Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Carcinoma

Breast Neoplasms

Hyperplasia

Carcinoma in Situ

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Breast Carcinoma In Situ

Background:

* X-ray mammography is the standard method for breast cancer screening. It is a noninvasive test using x-rays to take pictures of breast tissue and detect any abnormalities.
* The National Institutes of Health (NIH) Clinical Center has a breast imaging unit that has been accredited by the American College of Radiology. To maintain accreditation, the unit must recruit a certain number of women to have clinical mammograms each year in order to maintain a high level of clinical skills and experience for the radiologists and technologists.

Objectives:

- To create a state-of-the-art mammography unit at the NIH Clinical Center in order to maintain American College of Radiology accreditation of the NIH breast imaging facility.

Eligibility:

- Women who are eligible for breast cancer screening because of family cancer history, genetic test results, or previous instances of cancer. Participants may not be pregnant or nursing at the time of the screening.

Design:

* Participants will provide a brief medical history on arrival at the NIH breast imaging unit.
* Each participant will have a standard mammogram performed by a radiology technician.
* If the study is normal, participants will be told that no further evaluation will be performed. If the results indicate a need for further imaging or tissue biopsy, participants may elect to return to the care of their primary physician or to receive further follow-up at the NIH Clinical Center.

Background:

A mammography facility in the Clinical Center of the National Institutes of Health (NIH) is present in order to facilitate breast cancer research programs. The American College of Radiology mammography accreditation program (1992 mammography Quality Standards Act (MQSA) (1-3)) has established national standards for site accreditation for mammography. A key requirement is to perform a minimum number of mammography examinations in the facility per year. Minimum examination volumes are required to maintain expertise of the facility staff for maintaining facility accreditation and compliance with Food and Drug Administration (FDA) requirements.

Objectives:

Our primary aim is a protocol to maintain accreditation of the NIH breast imaging facility in the Clinical Center of NIH.

Eligibility:

Women who are clinically indicated for screening mammography according to the National Comprehensive Cancer Network (NCCN) guidelines (3) and the American Cancer Society guidelines.

Design:

A standard of care protocol to perform standard clinically indicated mammography exams. We are expected to recruit 1000 patient /year.

X-Ray Mammography Standard of Care Protocol

National Institutes of Health Clinical Center (CC)

* The CESM images will be performed according to clinical protocol
* Images will be acquired within approximately 2-12 minutes of contrast injection
* A total of four images per breast will be acquired with low and high energy
* Two radiologists will prospectively review the CESM, and will use a third as tie-breaker
* The CESM will be evaluated for the biopsy site and up to two additional findings in either breast
* The biopsy site will be evaluated for abnormal findings that would suggest malignant involvement

Contrast enhanced mammography is a new type of mammogram that uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone.

Contrast enhanced mammography

Jordana Phillips, MD

This research study is studying whether contrast enhanced mammography can predict if atypical ductal hyperplasia will progress to cancer.

The device involved in this study is:

-Contrast enhanced mammography

This research study is a Pilot Study, which is the first time investigators are examining this study device for this purpose.

Atypical ductal hyperplasia (ADH) is a common diagnosis after breast biopsy. Although it is not cancer itself, ADH can become breast cancer in some cases. As a result, surgery is performed to remove ADH to make sure it doesn't progress to cancer. In many cases, no cancer is found during the surgery.

Previous studies have shown that breast MRI may be able to predict which areas of ADH will be cancer at the time of surgery. This would help prevent unnecessary surgery in some patients.

Contrast enhanced mammography is a new type of mammogram that is already being used in clinical practice to help find breast cancer. Similar to breast MRI, it uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone. Contrast material is a dye or other substance that helps show abnormal areas within the body.

Studies have shown the contrast enhanced mammography has a similar ability to find breast cancer as breast MRI.

The investigators purpose is to see whether contrast enhanced mammography can predict which areas of ADH will become breast cancer at the time of surgery. The investigators believe this will help prevent unnecessary surgery in many with women with the diagnosis of ADH.

Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical Ductal Hyperplasia

Investigators will evaluate whether enhancement on CESM can predict which cases of ADH upgrade at the time of surgical excision.

