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A Registry Study of Breast Microseed Treatment

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ClinicalTrials.gov Identifier: NCT02701244
Recruitment Status : Recruiting
First Posted : March 8, 2016
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Concure Oncology-Breast Microseed Inc.

Brief Summary:

For women diagnosed with early stage breast cancer, lumpectomy followed by radiation is a common treatment option. Radiation treatment is typically delivered to the whole breast, five times per week, for anywhere from 3 to 8 weeks. The radiation helps kill any cancer cells that may have been left over following the surgery but causes skin burns. Many studies have demonstrated that radiation to the whole breast is not necessary, that it can be delivered to a portion of the breast where the cancer is more likely to recur.

A technique called a Permanent Breast Seed Implant (PBSI) involving the implantation of radioactive seeds has been developed to deliver the radiation to a portion of the breast. The procedure is performed on an out-patient basis under local anesthesia and light sedation. Because the radioactive seeds are permanently implanted in the breast, the patient is able to live a normal life while the seeds deliver the prescribed radiation to the breast.

Previous studies on PBSI demonstrate that it is a safe and effective alternative form of radiation for appropriately selected patients after lumpectomy. However, those results have been obtained mainly from a single institution, with only 4 patients treated in another center. Further research is still needed to evaluate its safety in a multi-center setting. The purpose of this study is to ensure the appropriate training of clinicians who will be performing this procedure and to capture long term outcomes and rare complications if any.


Condition or disease Intervention/treatment
Breast Neoplasms Radiation: Permanent Breast Seed Implant (PBSI)

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 420 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: A Multicenter Registry Study of Breast Microseed Treatment for Early Stage Breast Cancer
Study Start Date : July 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Permanent Breast Seed Implant (PBSI)
Women with eligible early stage breast cancer who received a permanent breast seed implant status post lumpectomy
Radiation: Permanent Breast Seed Implant (PBSI)
Patients are pre-planned using Computerized Tomography (CT) simulation. Implant is performed after surgery under light sedation and local freezing (alternatively general anesthesia). Stranded seeds are inserted using a brachytherapy template that is immobilized to the planned target volume using a 'localization' needle. Patients are released the same day and Quality Assurance involves post-implant Computerized Tomography (CT).
Other Name: Breast Microseed Treatment




Primary Outcome Measures :
  1. Serious Adverse Events (SAE) [ Time Frame: Up to 10 years from procedure date ]
    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. Serious Adverse Events (SAE) corresponds to grade 4 or 5 signs or symptoms from the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03 scale.


Secondary Outcome Measures :
  1. Breast Cancer Recurrence [ Time Frame: Up to 10 years from procedure date ]

    Ipsilateral in-breast or chest wall recurrence is defined as evidence of invasive or in situ breast cancer (except lobular carcinoma in-situ (LCIS)) in the ipsilateral breast. It is important to get a pathology confirmation of the recurrence.

    In case of ipsilateral recurrence or second primary breast cancer, a copy of the clinic note summarizing the localization (same quadrant, other quadrant, not specified), the pathology, the work-up and treatment plan will be submitted to the Registry. Patients will be followed beyond the diagnosis for survival assessment.


  2. Permanent Breast Seed Implant (PBSI) Side Effects [ Time Frame: At 2 months from procedure date ]
    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 National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03 scale.

  3. Permanent Breast Seed Implant (PBSI) Side Effects [ Time Frame: Yearly up to 10 years from procedure date ]
    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 National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03 scale.

  4. Cosmetic Outcome [ Time Frame: Yearly up to 10 years from procedure date ]
    Cosmetic results will be self-evaluated at each follow-up visit by the patients using the Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire

  5. Survival (either free of cancer or with disease present) [ Time Frame: Up to 10 years from procedure date ]
    Patient survival, either free of cancer or with disease present will be recorded at follow-up appointments



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients are identified during a new patient consult in each participating center.
Criteria

Inclusion Criteria:

  • Histological diagnosis of invasive or in-situ ductal carcinoma (DCIS)
  • Treated by breast conserving surgery with axillary node dissection (with a minimum of 6 nodes sampled) or sentinel lymph node biopsy
  • Surgical margins clear for invasive carcinoma (no tumor at ink margin) or superior or equal to 2 mm for in-situ ductal carcinoma (DCIS)
  • A maximum tumor size of 3 cm
  • Age ≥50 years old
  • Informed consent signed if participating in the Registry

Exclusion Criteria:

  • No previous cancer unless in remission for more than 2 years.
  • Active auto immune disorder with severe vasculitis component
  • Uncontrolled and complicated insulin-dependent diabetes
  • Pregnancy
  • Cosmetic breast implants
  • Psychiatric or addictive disorder that would preclude attending follow-up
  • Post-operative breast infection requiring prolonged antibiotic therapy
  • Lobular features on histology (pure or mixed) or sarcoma histology
  • Node macroscopically 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 with a large post-surgical fluid cavity as determined on the planning Ultrasound (US), resistant to the application of hot compresses for 4 weeks
  • Clear delineation of the target volume on Computerized Tomography (CT) is not possible
  • Volume to be implanted over 150cc
  • Target volume too close to skin such that the 90% isodose overlaps the skin surface

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701244


Contacts
Contact: Juanita Crook, MD +1 250 712 3958 jcrook@bccancer.bc.ca
Contact: Jean-Philippe Pignol, MD, PhD +31 10 704 13 66 j.p.pignol@erasmusmc.nl

Locations
United States, Pennsylvania
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Division of Radiation Oncology    412-359-3400      
Principal Investigator: Mark Trombetta, MD         
United States, Virginia
Mary Washington Hospital Recruiting
Fredericksburg, Virginia, United States, 22401
Principal Investigator: John Chinault, MD         
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Robert Loomis    866-922-6237    Robert.Loomis@swedish.org   
Principal Investigator: Stephen Eulau, MD         
Principal Investigator: Astrid D Morris, MD, MS         
Sponsors and Collaborators
Concure Oncology-Breast Microseed Inc.
Investigators
Principal Investigator: Juanita Crook, MD British Columbia Cancer Agency
Principal Investigator: Jean-Philippe Pignol, MD, PhD Erasmus Medical Center

Publications:
Responsible Party: Concure Oncology-Breast Microseed Inc.
ClinicalTrials.gov Identifier: NCT02701244     History of Changes
Other Study ID Numbers: BMS-001
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Concure Oncology-Breast Microseed Inc.:
Infiltrating Ductal Carcinoma
Ductal Carcinoma In Situ
Brachytherapy
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site

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