Open Clinical Trials

The FROST Trial

A clinical trial evaluating cryoablation as an alternative to surgery for hormone sensitive stage I breast cancer in women 50 and older

Cryoablation for Triple Negative Breast Cancer

A trial evaluating the effect of cryoablation and immunotherapy on triple negative breast cancer

Cryoablation in Menopausal Women

A study evaluating the role of cryoablation in women 55 and older with hormone sensitive stage I breast cancer undergoing lumpectomy

The FROST Trial

What is The FROST Trial?


The FROST Trial (Freezing Alone Instead of Resection Of Small Breast Tumors: A Study of Cryoablation in the Management of Early Stage Breast Cancer (Clinicaltrials.gov #NCT01992250) This non-randomized study examines the use of cryoablation as an alternative to surgery in the treatment of early stage invasive breast cancer. The hypothesis is that cryoablation will complete ablation and destroy the tumor in a selected population of women who may otherwise be adequately treated with surgery.




What are the criteria for eligibility?


Invasive Breast Cancer ​ER+ or PR+ HER2/neu- Inclusion Criteria (partial list): 1. Age ≥ 50 2. Single invasive breast carcinoma diagnosed by core needle biopsy 3. Estrogen or progesterone positive (+) and HER2 negative (-) 4. Maximum tumor size ≤1.5 cm in its greatest diameter 5. Ultrasound visible tumor 6. Normal appearing lymph nodes 7. Ability to undergo baseline and follow-up breast MRIs 8. Agrees to receive a 5 year minimum course of anti-estrogen medications




Where do I apply?


Contact the clinic nearest you to see how you can become involved in this study. ARIZONA:
Arizona Breastnet (Scottsdale)
tracey@breastnet.net
CALIFORNIA: Dennis R. Holmes, MD, FACS (Los Angeles) alba@drholmesmd.com City Of Hope (Los Angeles) davilez@coh.org EPIC Care (Emeryville) Shoko.Abe@epic-care.com FLORIDA:
Diagnostic Center for Women, LLC (Miami) 305-740-5100 Naples Community Hospital (Naples) Patricia.Pritchard@nchmd.org MICHIGAN:

Ascension Crittenton Hospital (Rochester) michael.cribbs@ascension.org PENNSYLVANIA: Lankenau Medical Center (Wynnewood) SteinbergS@MLHS.ORG RHODE ISLAND:
Rhode Island Hospital (Providence) emorrell@lifespan.org TENNESSEE:
Knoxville Comprehensive Breast Center (Knoxville) mstinnett@kcbc-center.com TEXAS:
Texas Tech University Health Sciences Center (Lubbock) Melanie.Bisbee@umchealthsystem.com UTAH:
Ogden Regional Hospital (Ogden) joshua.kunz@mountainstarhealth.com





 

Cryoablation for Triple Negative Breast Cancer

What is The Cryoablation for Triple Negative Breast Cancer trial?


Peri-Operative Ipilimumab+Nivolumab and Cryoablation Versus Standard Care in Women With Triple-negative Breast Cancer ( Clinicaltrials.gov #NCT03546686) The purpose of this randomized controlled study is to determine the impact of pre-operative cryoablation, ipilimumab and nivolumab (two immunotherapy drugs) versus standard pre-operative care without immunotherapy on 3-year Survival, in women with residual hormone receptor negative, HER2-negative ("triple negative") breast cancer after completing taxane-based neoadjuvant chemotherapy. All patients must undergo lumpectomy or mastectomy after cryoablation.




What are the criteria for eligibility?


Invasive Breast Cancer ER-, PR-, HER2/neu - (Triple negative) >/= 1 cm Inclusion Criteria (partial list): 1. Women age 18 years or older 2. Invasive breast cancer 3. ER, PR and HER2 negative (triple negative) breast cancer 4. Tumor measuring ≥1.0 cm in maximal diameter 5. Any nodal status 6. Multifocal and multicentric disease is permitted. 7. No indication of distant metastases 8. Total mastectomy or lumpectomy planned 9. Visible tumor amenable to cryoablation




Where do I apply?


Contact the clinic nearest you to see how you can become involved in this study. CALIFORNIA: Cedars Sinai Medical Center (Los Angeles) Christina.Abaya@cshs.org





 

Cryoablation in Menopausal Women

What is The FROST Trial?


The FROST Trial (Freezing Alone Instead of Resection Of Small Breast Tumors: A Study of Cryoablation in the Management of Early Stage Breast Cancer (Clinicaltrials.gov #NCT01992250) This non-randomized study examines the use of cryoablation as an alternative to surgery in the treatment of early stage invasive breast cancer. The hypothesis is that cryoablation will complete ablation and destroy the tumor in a selected population of women who may otherwise be adequately treated with surgery.




What are the criteria for eligibility?


Invasive Breast Cancer ​ER+ or PR+ HER2/neu- Inclusion Criteria (partial list): 1. Age ≥ 50 2. Single invasive breast carcinoma diagnosed by core needle biopsy 3. Estrogen or progesterone positive (+) and HER2 negative (-) 4. Maximum tumor size ≤1.5 cm in its greatest diameter 5. Ultrasound visible tumor 6. Normal appearing lymph nodes 7. Ability to undergo baseline and follow-up breast MRIs 8. Agrees to receive a 5 year minimum course of anti-estrogen medications




Where do I apply?


Contact the clinic nearest you to see how you can become involved in this study. ARIZONA:
Arizona Breastnet (Scottsdale)
tracey@breastnet.net
CALIFORNIA: Dennis R. Holmes, MD, FACS (Los Angeles) alba@drholmesmd.com City Of Hope (Los Angeles) davilez@coh.org EPIC Care (Emeryville) Shoko.Abe@epic-care.com FLORIDA:
Diagnostic Center for Women, LLC (Miami) 305-740-5100 Naples Community Hospital (Naples) Patricia.Pritchard@nchmd.org MICHIGAN:

Ascension Crittenton Hospital (Rochester) michael.cribbs@ascension.org PENNSYLVANIA: Lankenau Medical Center (Wynnewood) SteinbergS@MLHS.ORG RHODE ISLAND:
Rhode Island Hospital (Providence) emorrell@lifespan.org TENNESSEE:
Knoxville Comprehensive Breast Center (Knoxville) mstinnett@kcbc-center.com TEXAS:
Texas Tech University Health Sciences Center (Lubbock) Melanie.Bisbee@umchealthsystem.com UTAH:
Ogden Regional Hospital (Ogden) joshua.kunz@mountainstarhealth.com





 
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