrosis, and fat necrosis in the treated breast. Rare toxicities include radiation pneumonitis, coronary artery disease, and pericarditis

-Recurrence of breast cancer in the treated breast is an ipsilateral breast tumor recurrence (IBTR)

-Defined as ipsilateral axilla, infraclavicular, supraclavicular, and internal mammary groups

The QLQ-C30 includes 6 general questions and 24 questions in 9 subscales measuring physical, role, emotional, cognitive and social function, as well as global health status, nausea/ vomiting, pain and fatigue

* Each of the subscales will be tabulated and presented graphically over the assessment times. Mixed repeated measures models will be generated to describe the nature of change in quality of life over time
* Responses vary from 1=Not at All to 4 = Very Much

* The QLQ-B23 provides 23 questions in 8 breast cancer specific subscales, 4 measuring symptoms and 4 measuring function
* Each of the subscales will be tabulated and presented graphically over the assessment times. Mixed repeated measures models will be generated to describe the nature of change in quality of life over time
* Responses vary from 1=Not at All to 4 = Very Much

* Cosmesis will be graded by the patient and the radiation oncologist (or nurse practitioner) before treatment, 6-10 weeks after TRI-APBI, at 4-8 month follow-up, at 10-14 month follow-up, and at yearly intervals thereafter for a total of 5 years following TRI-APBI
* The Breast Retraction Assessment consists of measuring certain parts of a participant's chest and then using a formula to come up with the measurements

* Cosmesis will be graded by the patient and the radiation oncologist (or nurse practitioner) before treatment, 6-10 weeks after TRI-APBI, at 4-8 month follow-up, at 10-14 month follow-up, and at yearly intervals thereafter for a total of 5 years following TRI-APBI
* The Percent Breast Retraction Assessment consists of measuring certain parts of a participant's chest and then using a formula to come up with the measurements

* Cosmesis will be graded by the patient \& radiation oncologist (or nurse practitioner) before treatment, 6-10 weeks after TRI-APBI, 4-8 month follow-up, 10-14 month follow-up, \& yearly intervals for a total of 5 years following TRI-APBI
* The Aaronson modification of the Harris scale will be used to evaluate cosmesis \& the scale consists of:

  * Excellent-when compared to the untreated breast, there is minimal or no difference in the size, shape or texture of the treated breast - may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance
  * Good-mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape
  * Fair-obvious difference in the size \& shape of the treated breast. This change involves 1/4 or less of the breast
  * Poor-marked change in the appearance of the treated breast involving more than 1/4 of the breast tissue

Washington University School of Medicine

Carcinoma in Situ

Carcinoma, Ductal

Carcinoma, Intraductal, Noninfiltrating

Adenocarcinoma

Breast Carcinoma In Situ

28.5 Gy delivered in 5 daily fractions then 4-12 weeks post NIBB, surgery via partial mastectomy

NIBB: accuboost

Jaroslaw Hepel, MD

Partial breast irradiation is typically performed after surgical removal of the tumor. Partial breast irradiation allows for focused radiation to the area from which the cancer was removed, sparing breast tissue from the potential bad effects of radiation compared to radiating the whole breast, which was the standard of care for many years. This study is evaluating the use of partial breast irradiation with NIBB performed before surgery instead of after surgery.This should allow researchers to target the cancer even more accurately and result in less normal breast tissue receiving radiation which may cause less side effects and/or a better cosmetic outcome.

In this study partial breast treatment will be given with NIBB in 5 treatments over about 1 week. Surgical removal of the tumor will then be performed between 4-12 weeks following radiation treatment. Researchers believe that participant's risk of complications from surgery will not be higher after getting these radiation treatments than it would have been if participants had surgery first, but that is one of the things researchers are studying.

This study is specifically enrolling female patients with breast cancer age 60 or older.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Randomized Study of Combination Chemotherapy With or Without Focused Microwave Thermotherapy Before Surgery in Treating Women With Large Breast Cancer Tumors	NCT01204801	Breast Cancer	Focused Microwa... Chemotherapy (c...	18 Years -	Medifocus, Inc.
Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic Complete Response	NCT05371860	Breast Cancer HER2-positive B...	Omit breast rad...	40 Years -	Cedars-Sinai Medical Center
Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients	NCT02772731	Breast Cancer	Partial mastect... Partial mastect...	18 Years -	Yale University
Randomized Study of Combination Chemotherapy With or Without Focused Microwave Thermotherapy Before Surgery in Treating Women With Large Breast Cancer Tumors	NCT01204801	Breast Cancer	Focused Microwa... Chemotherapy (c...	18 Years -	Medifocus, Inc.
A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins	NCT01372631	Breast Cancer	miniature spect... Bench-top optic... High resolution...	18 Years -	Duke University
Selective Image Guided Resection of Axillary Lymph Nodes	NCT01880645	Breast Cancer	Fine Needle Asp... Ultrasound Breast Surgery ...	18 Years -	M.D. Anderson Cancer Center
Three Fraction Accelerated Partial Breast Irradiation as the Sole Method of Radiation Therapy for Low-risk Stage 0 and I Breast Carcinoma	NCT03612648	Breast Carcinom... Breast Cancer	Three Fraction ... Partial mastect...	50 Years -	Washington University School of Medicine
BrUOG 351: PRE-OPERATIVE APBI USING NIBB	NCT03437915	Breast Cancer Invasive Breast... Ductal Carcinom...	NIBB: accuboost Partial mastect...	60 Years -	Brown University

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