Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Carcinoma

Breast Neoplasms

Hyperplasia

Breast Diseases

Skin Diseases

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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

Spots Global Cancer Trial Database for alh

Every month we try and update this database with for alh 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 alh

Every month we try and update this database with for alh 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 alh 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.