Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Accelerated partial breast irradiation using 3 x 8.2 Gy to the lumpectomy cavity with a 3mm PTV margin. Treatment duration will be 5-6 days and treatments will be on alternative weekdays, with a minimum interval of 40 hours between subsequent fractions.

partial breast irradiation using 3 x 8.2 Gy to the lumpectomy cavity with a 3mm planning tumor volume (PTV) margin

MRIdian Radiation Treatment Unit

Bethany Anderson, MD

This trial will investigate a novel 3-fraction radiation regimen for participants undergoing breast-conserving therapy (BCT) for early breast cancer that will: 1) significantly reduce the duration of treatment and can be completed in one-week (5 working days) and 2) MRI-guided radiotherapy (MRIdian) would limit the volume of normal tissue radiated and therefore resultant toxicity. The hypothesis is that 3-fraction radiation therapy can be delivered safely without compromising the therapeutic ratio. Participants can expect to be on study for follow up up to 5 years.

This study will have a lead-in phase consisting of 10 patients, followed for 6-months from the date of completion of radiotherapy for the tenth patient. The second phase of accrual (20 patients) will commence only if three or fewer patients (3/10=30%) have CTCAE v 5.0 grade 3 or higher skin toxicity (radiation dermatitis) or Lövey et al. grade 3 or higher fat necrosis.

Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer

A Phase II Study of Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer (MAPBI)

The Harvard Cosmesis Scale will be used to report cosmesis at 1 year post treatment. The physician will report how the breast looks relative to original appearance or untreated breast (excellent, good, fair, poor). The physician answers 9 questions on a scale of 0-2 where 0 is none, 1 is present but does not affect cosmesis, 2 is present and affects cosmesis. Scoring is objective with lower scores indicating improved conditions.

Participant Quality of Life will be assessed prior to starting treatment, at end of radiotherapy (RT), 4 weeks post RT, 6 months post RT, 12 months post RT and yearly through 5 years by collecting measures from three scales.The Breast Cancer Treatment Outcomes Scale (BCTOS) is a 22-item scale scored 1-4 where 1 is none, 2 is slight, 3 is moderate, and 4 is large. Total score ranges from 22-88 where lower scores indicated better outcomes.

Participant Quality of Life will be assessed prior to starting treatment, at end of radiotherapy (RT), 4 weeks post RT, 6 months post RT, 12 months post RT and yearly through 5 years by collecting measures from three scales. The Convenience of Care scale is an 8-item scale scored 0 (not at all) to 10 (a lot). The total score ranges from 0-80 where lower scores indicate less disruptive interventions.

Participant Quality of Life will be assessed prior to starting treatment, at end of radiotherapy (RT), 4 weeks post RT, 6 months post RT, 12 months post RT and yearly through 5 years by collecting measures from three scales.The Medical Outcomes Study Short Form - 36 (MOS SF-36) Vitality scale measures how a participant has felt in the last 4 weeks. 4-items are scored from 1-5 where 1 is all of the time and 5 is none of the time. 4-items are scored from 0 (no pain) to 10 (pain as bad as you can imagine). Total score ranges from 4-60 where lower scores indicate increased vitality.

Fat necrosis will be assessed prior to treatment, at 6 months post RT, at 12 months post RT, and yearly through 5 years, graded as follows: Grade 0 is no fat necrosis, Grade 1 is Asymptomatic fat necrosis (only radiologic and/or cytologic findings), Grade 2 is Symptomatic fat necrosis not requiring medication (palpable mass with or without mild pain), Grade 3 is Symptomatic fat necrosis requiring medication (palpable mass with significant pain), Grade 4 is Symptomatic fat necrosis requiring surgical intervention.

The NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 will be used to identify the type and to grade the severity of acute toxicities. Acute toxicities will be scored from the start of radiation to 90 days after completion of radiotherapy and late toxicities will be scored \> 90 days from completion of radiation therapy.

The NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 will be used to identify the type and to grade the severity of late toxicities.

Defined as evidence of invasive or in situ breast cancer (except LCIS) in the ipsilateral breast. Participants who develop clinical evidence of tumor recurrence in the remainder of the ipsilateral breast must have a biopsy of the suspicious lesion to confirm the diagnosis with documentation of the location.

Defined as the development of tumor in the ipsilateral internal mammary, ipsilateral supraclavicular, ipsilateral infraclavicular and/or ipsilateral axillary nodes, as well as the soft tissue of the ipsilateral axilla, after operation.

Disease free survival (DFS) defined as the time from start of radiation to the time of documented recurrent disease in the ipsilateral breast or regional nodes (supraclavicular, axillary or internal mammary) or distant sites (e.g. bone, liver, lung or brain).

Overall survival (OS) defined as the time from start of radiation to death from any cause.

University of Wisconsin, Madison

Symptoms and General Pathology

Carcinoma

Hyperplasia

Faina Nakhlis, MD

The goal of this study is to determine how often patients who have atypical lobular hyperplasia (ALH) or lobular carcinoma in situ (LCIS) on core needle biopsy of an imaging (found by mammogram or breast ultrasound) abnormality will have associated breast cancer at surgical removal of the area.

Patients will undergo a breast biopsy at which the area found to be ALH or LCIS on core biopsy will be removed surgically through a small incision in the breast.

