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Single FrAction Interstitial BreaSt BracHytherApy (SASHA)

16 juni 2026 bijgewerkt door: Virginia Commonwealth University

Single FrAction Interstitial BreaSt BracHytherApy (SASHA)

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

134

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Massey IIT Research Operations
  • Telefoonnummer: 804-628-6430
  • E-mail: masseyepd@vcu.edu

Studie Locaties

  • Verenigde Staten
    • Virginia
      • Richmond, Virginia, Verenigde Staten, 23298
        • Virginia Commonwealth University
        • Contact:
        • Hoofdonderzoeker:
          • Bridget Quinn, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Partial Breast Irradiation
Brachytherapy delivered with multiple interstitial catheters, given in a single fraction over 1 day
Geneesmiddel: Partial Breast Irradiation
16 Gy × 1 fraction via multicatheter brachytherapy delivered over 1 day
Andere namen:
  • Brachytherapie

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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)
Tijdsspanne: 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.
Baseline through 30 days following treatment, up to 5 years.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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)
Tijdsspanne: 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
Baseline, 6 months, 1 year, 3 years, up to 5 years following treatment
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)
Tijdsspanne: 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.
Baseline, 6 months, 1 year, 3 years, up to 5 years following treatment
Assess the rate of excellent or good cosmesis after a 1-day course of APBI utilizing the Harvard Cosmesis Scale
Tijdsspanne: 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.
Baseline, 6 months, then annually up to 5 years following treatment
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
Tijdsspanne: 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).
Baseline, 5 weeks, 6 months, annually up to 5 years following treatment
Assess cumulative treatment-related breast toxicities for up to 5 years after a 1-day course of accelerated partial breast irradiation (APBI)
Tijdsspanne: 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.
Baseline, up to 5 years following treatment
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
Tijdsspanne: 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.
1 year, 3 years, and up to 5 years following treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Virginia Commonwealth University

Onderzoekers

  • Hoofdonderzoeker: Bridget Quinn, MD, Virginia Commonwealth University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

30 september 2036

Studie voltooiing (Geschat)

30 september 2036

Studieregistratiedata

Eerst ingediend

11 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

11 juni 2026

Eerst geplaatst (Werkelijk)

17 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

16 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MCC-25-22764
  • HM300001026 (Andere identificatie: Virginia Commonwealth University)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Ja

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