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Single FrAction Interstitial BreaSt BracHytherApy (SASHA)

16 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

134

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Massey IIT Research Operations
  • Numero di telefono: 804-628-6430
  • Email: masseyepd@vcu.edu

Luoghi di studio

  • Stati Uniti
    • Virginia
      • Richmond, Virginia, Stati Uniti, 23298
        • Virginia Commonwealth University
        • Contatto:
        • Investigatore principale:
          • Bridget Quinn, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Partial Breast Irradiation
Brachytherapy delivered with multiple interstitial catheters, given in a single fraction over 1 day
Droga: Partial Breast Irradiation
16 Gy × 1 fraction via multicatheter brachytherapy delivered over 1 day
Altri nomi:
  • Brachiterapia

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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)
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Virginia Commonwealth University

Investigatori

  • Investigatore principale: Bridget Quinn, MD, Virginia Commonwealth University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

30 settembre 2036

Completamento dello studio (Stimato)

30 settembre 2036

Date di iscrizione allo studio

Primo inviato

11 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 giugno 2026

Primo Inserito (Effettivo)

17 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MCC-25-22764
  • HM300001026 (Altro identificatore: Virginia Commonwealth University)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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