Breast Cancer
Conditions
Keywords
Breast Cancer, Radiation
Brief summary
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.
Interventions
16 Gy × 1 fraction via multicatheter brachytherapy delivered over 1 day
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open Label
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess and compare the toxicity of a 1-day course of accelerated partial breast irradiation (APBI) to that of clinical trials: NSABP-B-39 (NCT00103181), RTOG-0413, TRIUMPH-T (NCT02526498), and ASHBY (NCT06185205) | Baseline through 30 days following treatment, up to 5 years. | Incidence of accelerated partial breast irradiation (APBI) related toxicities of interest occurring at grade ≥3 at 1, 3, and 5 years after APBI. The descriptions and grading scales found in the The National Cancer Institutes' (NCI) Common Terminology Criteria for Adverse Events is a descriptive terminology (CTCAE), a list of standardized definitions for adverse events, revised v6.0 will be utilized for adverse (AE) (toxicity) reporting. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI utilizing the Breast Cancer Treatment Outcome Scale (BCTOS-12) | Baseline, 6 months, 1 year, 3 years, up to 5 years following treatment | Cosmetic results at 1, 3, and 5 years after APBI, as assessed by The Breast Cancer Treatment Outcome Scale (BCTOS-12), a shortened, validated patient-reported outcome measure designed to assess aesthetic and functional outcomes after breast-conserving surgery. This is scored on a scale of 1-4 ("no difference" to "large difference"), where lower scores indicate better outcomes of satisfaction |
| Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI utilizing the breast cancer core checklist (postoperative) (BREAST-Q) | Baseline, 6 months, 1 year, 3 years, up to 5 years following treatment | The BREAST-Q radiation-specific module patient-reported outcome measure (PROM) that evaluates patient satisfaction with the cosmetic effects of radiation The Breast-Q is 6 questions and scored on a scale of 1-3 ("not at all" to "a lot") with lower scores indicating better outcomes of satisfaction. |
| Assess the rate of excellent or good cosmesis after a 1-day course of APBI utilizing the Harvard Cosmesis Scale | Baseline, 6 months, then annually up to 5 years following treatment | The Harvard Cosmesis Scale is a physician-rated form will be used by the radiation oncologist to score cosmesis with the following criteria: * Excellent: treated breast looks essentially the same as the contralateral breast as it relates to radiation effects. This includes patients with grade 1 punctate scarring. * Good: minimal but identifiable radiation effects of the treated breast. This includes patients with grade 2 punctate scarring. * Fair: significant radiation effects readily observable. * Poor: severe sequelae of breast tissue secondary to radiation effect. |
| Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI assessed by Digital Photographs | Baseline, 5 weeks, 6 months, annually up to 5 years following treatment | Digital photographs will be taken to visualize any potential changes in breast shape or contour. These will be taken by study staff utilizing the Radiation Oncology Department's designated camera. blindly analyzed by 2-3 radiation oncologists using the following 4-point numerical scale: * 4 (Excellent): the treated breast looks essentially the same as the contralateral breast as it relates to radiation effects. This includes patients with grade 1 punctate scarring. * 3 (Good): minimal but identifiable radiation effects of the treated breast. This includes patients with grade 2 punctate scarring. * 2 (Fair): significant radiation effects readily observable. * 1 (Poor): severe sequelae of breast tissue secondary to radiation effect. Photos will be uploaded to the digital study record. Analysis will be batched as study progresses. Each individual score as well as the average score will be entered into the electronic case report form (eCRF). |
| Assess cumulative treatment-related breast toxicities for up to 5 years after a 1-day course of accelerated partial breast irradiation (APBI) | Baseline, up to 5 years following treatment | Incidence of treatment-related breast toxicities of interest occurring at any grade within 5 years after APBI. Toxicities will be graded using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6. |
| Determine the percentage of patients who remain free of local disease progression (e.g., tumor recurrence or local spread) of breast cancer when treated with a 1-day course of APBI | 1 year, 3 years, and up to 5 years following treatment | Disease control will be assessed by physical examination and mammography. All cases of local failure must be confirmed using pathologic criteria established by Recht et al will be used to help classify the type of local in-breast recurrence as follows: * True Recurrence/Marginal Miss (TR/MM) Failure: a recurrence of the treated cancer within or immediately adjacent to the primary tumor site. * Elsewhere (E) Failure: local recurrence several centimeters from the primary site and is generally believed to be a new primary cancer. Classification of the failure type is at the discretion of the treating investigator. |
Countries
United States
Contacts
CONTACTMassey IIT Research Operations
PRINCIPAL_INVESTIGATORBridget Quinn, MD
Virginia Commonwealth University
Outcome results
None listed