Investigators will evaluate how incidental findings seen on CESM impact the surgical management of patients diagnosed with ADH. The initial surgical management documented in the clinical report (created before CESM performed) will be compared with the surgical management documented in the medical record after the CESM was performed to determine the change.

GE Healthcare

Dana-Farber Cancer Institute

Principal Investigator

* The CESM images will be performed according to clinical protocol
* Images will be acquired within approximately 2-12 minutes of contrast injection
* A total of four images per breast will be acquired with low and high energy
* Two radiologists will prospectively review the CESM, and will use a third as tie-breaker
* The CESM will be evaluated for the biopsy site and up to two additional findings in either breast
* The biopsy site will be evaluated for abnormal findings that would suggest malignant involvement

Contrast enhanced mammography: Contrast enhanced mammography is a new type of mammogram that uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone.

Contrast Enhanced Mammography

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Patients who had ADH and were getting surgical excision were enrolled. We terminated the study as recruitment was too low to continue.

Dr Jordana Phillips

Images were performed but outcome data was not collected and therefore we cannot provide any analysis.

CESM's Ability to Predict Upgrade Rates of Biopsy Proven ADH at Surgical Excision

Types of Changes in Surgical Management Based on CESM

Overall Study

Rare Diseases

Cicatrix

Papilloma

Carcinoma, Lobular

Fibroadenoma

Neoplasms, Squamous Cell

Breast Diseases

Skin Diseases

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Phyllodes Tumor of the Breast

Patients will undergo vacuum-assisted percutaneous excision (VAPE). The intervention group will have post-procedure imaging the same day to confirm complete excision.

The intervention group will then have imaging at 6, 12, and 24 months as per the radiology algorithms for following suspicious lesions (BIRADS 3 category). If at any point during the imaging follow up, a suspicious lesion or calcifications are detected, it would be sampled with core needle biopsy and then surgically excised as appropriate.

The intervention group will also be seen in clinic at 1 month with no imaging and then at 6, 12, and 24 months to correspond to the imaging visits.

Patients will undergo standard open surgical excision.

The control group will then have follow up imaging at 12 and 24 months as per the usual radiology algorithms following excision of a lesion. If at any point during the imaging follow up, a suspicious lesion or calcifications are detected, it would be sampled with core needle biopsy and then surgically excised as appropriate.

The control group will also be seen in clinic at 1 month with no imaging and then at 12 and 24 months to correspond to the imaging visits.

The intervention group will undergo the vacuum assisted percutaneous excision (VAPE). All VAPE procedures will be performed on a digital supine table using the ATEC© Breast Biopsy System hand piece (Hologic) with a 9-gauge needle and a 10 or 20 mm aperture providing 6-mmHg of suction strength to completely excise the breast lesion.

Vacuum-assisted percutaneous excision

The control group will undergo standard open surgical excision of the breast lesion. This will be done in the operating room using preoperative image-guided localization with radioactive seed (I-125) or in the procedure room of the Breast Care Centre if appropriate (i.e. lesion is palpable and localization is not required).

Open surgical excision

Muriel Brackstone, PhD, MD

Sarah Knowles, MSc, MD

This randomized controlled trial compares vacuum-assisted percutaneous excision to open standard surgical excision in women who have high-risk or borderline, non-malignant breast lesions with respect to efficacy, safety, cosmesis and patient satisfaction.

In women diagnosed with high-risk or borderline, non-malignant breast lesions, is vacuum-assisted percutaneous excision (VAPE) comparable to open standard surgical excision with respect to efficacy, safety, cosmesis and patient satisfaction?

With the increase in breast imaging for screening there has been corresponding rise in detection of high-risk/borderline, non-malignant breast lesions that require surgical excision to confirm diagnosis and rule out underlying malignancy. Image-guided vacuum-assisted percutaneous excision (VAPE) could offer an alternative to standard open surgical excision for complete excision of these lesions with a possible improvement in patient satisfaction and cosmetic outcomes and decreased complications.

