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Risk-Stratified Hypofractionated Radiotherapy After Breast-Conserving Surgery for Early Breast Cancer

14. juni 2026 opdateret af: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

A Prospective Study of Risk-Stratified Hypofractionated Radiotherapy After Breast-Conserving Surgery for Early Breast Cancer

This prospective study is designed to evaluate the feasibility, efficacy, and safety of risk-stratified hypofractionated radiotherapy after breast-conserving surgery in patients with early breast cancer.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Eligible patients with early breast cancer who have undergone breast-conserving surgery will be stratified into a high-risk group or a low-risk group according to the presence or absence of predefined high-risk factors.

Patients in the high-risk group will receive whole-breast irradiation with a simultaneous integrated boost to the tumor bed. The prescribed dose will be 36 Gy in 15 fractions over 3 weeks to the whole breast and 48 Gy in 15 fractions over 3 weeks to the tumor bed.

Patients in the low-risk group will receive partial-breast irradiation. Two hypofractionated schedules may be used: 40.05 Gy in 15 fractions over 3 weeks or 26 Gy in 5 fractions over 1 week.

Patients will be followed during and after radiotherapy to evaluate treatment efficacy, recurrence rates, and acute and late radiation-related toxicities.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

649

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100021
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • ECOG performance status score of 0 to 2.
  • Pathologically confirmed breast cancer, including invasive carcinoma or ductal carcinoma in situ.
  • Clinical stage cT0-2N0M0.
  • Underwent breast-conserving surgery.
  • Negative surgical margins greater than 2 mm.

Exclusion Criteria:

  • Regional lymph node metastasis.
  • Distant metastasis.
  • Bilateral breast cancer.
  • Prior thoracic radiotherapy.
  • Life expectancy of less than 5 years.
  • Lactating or pregnant women.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm 1: High-risk group

Patients who undergo upfront breast-conserving surgery will be assigned to the high-risk group if any of the following high-risk factors are present:

  • Age younger than 40 years.

    • Histology of invasive lobular carcinoma or micropapillary carcinoma.

      • Multifocal disease, defined as two or more breast tumor foci.

        • Tumor size greater than 3 cm.

          • Lymphovascular invasion.

            • Invasive carcinoma with an extensive intraductal component.

              • Estrogen receptor-negative disease.

Patients who receive neoadjuvant chemotherapy followed by breast-conserving surgery will be assigned to the high-risk group if any of the following high-risk factors are present:

  • Age younger than 40 years.

    • Histology of invasive lobular carcinoma or micropapillary carcinoma.

      • Multifocal breast tumor before treatment.

        • Lymphovascular invasion.

          • Pathologic stage ypT1-2N0.
Stråling: Whole-breast irradiation and tumor bed boost
Whole-breast irradiation: 36 Gy in 15 fractions; Tumor bed boost: 48 Gy in 15 fractions
Aktiv komparator: Arm 2: Low-risk group

Patients who undergo upfront breast-conserving surgery will be assigned to the low-risk group if they meet either of the following criteria:

① Ductal carcinoma in situ (DCIS): age 40 years or older, unifocal disease on breast MRI, tumor size 3 cm or smaller, estrogen receptor-positive disease, and low-, intermediate-, or high-grade disease.

② Invasive carcinoma, including invasive ductal carcinoma, mucinous carcinoma, papillary carcinoma, or tubular carcinoma: age 40 years or older, unifocal disease on breast MRI, tumor size 3 cm or smaller, grade 1 to 3 disease, no lymphovascular invasion, and estrogen receptor-positive disease.

Patients who receive neoadjuvant chemotherapy followed by breast-conserving surgery will be assigned to the low-risk group if all of the following criteria are met: Age 40 years or older, unifocal disease on pretreatment breast MRI, pretreatment core needle biopsy showing invasive ductal carcinoma, and pathologic stage ypT0/isN0.
Stråling: Partial-breast irradiation
Partial-breast irradiation: 40.05 Gy in 15 fractions or 26 Gy in 5 fractions

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Local recurrence rate
Tidsramme: Five years
Ipsilateral breast recurrence rate
Five years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Disease-free survival rate
Tidsramme: Five years
Disease-free survival rate
Five years
Radiation-related adverse events
Tidsramme: Five years
Adverse events
Five years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juni 2026

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2032

Datoer for studieregistrering

Først indsendt

14. juni 2026

Først indsendt, der opfyldte QC-kriterier

14. juni 2026

Først opslået (Faktiske)

18. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NCC25/095-0095

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Brystkræft

Kliniske forsøg med Whole-breast irradiation and tumor bed boost

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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