A Registry Study of Permanent Breast Seed Implant

• 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.
  
  

• 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.
  
  

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.