In this single-centre, non-inferiority designed prospective randomized, open label controlled trial, women over 18 years who are found to have a borderline or high-risk, non-malignant breast lesions on core needle biopsy will be considered eligible. Exclusion criteria will be women with a greater than 25% lifetime risk of breast cancer, patients whose pathology and imaging are discordant, and those with extensive calcifications extending over 2cm, a mass larger than 2 cm, or lesions with high-risk features. Informed consent will be obtained and patients will be randomized to standard surgical excision or VAPE. They will then be followed with imaging as appropriate.

The primary outcome measure is the incidence of complete removal of the lesion. The secondary outcome measures are patient satisfaction, cosmetic outcomes and complications such as bleeding and infection.

This trial is the first randomized controlled trial to investigate the role of VAPE compared to standard surgical excision as a means of completely excising borderline or high-risk breast, non-malignant breast lesions. The investigators hypothesize that VAPE will show comparable efficacy and may even have improved safety, cosmesis and patient satisfaction.

Comparing Vacuum-Assisted Percutaneous Excision to Open Surgical Excision for Borderline or High-Risk Breast Lesions

Efficacy, Safety, Cosmesis and Patient Satisfaction With Vacuum-Assisted Percutaneous Excision (VAPE) Compared With Standard Surgical Excision (X) of Non-malignant, Borderline or High-risk Breast Lesions: A Randomized Controlled Trial

As defined by the Center for Disease Control and Prevention (CDC) criteria (Pearson) as infection occurring within the first 30 post-operative days with at least one of the following: (a) purulent drainage from the incision or biopsy site, (b) organisms isolated from an aseptically obtained culture of fluid or tissue, (c) incision is deliberately opened by a surgeon AND patient has at least one of the following signs or symptoms: pain or tenderness, localized swelling, erythema, or heat, or (d) diagnosis of SSI by the surgeon

Any bleeding or hematoma that requires an intervention (such as re-operation to evacuate the hematoma or control the bleeding or aspiration of the hematoma)

No evidence of residual lesion at the time of excision or on follow up imaging exams and no need for further surgical re-excision for residual lesion.

Patient satisfaction as assessed by the BREAST-Q questionnaire for breast conserving therapy, Version 2.0, a validated patient-reported outcome measure that quantifies health-related quality of life and patient satisfaction. It will be completed preoperatively, and at 1, 6, and 12 months postoperatively.

There are three components being assessed:

1. Physical well-being: 10 items scored using a 3-point scale (1=none of the time, 2=some of the time, 3=all of the time).
2. Psychosocial well-being: 10 items scored using a 5-point scale (1=none of the time, 2=a little of the time, 3=some of the time, 4=most of the time, 5=all of the time).
3. Satisfaction with breasts: 4 items scored using a 4-point scale (1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, 4=very satisfied).

Each component has a raw scale summed score (the sum of all the scores for each item) that is converted into a score from 0 (worst) to 100 (best) for analysis.

Cosmesis as assessed by the Modified Harvard-Harris Cosmetic Scale, a validated four-point scale that describes the overall aesthetic appearance of the breasts (categorical scale = excellent, good, fair or poor). It will be administered to both the patients as a self-assessment and the surgeons before the intervention and at various time points postoperatively (1 month, 6 months, and 12 months).

Lawson Health Research Institute

Associate Professor of Surgery & Oncology

Fibrocystic Breast Disease

Amy C Whiffen, MPH

Lisa Held, BA

Rhonda Theodore

Kathie-Ann Joseph, MD, MPH

The purpose of this study is to increase understanding of women who are at high risk for developing breast cancer. Data from this group will be collected and entered into a registry. This registry serves as a clinical database to support research in prevention, early detection and treatment of breast cancer.

This is a longitudinal cohort study that collects data of eligible women at risk for developing breast cancer. Patient information will be entered into a secured computerized database that is used for research on the prevention, early detection and treatment of breast cancer.

