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Breast NeoplasmsNCT01106521

A Registry Study of Permanent Breast Seed Implant

A study testing Permanent breast seeds implant in people with Breast Neoplasms, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Permanent breast seeds implant
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
1 siteCanada
Study dates
Mar 2009to 19 Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Sunnybrook Odette Cancer Centre

    Toronto, Ontario, M4N3M5

Other trials in Canada

About this study

Official title: A Multicentre Registry Study of Permanent Breast Seed Implant (PBSI) for Early Stage Breast Cancers.

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.

Read the 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.

Being tested
Permanent breast seeds implant
Keywords
Infiltrating ductal carcinoma, Brachytherapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Permanent breast seeds implantRadiation

    Also called Artemend

    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

Study groups in NCT01106521
Study groupRoleWhat they receive
PBSIExperimentalPBSI 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.
Receives: Radiation: Permanent breast seeds implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Initial and then yearly up to 5 years

Secondary outcomes (9)

  1. Breast cancer local recurrence

    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.

    Measured: Yearly up to 10 years

  2. Regional recurrence

    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).

    Measured: Yearly up to 10 years

  3. Metastases

    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

    Measured: Yearly up to 10 years

  4. PBSI side effects

    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.

    Measured: After procedure

  5. PBSI side effects

    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.

    Measured: At 2 months

  6. PBSI side effect

    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.

    Measured: At 6 months

  7. PBSI side effect

    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).

    Measured: Yearly up to 10 years

  8. Cosmetic outcome

    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.

    Measured: Yearly up to 10 years

  9. Survival

    Patient survival, either free of cancer or with disease present will be recorded at follow-up appointments.

    Measured: Yearly up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2010 (estimated)
  2. Study startMar 2009
  3. Primary completion19 Jan 2018
  4. Study completion19 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
420 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01106521
Sponsor's protocol ID
PBSI Registry
Status last verified
Oct 2021
First submitted
9 Apr 2010
Last updated
29 Oct 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17967512

  • 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.

    PubMed 15890575

  • 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.

    PubMed 18930602

  • 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.

    PubMed 16182464

Questions about this trial

What is this clinical trial studying?

A study testing Permanent breast seeds implant in people with Breast Neoplasms, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serious Adverse Events (time frame: Initial and then yearly up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01106521, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.

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