Clinical trial NCT02297672: Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant
Official title: Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Early Stage Breast Cancer
Keywords: breast cancer
brachytherapy
partial breast radiotherapy
palladium 103
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 75
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Permanent Breast Seed Implant (PBSI) has been demonstrated to be a well accepted and well tolerated form of partial breast radiotherapy. This protocol aims to build on the initial experience and to further refine the technique and collect toxicity and cost data, especially in comparison to alternate forms of breast radiotherapy.

Detailed description: 25 women with low stage (pT1pN0) breast cancer, grade 1 or 2, will be accrued for adjuvant partial breast radiotherapy using PBSI and prospectively followed for 5 years. The primary aims is to evaluate implant quality according to recognized dosimetric parameters. Secondary aims include elaboration of approaches to different technical scenarios imposed by variation in seroma size, shape and location within the breast (expanding the technical manual to include recommended approaches to implants in different sectors of the breast and in different size breasts), incorporation of the use of live 3D ultrasound in the procedure (as opposed to current use of 2D US), assessment of patient acceptance and quality of life, physician assessment of cosmesis, assessment of toxicity, and recording of cost to the patient and health care system compared to alternate forms of breast radiotherapy.

Eligibility criteria: Inclusion Criteria:

* Patient consent and signature of approved consent form.

  * Age greater than 55 years and postmenopausal.
  * Life expectancy of at least ten years
  * Stage 0 or I breast cancer. Tumour size \< 2 cm.
  * Invasive cancer must be pathologic grade 1 or 2
  * Histology must be either Ductal Carcinoma In Situ or invasive ductal adenocarcinoma of the breast.
  * Tumour removed by lumpectomy with clear margins (DCIS and invasive).
  * Unifocal disease
  * For invasive breast cancer, axillary staging by either sentinel node biopsy or axillary dissection (minimum of 6 axillary nodes). Not required for DCIS.
  * Brachytherapy generally should be performed within 16 weeks of the last surgery (lumpectomy, re-excision of margins, or axillary staging procedure). If \> 16 weeks, will be assessed on case-by-case basis, based on seroma visibility and the presence of surgical clips in the tumour bed.
  * Tumour must be Estrogen Receptor positive.
  * The lumpectomy cavity (seroma) must be clearly delineated by ultrasound and CT and should be \< 3 cm diameter (equivalent sphere) resulting in a maximum of 125 cc planning target volume (PTV).
  * Breast seed implant must be considered technically deliverable by interstitial brachytherapy by the attending radiation oncologist and must be a minimum 2-plane implant.
  * If prior non-breast malignancies, must have been disease-free for 5 or more years. Time limit waived for carcinoma in-situ of the cervix or colon, melanoma in-situ, and basal or squamous cell carcinoma of the skin.

Exclusion Criteria:

* Stage T2 or higher breast cancer

  * Histologically positive axillary nodes.
  * High grade (grade 3) invasive ductal carcinoma
  * Extensive DCIS
  * Lymphatic or Vascular Invasion positive
  * Significant persistent post surgical complications
  * Palpable or radiographically suspicious ipsilateral or contralateral axillary, or regional nodes, unless histologically confirmed negative.
  * Suspicious microcalcifications, densities, or palpable abnormalities in the ipsilateral or contralateral breast unless confirmed benign.
  * Proven multi-centric carcinoma (invasive cancer or DCIS)
  * Paget's disease of the nipple.
  * Synchronous bilateral invasive or non-invasive breast cancer.
  * History of previous ipsilateral invasive breast cancer or DCIS.
  * Surgical margins that are positive or cannot be microscopically assessed.
  * Clear delineation of the target lumpectomy cavity not possible.
  * Breast implants.
  * Prior ipsilateral breast or thoracic radiotherapy.
  * Known genetic mutation in Breast Cancer Associated (BRCA 1 or 2)
  * Collagen vascular disease,

Primary outcomes:
measure: Implant quality
timeFrame: Day 0
Secondary outcomes:
measure: Eligibility for implant based on seroma size and location within breast
timeFrame: Day 0
measure: Feasibility of 3D US for procedure guidance
timeFrame: Day 0
measure: Cosmesis
timeFrame: 5 years
measure: Acute and Late Toxicity of breast brachytherapy
timeFrame: 5 years
measure: Patient Assessed Quality of life using the NSABP/RTOG breast Cancer Quality of Life questionnaire
timeFrame: 5 years
measure: Dose to Organs at risk
timeFrame: Day 0
measure: Cost
timeFrame: 5 years
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: BCCA Center for the Southern Interior
state: British Columbia
Study officials:
affiliation: British Columbia Cancer Agency
name: Juanita Crook, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Keller BM, Ravi A, Sankreacha R, Pignol JP. Permanent breast seed implant dosimetry quality assurance. Int J Radiat Oncol Biol Phys. 2012 May 1;83(1):84-92. doi: 10.1016/j.ijrobp.2011.05.030. Epub 2011 Oct 20.
citation: Olivotto IA, Whelan TJ, Parpia S, Kim DH, Berrang T, Truong PT, Kong I, Cochrane B, Nichol A, Roy I, Germain I, Akra M, Reed M, Fyles A, Trotter T, Perera F, Beckham W, Levine MN, Julian JA. Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy. J Clin Oncol. 2013 Nov 10;31(32):4038-45. doi: 10.1200/JCO.2013.50.5511. Epub 2013 Jul 8.