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Completed

NCT Number: NCT01106521

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.

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N3M5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Artemend

Primary outcomes

  1. Serious Adverse Events

    Time frame: Initial and then yearly up to 5 years

    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 outcomes

  1. Breast cancer local recurrence

    Time frame: Yearly up to 10 years

    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.

  2. Regional recurrence

    Time frame: Yearly up to 10 years

    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).

  3. Metastases

    Time frame: Yearly up to 10 years

    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

  4. PBSI side effects

    Time frame: After procedure

    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.

  5. PBSI side effects

    Time frame: At 2 months

    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.

  6. PBSI side effect

    Time frame: At 6 months

    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.

  7. PBSI side effect

    Time frame: Yearly up to 10 years

    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).

  8. Cosmetic outcome

    Time frame: Yearly up to 10 years

    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.

  9. Survival

    Time frame: Yearly up to 10 years

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

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • British Columbia Cancer Agency
  • West Penn Allegheny Health System

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Apr 20, 2010
Registry last updated
Oct 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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