Women At Risk: The High Risk Breast Cancer Program

Women At Risk

New York Presbyterian Hospital

Amy Whiffen

Carcinoma, Ductal

Patients in this arm underwent to an initial sequence of sampling (less than 4 g of tissue sampled)

Patients in this arm will undergo a second sequence of biopsy samples (at least 4g sampled)

at least 4g of tissue sampled (excisional biopsy)

Vacuum-assisted excisional biopsy

biopsy with less than 4 g of tissue sampled

Not excisional biopsy

Luca Nicosia, MD

Claudia Sangalli, MSc

The goal of this prospective cohort study is to evaluate the possibility of vacuum-assisted excisional biopsy (VAE) to completely remove the pathology in case of small lesions for Atypical Ductal Hyperplasia (ADH) and low-intermediate grade Ductal Carcinoma in Situ (DCIS).

Surgery is the current standard of care of breast lesions like the Ductal Carcinoma In Situ (DCIS) and the Atypical Ductal Hyperplasia (ADH). However, the survival benefit of surgical resection in patients with such lesions appears to be low, especially for ADH and low-grade DCIS where comorbidity of surgery and prior depression have been reported as important factors related to worse quality of life in these women.

Patients with suspicious breast lesions (BIRADS\>3) who are candidates for vacuum assisted breast biopsy will be prospectively select and enroll if the radiological lesion diameter is less than 15 mm.

The investigators will select those patients in whom after an initial sequence of sampling (12 cores), and will check the complete macroscopic removal of the lesion (with radiograms of the biopsied part of the breast). Those patients (complete macroscopic removal, with real-time verification during the procedure) will be randomized into two groups. A first group of patients will finish the biopsy procedure after the first collection sequence (12 cores, 3 grams of tissue taken and complete macroscopic removal). A second group of patients (randomized subdivision) will undergo a second sequence of biopsy samples (other 4 cores and 1 gram of tissue taken) in the same session: the material collected will be sent separately to the pathologist.

Excisional Vacuum-Assisted Breast Biopsy

Excisional Vacuum-Assisted Breast Biopsy (VAE): Application to Avoid Surgery in Atypical Ductal Hyperplasia and Low/Intermediate Grade Ductal Carcinoma in Situ of the Breast

Comparison of the percentage of patients with a lack of pathology (also in situ) at the surgery between the two groups

Ministero della Salute, Italy

European Institute of Oncology

Precancerous Conditions

Participants will receive ruxolitinib 20 mg by mouth twice daily for 15 days (+/- 5 days). Ruxolitinib will be supplied as four, 5 mg tablets.

Participants will receive a placebo (sugar pill) that is designed to mimic ruxolitinib. The placebo will be supplied as four, 5 mg tablets. Participants assigned to this arm will take four, 5 mg tablets by mouth twice daily for 15 days (+/- 5 days).

Ruxolitinib

Placebo (for Ruxolitinib)

Kristen Otte

Shelley Hill

Catherine Parker, MD

Versie Barnes

Carla Fisher, MD

Anton Lulaj

Sheldon Feldman, MD

Crissey Tait

Kristalyn Gallagher, DO

Clinical Trials Information Program

Ingrid Meszoely, MD

Claudette Foreman

Julie Nangia, M.D.

Mothaffar Rimawi, M.D.

Bora Lim, M.D.

C. Kent Osborne, M.D.

Diane Weber, RN

Parijatham Thomas, MD

This study is evaluating how ruxolitinib affects premalignant breast cells. One half of the study participants will receive ruxolitinib for approximately 15 days, and the other half will receive a placebo (sugar pill) for approximately 15 days. Once study participants have completed their ruxolitinib or placebo, participants will undergo surgery to remove the premalignant breast tissue.

Ruxolitinib for Premalignant Breast Disease

TBCRC 042 - A Randomized Phase II Window-of-Opportunity Trial of Ruxolitinib in Patients With High Risk and Premalignant Breast Conditions

The number of premalignant breast cells in apoptosis at the time of diagnosis will be compared to the number of cells in apoptosis following treatment with 15 (+/- 5) days of ruxolitinib or placebo.

