A Registry Study of Permanent Breast Seed Implant

Women found to have early stage breast cancer will have their cancer surgically removed followed by radiation treatment to the entire breast, five times per week for several weeks. The radiation treatment prevents the cancer from growing back but creates skin burns. Several studies have showed that it is nor necessary treating the whole breast. The investigators team has pioneered a new therapy realizing the permanent implantation of tiny radioactive seeds into the surgical cavity in a single one hour procedure under light anesthesia. Patients live a normal life while receiving the radiation treatment. The results of a first clinical trial on 67 patients shows that the treatment is well tolerate and efficient. The purpose of the study is to offer the treatment in several places and to increase the cohort of patient to 420 to capture rare complications if any.

Sex

Female

Minimum age

50 Years

Inclusion Criteria:

* A confirmed histological diagnosis of invasive breast carcinoma
* Treated by breast conserving surgery with axillary node dissection (with a minimum of 6 nodes sampled) or sentinel lymph node biopsy
* Surgical margins clear over or equal to 2 mm
* A maximum tumor size of 3 cm
* Age \>= 50 years old
* ECOG performance status of 0 or 1
* Informed consent signed

Exclusion Criteria:

* Previous history of cancer other than curable skin SCC or Tis or T1 cervix
* Patient receiving anti-coagulant that cannot be stopped two weeks prior PBSI
* Autoimmune disorder
* Diabetes insulin-dependant
* Pregnancy
* Breast implants
* Psychiatric or addictive disorder that would preclude attending follow-up
* Post-operative breast infection
* Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign)
* Lobular features on histology (pure or mixed) or sarcoma histology
* Node positive on axillary dissection or in the sentinel lymph node biopsy
* Extensive in situ carcinoma
* Multicentric disease (in more than one quadrant or separated by 2 cm or more)
* Paget's disease of the nipple
* Metastases
* Patients presenting a post-surgical fluid cavity ≥ 2.5 cm in diameter in any dimension as determined on the planning US
* Clear delineation of the target volume on CT is not possible
* Having a volume to be implanted over 120cc
* Having a target volume too close to skin such that the 85% isodose overlaps the skin surface)
* Having a target volume too close to the chest wall, such that there is a risk of perforating the chest wall

• BACKGROUNDKeller BM, Pignol JP, Rakovitch E, Sankreacha R, O'Brien P. A radiation badge survey for family members living with patients treated with a (103)Pd permanent breast seed implant. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):267-71. doi: 10.1016/j.ijrobp.2007.08.006. Epub 2007 Oct 29. PMID 17967512
• BACKGROUNDKeller B, Sankreacha R, Rakovitch E, O'brien P, Pignol JP. A permanent breast seed implant as partial breast radiation therapy for early-stage patients: a comparison of palladium-103 and iodine-125 isotopes based on radiation safety considerations. Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):358-65. doi: 10.1016/j.ijrobp.2004.10.014. PMID 15890575
• RESULTPignol JP, Rakovitch E, Keller BM, Sankreacha R, Chartier C. Tolerance and acceptance results of a palladium-103 permanent breast seed implant Phase I/II study. Int J Radiat Oncol Biol Phys. 2009 Apr 1;73(5):1482-8. doi: 10.1016/j.ijrobp.2008.06.1945. Epub 2008 Oct 18. PMID 18930602
• RESULTPignol JP, Keller B, Rakovitch E, Sankreacha R, Easton H, Que W. First report of a permanent breast 103Pd seed implant as adjuvant radiation treatment for early-stage breast cancer. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):176-81. doi: 10.1016/j.ijrobp.2005.06.031. Epub 2005 Sep 22. PMID 16182464