A Registry Study of Breast Microseed Treatment

NCT02701244 | Recruiting DMC

• 1 other identifier: BMS-001
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Neoplasms

Keywords

Infiltrating Ductal Carcinoma; Ductal Carcinoma In Situ; Brachytherapy; Breast Neoplasms; Breast Diseases; Neoplasms; Neoplasms by Site

Outcome Measures

Primary Outcomes (1)

• Serious Adverse Events (SAE)

  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.

  Up to 10 years from procedure date

Secondary Outcomes (5)

• Breast Cancer Recurrence

  Up to 10 years from procedure date

• Permanent Breast Seed Implant (PBSI) Side Effects

  At 2 months from procedure date

• Permanent Breast Seed Implant (PBSI) Side Effects

  Yearly up to 10 years from procedure date

• Cosmetic Outcome

  Yearly up to 10 years from procedure date

• Survival (either free of cancer or with disease present)

  Up to 10 years from procedure date

Study Arms (1)

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)

Interventions

Permanent Breast Seed Implant (PBSI) RADIATION

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).

Also known as: Breast Microseed Treatment

Permanent Breast Seed Implant (PBSI)

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are identified during a new patient consult in each participating center.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Concure Oncology-Breast Microseed Inc.: lead

Study Sites (3)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Mary Washington Hospital

Fredericksburg, Virginia, 22401, United States

RECRUITING

Swedish Cancer Institute

Seattle, Washington, 98104, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 18930602 BACKGROUND

• Pignol JP, Caudrelier JM, Crook J, McCann C, Truong P, Verkooijen HA. Report on the Clinical Outcomes of Permanent Breast Seed Implant for Early-Stage Breast Cancers. Int J Radiat Oncol Biol Phys. 2015 Nov 1;93(3):614-21. doi: 10.1016/j.ijrobp.2015.07.2266. Epub 2015 Jul 21.

  PMID: 26461003 BACKGROUND

• 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.

  PMID: 16182464 BACKGROUND

• 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.

  PMID: 17967512 BACKGROUND

• 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.

  PMID: 15890575 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating; Breast Diseases; Neoplasms; Neoplasms by Site

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Juanita Crook, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

• Jean-Philippe Pignol, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juanita Crook, MD

CONTACT

+1 250 712 3958; jcrook@bccancer.bc.ca

Jean-Philippe Pignol, MD, PhD

CONTACT

+31 10 704 13 66; j.p.pignol@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 8, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2021
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 19, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)