* The surgical biopsy specimen will be carefully examined by a pathologist, and may be useful in guiding further therapy if needed.
* In the future, tissue from the surgical biopsy may be used to study genetic changes that may be responsible for cancer formation and prevention. The tissue will be kept for future research for up to 10 years.

Option of keeping tissue sample for further research

Upstaging of ALH/LCIS Found on Core Biopsy Based on Subsequent Excisional Biopsy

The Incidence of Adjacent Synchronous Ipsilateral Infiltrating Carcinoma, DCIS, or Atypical Ductal Hyperplasia (ADH) in Patients Diagnosed With Lobular Neoplasia of the Breast by Core Needle Biopsy

Translational Breast Cancer Research Consortium

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Dana-Farber Cancer Institute

Instructor in Surgery, Harvard Medical School

Carcinoma in Situ

Carcinoma, Ductal

Carcinoma, Lobular

Precancerous Conditions

Carcinoma, Intraductal, Noninfiltrating

Breast Carcinoma In Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

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

Julie Nangia

Assistant Professor

Breast Conservation group (Group A) with newly diagnosed breast cancer who decide to proceed with lumpectomy and radiation treatment.

Mastectomy and Reconstruction group (Group B): This group will have mastectomy with immediate reconstruction (defined as reconstruction process starting at time of initial mastectomy surgery). They may or may not require chemotherapy and radiation depending on their cancer staging as well as multiple steps of their breast reconstruction.

Mastectomy Only Cohort: This group will have mastectomy without reconstruction. They may or may not require chemotherapy and radiation.

Terence M. Myckatyn, M.D.

This is an observational study of 3 arms: breast conservation therapy, mastectomy and reconstruction, and mastectomy only.

Tumor: Breast Ratio Study

A Prospective Trial to Assess Tumor :Breast Ratio and Patient Satisfaction in Following Lumpectomy Versus Mastectomy With Reconstruction

The Breast Q is a comprehensive and specific quality of life instrument that allows for patient self-assessment prior to and following breast surgery. Comprised of quality of life and satisfaction domains, and generates domain-specific Q-scores (0-100) constructed using Rasch analysis. The higher the score, the more satisfied the participant was.

-Collected preoperatively (no more than 3 months prior to surgery) and postoperatively (approximately 6 months after conclusion of radiotherapy in the Breast Conservation Cohort and \>=3 months after the final balancing reconstructive intervention in the Mastectomy and Reconstruction Cohort.

Washington University School of Medicine

This is an observational study as such adverse events were not collected.

Breast Conservation group with newly diagnosed breast cancer who decide to proceed with lumpectomy and radiation treatment.

Breast Conservation Cohort

Mastectomy and Reconstruction group: This group will have mastectomy with immediate reconstruction (defined as reconstruction process starting at time of initial mastectomy surgery). They may or may not require chemotherapy and radiation depending on their cancer staging as well as multiple steps of their breast reconstruction.

Mastectomy and Reconstruction Cohort

Mastectomy Only Cohort

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Mastectomy Only cohort was unable to enroll participants due to: participants who chose mastectomy with no reconstruction almost never had an MRI and MRI was a critical inclusion criteria; most of the participants who were approached were older and refused participation; issue with finding and tracking participants who refused reconstruction

Satisfaction with breasts (preop)

Satisfaction with breasts (postop)

Psychosocial well-being (preop)

Psychosocial well-being (postop)

Sexual well-being (preop))

Sexual-well being (postop)

-Mastectomy Only cohort was unable to enroll participants due to: participants who chose mastectomy with no reconstruction almost never had an MRI and MRI was a critical inclusion criteria; most of the participants who were approached were older and refused participation; issue with finding and tracking participants who refused reconstruction

Quality of Life as Measured by the Breast Q

Overall Study

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
Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer	NCT03936478	Breast Cancer DCIS LCIS	MRIdian Radiati...	40 Years -	University of Wisconsin, Madison
Upstaging of ALH/LCIS Found on Core Biopsy Based on Subsequent Excisional Biopsy	NCT00146536	Breast Neoplasm...		20 Years -	Dana-Farber Cancer Institute
Upstaging of ALH/LCIS Found on Core Biopsy Based on Subsequent Excisional Biopsy	NCT00146536	Breast Neoplasm...		20 Years -	Dana-Farber Cancer Institute
Ruxolitinib for Premalignant Breast Disease	NCT02928978	Ductal Carcinom... Atypical Lobula... Atypical Ductal... Lobular Carcino...	Ruxolitinib Placebo (for Ru...	18 Years -	Baylor Breast Care Center
Tumor: Breast Ratio Study	NCT02216136	Breast Cancer LCIS DCIS		18 Years - 72 Years	Washington University School of Medicine
Tumor: Breast Ratio Study	NCT02216136	Breast Cancer LCIS DCIS		18 Years - 72 Years	Washington University School of Medicine
Molecular Analysis of the Sloane Project	NCT05868252	DCIS LCIS Atypical Ductal... Atypical Lobula...		-	King's College London

Spots Global Cancer Trial Database for lcis

Every month we try and update this database with for lcis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lcis

Every month we try and update this database with for lcis cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lcis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.