Single FrAction Interstitial BreaSt BracHytherApy

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age40-85
SponsorVirginia Commonwealth University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Partial Breast Irradiation

    Drug

    16 Gy × 1 fraction via multicatheter brachytherapy delivered over 1 day

Treatment groups

134 Participants
are divided into 1 treatment group
Group A: Partial Breast IrradiationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

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.

Time frame
Baseline through 30 days following treatment, up to 5 years.

Secondary outcomes

1

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)

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

Time frame
Baseline, 6 months, 1 year, 3 years, up to 5 years following treatment
2

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)

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.

Time frame
Baseline, 6 months, 1 year, 3 years, up to 5 years following treatment
3

Assess the rate of excellent or good cosmesis after a 1-day course of APBI utilizing the Harvard Cosmesis Scale

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.

Time frame
Baseline, 6 months, then annually up to 5 years following treatment
4

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

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).

Time frame
Baseline, 5 weeks, 6 months, annually up to 5 years following treatment

Other outcomes

Sponsors and contacts

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