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 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 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 Cryoablation in Menopausal Women Trial?


Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy ( Clinicaltrials.gov #NCT02576106) Breast Description: The primary objective of this feasibility study is to review the efficacy of cryotherapy in the treatment of breast carcinomas in post-menopausal patients eligible for lumpectomy. All patients undergo lumpectomy after cryoablation.




What are the criteria for eligibility?


Invasive Breast Cancer ER+, PR+, HER2/neu- Inclusion Criteria (partial list):

  1. Non inflammatory invasive ductal breast cancer
  2. Eligible for lumpectomy
  3. Menopausal women with age > 55 years
  4. Tumor size 15 mm or smaller by ultrasonography
  5. Estrogen or progesterone positive (+) and HER2 negative (-)
  6. Good lesion boundary with ultrasonography and MRI
  7. Minimal distance of 5 mm between the skin and the tumor




Where do I apply?


Contact the clinic nearest you to see how you can become involved in this study. FRANCE:
Centre Léon Bérard (Lyon) frank.pilleul@lyon.unicancer.fr





 
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