A Registry Study of Permanent Breast Seed Implant

This study is currently recruiting participants.
Verified February 2013 by Sunnybrook Health Sciences Centre
Sponsor:
Collaborators:
West Penn Allegheny Health System
British Columbia Cancer Agency
Information provided by (Responsible Party):
Jean-Philippe Pignol, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01106521
First received: April 9, 2010
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Breast Neoplasms
Radiation: Permanent breast seeds implant

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre Registry Study of Permanent Breast Seed Implant (PBSI) for Early Stage Breast Cancers.

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Serious Adverse Events [ Time Frame: Initial and then yearly up to 5 years ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Breast cancer local recurrence [ Time Frame: Yearly up to 10 years ] [ Designated as safety issue: No ]
    Ipsilateral in-breast or chest wall recurrence is defined as evidence of invasive or in situ breast cancer (except LCIS) in the ipsilateral breast. Patients will have a biopsy of the suspicious lesion to confirm the diagnosis with documentation of the location.

  • Regional recurrence [ Time Frame: Yearly up to 10 years ] [ Designated as safety issue: No ]
    Regional recurrence is defined as the development of tumor in regional nodes as well as the soft tissue of the ipsilateral axilla after axillary dissection. The regional recurrence is suspected on imaging and/or clinical symptoms and must be documented with fine needle aspiration. Also the localisation of the nodal recurrence must be reported (internal mammary chain, supra-clavicular area or axilla).

  • Metastases [ Time Frame: Yearly up to 10 years ] [ Designated as safety issue: No ]
    Distant recurrence is defined as evidence of tumor in any area of the body. The metastasis recurrence should be proved by appropriate imaging, biopsy or fine needle aspiration

  • PBSI side effects [ Time Frame: After procedure ] [ Designated as safety issue: No ]
    Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.

  • PBSI side effects [ Time Frame: At 2 months ] [ Designated as safety issue: No ]
    Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.

  • PBSI side effect [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.

  • PBSI side effect [ Time Frame: Yearly up to 10 years ] [ Designated as safety issue: No ]
    Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale. Fat necrosis will be diagnosed either by mammography or clinically (prolonged indurations and pain in the area of seeds implantation without evidence of infection).

  • Cosmetic outcome [ Time Frame: Yearly up to 10 years ] [ Designated as safety issue: No ]
    Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist. An excellent cosmetic result score is assigned when the treated breast looked essentially the same as the contralateral breast (as it relates to radiation effects). A good cosmetic score is assigned for minimal but identifiable radiation effects of the treated breast. A fair score means significant radiation effects were readily observable. A poor score is used for severe sequelae of breast tissue secondary to radiation effects.

  • Survival [ Time Frame: Yearly up to 10 years ] [ Designated as safety issue: No ]
    Patient survival, either free of cancer or with disease present will be recorded at follow-up appointments.


Estimated Enrollment: 420
Study Start Date: March 2009
Estimated Study Completion Date: March 2024
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Radiation: 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
Other Name: Artemend

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106521

Contacts
Contact: Jean-Philippe Pignol, MD, PhD 416 480 6100 ext 5329 jean-philippe.pignol@sunnybrook.ca
Contact: Eileen Rakovitch, MSc 416 480 6100 ext 4806 eileen.rakovitch@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Jean-Philippe Pignol, MD, PhD    416 480 6100 ext 5329    jean-philippe.pignol@sunnybrook.ca   
Contact: Eileen Rakovitch, MSc    416 480 6100 ext 4806    eileen.rakovitch@sunnybrook.ca   
Principal Investigator: Jean-Philippe Pignol, MD, PhD         
Sub-Investigator: Eileen Rakovitch, MSc         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
West Penn Allegheny Health System
British Columbia Cancer Agency
Investigators
Study Chair: Jean-Philippe Pignol, MD, PhD Sunnybrook Health Sciences Centre
  More Information

Publications:
Responsible Party: Jean-Philippe Pignol, Dr, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01106521     History of Changes
Other Study ID Numbers: PBSI Registry
Study First Received: April 9, 2010
Last Updated: February 28, 2013
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Infiltrating ductal carcinoma
Brachytherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014