Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Breast Neoplasms

Carcinoma in Situ

Cicatrix

Papilloma

Hyperplasia

Carcinoma, Lobular

Fibroadenoma

Breast Carcinoma In Situ

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Adenocarcinoma

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

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
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
Women At Risk: The High Risk Breast Cancer Program	NCT01034891	Breast Cancer		18 Years -	New York Presbyterian Hospital
Ruxolitinib for Premalignant Breast Disease	NCT02928978	Ductal Carcinom... Atypical Lobula... Atypical Ductal... Lobular Carcino...	Ruxolitinib Placebo (for Ru...	18 Years -	Baylor Breast Care Center
Molecular Analysis of the Sloane Project	NCT05868252	DCIS LCIS Atypical Ductal... Atypical Lobula...		-	King's College London

Spots Global Cancer Trial Database for atypical lobular hyperplasia