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Single FrAction Interstitial BreaSt BracHytherApy (SASHA)

16 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

134

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Massey IIT Research Operations
  • Número de telefone: 804-628-6430
  • E-mail: masseyepd@vcu.edu

Locais de estudo

  • Estados Unidos
    • Virginia
      • Richmond, Virginia, Estados Unidos, 23298
        • Virginia Commonwealth University
        • Contato:
        • Investigador principal:
          • Bridget Quinn, MD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Partial Breast Irradiation
Brachytherapy delivered with multiple interstitial catheters, given in a single fraction over 1 day
Medicamento: Partial Breast Irradiation
16 Gy × 1 fraction via multicatheter brachytherapy delivered over 1 day
Outros nomes:
  • Braquiterapia

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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)
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Virginia Commonwealth University

Investigadores

  • Investigador principal: Bridget Quinn, MD, Virginia Commonwealth University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

30 de setembro de 2036

Conclusão do estudo (Estimado)

30 de setembro de 2036

Datas de inscrição no estudo

Enviado pela primeira vez

11 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de junho de 2026

Primeira postagem (Real)

17 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • MCC-25-22764
  • HM300001026 (Outro identificador: Virginia Commonwealth University)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Sim

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