Clinical Trials

International Clinical Trials

The following is a list of clinical research trials that we have been active participants.

Targit-B Green

Targit - B Trial: Targeted Intraoperative Radiotherapy for Breast Cancer as a Boost  (ACTIVE)

International trial looking at the use of one treatment radiation therapy given in the operating room while the patient is asleep and undergoing breast preservation cancer surgery. Patients were randomized to standard 6-7 weeks of radiation versus one dose intra-operative radiation followed by 5 weeks of whole breast radiation, and are being followed for many years, tracking survival and recurrence rates. The goal of the study is to determine if intraoperative radiotherapy is more effective than post-operative boost radiation.

Targit Blue Dot

Targit - US: Targeted Intraoperative Radiotherapy US Registry (INACTIVE)

Registry of early breast cancer patients who receive breast preservation surgery with one dose of radiation during surgery without further post-operative radiation.

 

American Society of Breast Sugeons

American Society of Breast Surgeons Nipple Sparing Mastectomy Registry (INACTIVE)

This study is a simple national registry of all patients who undergo nipple-sparing mastectomy in order to delineate the risks of the procedure and the success in preventing cancer and preserving cosmesis.

Neoadjuvant Breast Registry Symphony Trial
Neoadjuvant Breast Registry - Symphony™ Trial (NBRST) (pronounced “in breast”)     (INACTIVE)

Observational prospective study in women with breast cancer that are given chemotherapy or hormonal therapy before they undergo surgery. The breast cancers are assessed with a genetic analysis called Mammoprint - Symphony™. After the treatments and surgery, the results of the genetic analysis are compared to the final pathology. Response rates are determined and linked to the genetic profile of the breast cancer. Hopefully in the future  this will allow us to predict a breast cancer’s response to treatment based upon the genetic analysis using the Mammoprint- Symphony™.  http://www.agendia.com/clinical-trials-nbrst/

Targit 5 Year Results

Targit trial – Targeted Intraoperative Radiotherapy for Breast Cancer  (INACTIVE)

International trial looking at the use of one treatment radiation therapy given in the operating room while the patient is asleep and undergoing breast preservation cancer surgery. Patients were randomized to standard 6-7 weeks of radiation versus one dose intra-operative radiation, and are being followed for many years, tracking survival and recurrence rates. Results have shown so far that recurrence rates for one dose radiation at surgery are equal to standard treatment. http://www.jayantvaidya.org/breast_cancer_surgeon/TARGIT_trial_results.html

Axillary Dissection
American College of Surgeons Z-11 Trial (COMPLETED)

This national study randomized women with breast cancer and metastases in their sentinel nodes to complete removal of the rest of the lymph nodes or to observation with no further node surgery. The results show that women undergoing breast conservation surgery with a nodal metastasis in less than 3 nodes and no extra-nodal extension, had equal survival and recurrence rates if they do not undergo additional node surgery. This study was the most important study in the last decade, since it has allowed thousands of women to avoid unnecessary lymph node dissection which is associated with disabling lymphedema. http://www.aboutcancer.com/acosog_z11_2_11.htm

The following is a list of research projects limited to our breast center.

  • Creation of BRCA 1 / 2 + breast cancer cell lines as part of translational research with SUNY at Albany
  • Institution experience with high-risk women undergoing nipple-sparing one step risk reducing mastectomy. This study reviews risks and successes with the procedure as well as focusing upon the personal experiences of our patients after the surgery.
  • Early breast center experience with intraoperative radiation when combined with post-operative radiation.
  • Reviewing Magnetic Resonance Imaging results in high risk women as relates to breast tissue density by mammography.

Publications and Presentations

  • Multi-Institutional Analysis of Intraoperative Radiotherapy for Early Breast Cancer: Does Age Matter? Abbott AM, Valente SA, ... Kelemen PR, et al. Am J Surg October 2017
  • Effect of Axillary Dissection vs. No Axillary Dissection on 10-year Overall Survival among Women with Invasive Breast Cancer and Sentinel Node Metastasis: the ACOSOG Z0011 (Alliance) randomized clinical trial. Giuliano AE, Ballman KV, ... Kelemen PR, et al. JAMA 2017.
  • TARGIT-R (Retrospective): North American Experience with Intraoperative Radiation Using Low-Kilovoltage X-Rays for Breast Cancer. Valente, SA, Tendulkar, RD, Cherian S,  Kelemen PR… et al. Ann Surg Oncol 2016.
  • Long Term Follow-up of Breast Cancer Patients Treated With Intraoperative Radiotherapy Using the Intrabeam Device. Kelemen PR, Ashikari AY, Ashikari RH, Hilaris B. 11th Annual Meeting of The American Society of Breast Surgeons 2010.
  • Breast Cancer Stages in the Inner-city (Bronx, NY): Racial Disparities Are Observed. Wang JL, Norkus EP, Funicello A, Ahmad S, Mathew CT, Kelemen PR, Cayten CG, and Agarwal N. American College of Surgeons 95th Annual Clinical Congress October 2009 Chicago, IL.
  • Intraoperative Radiotherapy of the Breast. PR Kelemen. Cleveland Clinic 2009 – Breast Cancer Summit
  • Subcutaneous Mastectomy and Immediate Reconstruction for Prevention of Breast Cancer for High-Risk Patients. Ashikari RH, Ashikari AY, Kelemen PR, Salzberg CA. Breast Cancer 2008;15:185-191.
  • Male Breast Cancer: A Single Group Experience. Thu Ma AM, Lawrence C,  R Ashikari, A Ashikari, Kelemen PR. Presented at the Fourth Annual Louis R. M. Del Guercio Surgical Research Day , May 2006, New York Medical College , Valhalla , NY .
  • Preliminary Results of a Clinical Trial Involving the Use of a Novel Intraoperative Radiotherapy Device in Early Breast Cancer Patients. Ashikari, A.Y., Ashikari, R.H., et al. Annals of Surg. Oncol March 2003.
  • Breast Conserving Surgery Plus Intraoperative Radiation Therapy in Primary Operable Breast Cancer: A Novel Therapeutic Approach. Hilaris, B.S., Bodner, W.R., Ashikari, R., Ashikari, A., et al. Brachytherapy 2003.
  • Melanoma Presenting as Circulating Tumor Cells Associated with Failed Angiogenesis. Lee R.T., Fallarino F., Ashikari A., and Gajewski T.F. “ Melanoma Research,  August 2008.
  • Subcutaneous Mastectomy and Immediate Reconstruction for Prevention of Breast Cancer for High-Risk Patients. Ashikari R.H., Ashikari, A.Y., Kelemen P.R., Salzberg C.A.  Breast Cancer 2008.
  • An 8-Year Experience of Direct-to Implant Immediate Breast Reconstruction Using Human Acellular Dermal Matrix (Alloderm). Salzberg A. C., Ashikari A.Y., Koch M. R., Chabner-Thompson E. Plastic and Reconstructive Surgery 2011.

This information does not replace expert evaluation and advice from a trained breast care professional. If you have noted any breast problems please seek care from a breast surgeon as soon as possible.