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?


Due to recent sale of the company sponsoring the FROST Trial, the trial is no longer open to enrollment of new patients. Patients already enrolled will continue to have long term follow-up to document the success of the procedure. Dr. Holmes is currently working with the new company for design and obtain approval for a new large scale and more accessible breast cancer cryoablation clinical trial





 

Cryoablation for Triple Negative Breast Cancer

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?


Due to recent sale of the company sponsoring the FROST Trial, the trial is no longer open to enrollment of new patients. Patients already enrolled will continue to have long term follow-up to document the success of the procedure. Dr. Holmes is currently working with the new company for design and obtain approval for a new large scale and more accessible breast cancer cryoablation clinical trial





 

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