A Registry Study of Permanent Breast Seed Implant

NCT01106521 | Completed DMC

• 1 other identifier: PBSI Registry
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Neoplasms

Keywords

Infiltrating ductal carcinoma; Brachytherapy

Outcome Measures

Primary Outcomes (1)

• Serious Adverse Events

  Serious Adverse Events (SAE) is an unintended sign, symptom, or syndrome illness that occurs during the period of observation in the clinical study and that is life threatening or result in death. SAE will be coded using the NCI CTC V3.0 scale and corresponds to grade 4 or 5 signs or symptoms.

  Initial and then yearly up to 5 years

Secondary Outcomes (9)

• Breast cancer local recurrence

  Yearly up to 10 years

• Regional recurrence

  Yearly up to 10 years

• Metastases

  Yearly up to 10 years

• PBSI side effects

  After procedure

• PBSI side effects

  At 2 months

Study Arms (1)

PBSI

EXPERIMENTAL

PBSI is a form of accelerated partial breast irradiation involving the insertion of 103-palladium stranded seeds under ultra-sound guidance and light sedation after CT planning in lieu of whole breast adjuvant radiotherapy.

Radiation: Permanent breast seeds implant

Interventions

Permanent breast seeds implant RADIATION

Patients are pre-planned using CT simulation. Implant is realised under light sedation and local freezing. Stranded seeds are inserted using a brachytherapy template that is immobilised to the planned target volume using a 'localization' needle. Patients is released the same day and Quality Assurance involves a 2 months post-implant CT

Also known as: Artemend

PBSI

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• West Penn Allegheny Health System: collaborator
• British Columbia Cancer Agency: collaborator

Study Sites (1)

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N3M5, Canada

Location

Related Publications (4)

• Keller 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 BACKGROUND

• Keller 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 BACKGROUND

• Pignol 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 RESULT

• Pignol 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 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Eric Leung, MD

  Sunnybrook Health Sciences Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2010
• First Posted: April 20, 2010
• Study Start: March 1, 2009
• Primary Completion: January 19, 2018
• Study Completion: January 19, 2018
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

CA (1)