No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
40 – 85
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
134 (estimated)
Sponsor
Virginia Commonwealth University · Other
Who this trial is looking for
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This phase 2, single arm prospective study has been designed to determine the safety of delivering accelerated partial breast irradiation (APBI) with a multicatheter interstitial implant in a single fraction over 1 day. This is a method of delivering radiation therapy directly into or close to a tumor.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Female
* New diagnosis of Ductal Carcinoma in Situ (DCIS) and/or invasive breast carcinoma per histologic evaluation
* Age 40-85 at diagnosis
* Previous lumpectomy with surgical margins histologically free of invasive tumor and DCIS as determined by the pathologist
* T stage o…
Inclusion Criteria:
* Female
* New diagnosis of Ductal Carcinoma in Situ (DCIS) and/or invasive breast carcinoma per histologic evaluation
* Age 40-85 at diagnosis
* Previous lumpectomy with surgical margins histologically free of invasive tumor and DCIS as determined by the pathologist
* T stage of Tis, T1, or T2
* T2 tumors must be ≤3 cm in maximum diameter
* If the tumor is human epidermal growth factor receptor (HER2)-positive, the patient is planning to receive or has already received HER2-directed therapy
* For patients with invasive breast cancer, an axillary staging procedure must be performed (either sentinel node biopsy alone or axillary dissection \[with a minimum of 6 axillary nodes removed\]) and the axillary node(s) must be pathologically negative Note: N0(i+) is not an exclusion criterion
Note: Patients meeting all of the following criteria are not required to undergo the axillary staging procedure:
* ≥70 years of age
* Estrogen receptor (ER)+, progesterone receptor (PR)+/-, HER2-
* Grade 1-2 breast cancer
* Tumor ≤2 cm in size
Note: If patients meet all the following criteria, the decision to avoid sentinel lymph node biopsy can be at the discretion of the breast surgeon:
* 50-69 years of age
* Grade 1-2 breast cancer
* Clinically negative axilla by ultrasound and/or magnetic resonance imaging (MRI)
* ER+, PR+, HER2-
* Tumor ≤2 cm in size
* Agrees to comply with aromatase inhibitor recommendation
* Ability to begin brachytherapy within 12 weeks following lumpectomy, re- excision of margins, or completion of chemotherapy
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Pregnant or breastfeeding
* Active collagen-vascular disease
* Paget's disease of the breast
* Any prior history of DCIS or invasive breast cancer prior to the current diagnosis
* Any prior history of breast radiation therapy (RT) or thoracic RT for any condition
* Multicentric carcinoma (DCIS or invasive)
* Synchronous bilateral invasive or non-invasive breast cancer
* Surgical margins that cannot be microscopically assessed or that are positive
* Treatment with neoadjuvant chemotherapy
* Excision cavity that cannot be clearly delineated or is not amenable to implant per the treating investigator
* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
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