To determine the difference in change in pSTAT5 levels between diagnosis and surgery as a function of ruxolitinib treatment versus placebo

Incyte Corporation

Translational Breast Cancer Research Consortium

Julie Nangia

Assistant Professor

Elinor Sawyer

The Sloane Project is a UK wide prospective audit of screen detected non-invasive and atypical breast hyperplasias named after John Sloane an eminent pathologist interested in the field. Non invasive breast neoplasia accounts for 25% of all 'breast cancers' detected through breast screening and includes ductal carcinoma in situ (DCIS) and lobular carcinoma in situ (LCIS). Atypical hyperplasias are high risk but benign lesions found in 10% of benign biopsies performed through the NHS breast screening programme. The importance of these lesions rests on the increased risk of subsequently developing invasive breast cancer, with DCIS at highest risk (20 times greater than the general population) followed by LCIS (10 times greater) and atypical breast hyperplasia (4 times greater).

The Sloane Project data are held by Public Health England (PHE) and provide full and detailed information about the patients' journey from diagnosis to treatment and outcome. The project aims to increase the understanding of how best to manage these early lesions which can lead to breast cancer.

All NHS breast screening units in the UK are invited to submit data for the Sloane Project. Historically an exceptional \~90% of centres in England, Scotland, Wales and Northern Ireland have participated on a voluntary basis.

The objective of this research protocol is the collection of anonymised formalin fixed paraffin embedded (FFPE) tissue blocks from women whose data is held within the Sloane Project database in order to allow detailed analysis of the biological, molecular and genomic changes in these cases of in situ carcinoma and atypical hyperplasia and how these relate to the corresponding annotated clinical, pathological and radiological data already collected by and held in PHE. We seek to identify particular signature(s) that define which patients are likely to develop invasive disease, distinguishing the worrisome from indolent, non-worrisome lesions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
X-Ray Mammography Standard of Care Protocol	NCT01052740	Breast Cancer Invasive Carcin... In Situ Carcino... Fibrocystic Cha... Atypical Ductal...		18 Years - 100 Years	National Institutes of Health Clinical Center (CC)
Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical Ductal Hyperplasia	NCT03505372	Atypical Ductal...	Contrast enhanc...	30 Years -	Dana-Farber Cancer Institute
Comparing Vacuum-Assisted Percutaneous Excision to Open Surgical Excision for Borderline or High-Risk Breast Lesions	NCT03868475	Breast Fibroade... Atypical Ductal... Atypical Lobula... Lobular Carcino... Flat Epithelial... Phyllodes; Fibr... Phyllodes Breas... Radial Scar Breast Papillom... Complex Scleros...	Vacuum-assisted... Open surgical e...	18 Years -	Lawson Health Research Institute
Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical Ductal Hyperplasia	NCT03505372	Atypical Ductal...	Contrast enhanc...	30 Years -	Dana-Farber Cancer Institute
Women At Risk: The High Risk Breast Cancer Program	NCT01034891	Breast Cancer		18 Years -	New York Presbyterian Hospital
Excisional Vacuum-Assisted Breast Biopsy	NCT05932758	Atypical Ductal... Ductal Carcinom...	Vacuum-assisted... Not excisional ...	18 Years -	European Institute of Oncology
Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical Ductal Hyperplasia	NCT03505372	Atypical Ductal...	Contrast enhanc...	30 Years -	Dana-Farber Cancer Institute
X-Ray Mammography Standard of Care Protocol	NCT01052740	Breast Cancer Invasive Carcin... In Situ Carcino... Fibrocystic Cha... Atypical Ductal...		18 Years - 100 Years	National Institutes of Health Clinical Center (CC)
Ruxolitinib for Premalignant Breast Disease	NCT02928978	Ductal Carcinom... Atypical Lobula... Atypical Ductal... Lobular Carcino...	Ruxolitinib Placebo (for Ru...	18 Years -	Baylor Breast Care Center
Excisional Vacuum-Assisted Breast Biopsy	NCT05932758	Atypical Ductal... Ductal Carcinom...	Vacuum-assisted... Not excisional ...	18 Years -	European Institute of Oncology
Molecular Analysis of the Sloane Project	NCT05868252	DCIS LCIS Atypical Ductal... Atypical Lobula...		-	King's College London
Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical Ductal Hyperplasia	NCT03505372	Atypical Ductal...	Contrast enhanc...	30 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for atypical ductal hyperplasia