A Registry Study of Permanent Breast Seed Implant

NCT ID: NCT01106521

Last Updated: 2021-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2018-01-19

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.

Detailed Description

For early stage breast cancer, accelerated partial breast irradiation is an alternative treatment option to whole breast irradiation after breast conserving surgery. Our group has previously reported results of a Phase I/II study of permanent breast seed implant (PBSI) using palladium-103 seeds as an alternative to whole breast radiotherapy for well selected breast cancer patients. The procedure is realised in a single session under light sedation and local freezing. After a median FU of 54 months no patients has recurred on a cohort of 67 patients, and acute of delayed side effect compared favourably to external beam radiotherapy.

Yet this study was a single centre study and the sample size did not allow evaluating appropriately the risk of serious adverse events (SAE). The current study propose evaluating SAE on a multicentre and larger cohort of 420 patients.

Conditions

Breast Neoplasms

Keywords

Infiltrating ductal carcinoma; Brachytherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PBSI

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.

Group Type: EXPERIMENTAL

Permanent breast seeds implant

Intervention Type: 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

Interventions

Permanent breast seeds implant

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

Intervention Type: RADIATION

Other Intervention Names

Artemend

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

West Penn Allegheny Health System

OTHER

Sponsor Role: collaborator

British Columbia Cancer Agency

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Eric Leung

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Leung, MD

Role: STUDY_CHAIR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 17967512 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15890575 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18930602 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16182464 (View on PubMed)

Other Identifiers

PBSI Registry

Identifier Type: -

Identifier Source: org_study_id