๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โค3 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:
* โฅ70 years of age
* Estrogen receptor (ER)+, progesterone receptor (PR)+/-, HER2-
* Grade 1-2 breast cancer
* Tumor โค2 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 โค2 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