PBI for Low-risk Breast Cancer
12. september 2026 opdateret af: Jinli Ma, Fudan University
A Randomized Phase III Trial Comparing 1-Week vs. 3-Week Partial Breast Irradiation Via IMRT After Breast-Conserving Surgery for Clinical Low-Risk Breast Cancer
This non-inferiority, phase 3 clinical trial evaluates the cosmetic non-inferiority of a one-week regimen (26 Gy/5 Fx) versus a three-week regimen (40 Gy/15 Fx) using intensity-modulated radiation therapy (IMRT) for partial breast irradiation (PBI) in low-risk breast cancer patients post-breast-conserving surgery.
It also compares secondary outcomes including efficacy, safety, and quality of life between the two groups.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Shanghai, Kina, 200032
- Fudan University Shanghai Cancer Center
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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:
- Female patients with an estimated life expectancy greater than 5 years.
- Meets criteria for either primary invasive breast cancer or pure ductal carcinoma in situ (DCIS).
- For invasive breast cancer: Age 40-75 years; Underwent breast-conserving surgery with sentinel lymph node biopsy or axillary lymph node dissection; pT ≤ 3 cm (unicentric/unifocal or total multifocal size ≤ 3 cm); favorable histology (invasive ductal, mucinous, tubular, or solid papillary carcinoma, DCIS component permitted); ER+ and/or PR+; pN0(i- or i+); M0; surgical margins ≥ 2 mm.
- For pure DCIS: Age 18-75 years; Underwent breast-conserving surgery with or without sentinel lymph node biopsy; low-to-intermediate nuclear grade; tumor size ≤ 2.5 cm; surgical margins ≥ 3 mm.
- Presence of surgical clips or distinct postoperative seroma/tissue changes in the tumor bed allowing precise target delineation.
- ECOG performance status 0 or 1.
- Eligible for systemic therapy, without prior neoadjuvant systemic therapy.
- Able to tolerate radiotherapy procedures and position immobilization.
- No contraindications to radiotherapy.
- Written informed consent provided.
Exclusion Criteria:
- Unfavorable histological subtypes (e.g., invasive lobular carcinoma, invasive micropapillary carcinoma).
- Positive axillary, internal mammary, or supraclavicular lymph nodes.
- Presence of distant metastasis.
- Paget's disease of the nipple.
- History of prior ipsilateral or contralateral invasive breast cancer or DCIS.
- Bilateral breast cancer.
- Known germline BRCA1 or BRCA2 mutation.
- Prior radiotherapy to the ipsilateral breast, chest wall, or regional lymph nodes.
- Active or prior second malignancy (except adequately treated non-melanoma skin cancer).
- Severe non-malignant comorbidities (e.g., cardiovascular disease, pulmonary disease, systemic lupus erythematosus, or scleroderma) precluding definitive radiotherapy.
- Pregnant or lactating patients.
- Inability or unwillingness to comply with scheduled follow-up visits.
Inability or unwillingness to provide written informed consent.
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 3-week partial breast irradiation (PBI）
Control group
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40.05Gy/15Fx/3w, 2.67Gy/Fx, once daily
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Eksperimentel: 1-week PBI
Experimental group
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26Gy/5Fx/1w, 5.2Gy/Fx, once daily
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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3-year adverse cosmesis
Tidsramme: 3 years
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Adverse cosmetic outcome (defined as 'Fair' or 'Poor') was evaluated by an independent panel using standard photographic assessment based on the EORTC Cosmetic Rating System.
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3 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Acute adverse events
Tidsramme: 6 months
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The incidence and severity of acute adverse event include radiation dermatitis, pruritus, skin pain, radiation esophagitis, and radiation pneumonitis.
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6 months
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Late adverse events
Tidsramme: 3 years
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The incidence and severity of late adverse event include breast induration, skin hyperpigmentation, telangiectasia, breast oedema, and pulmonary fibrosis.
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3 years
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Locoregional recurrence
Tidsramme: 5 years
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Locoregional recurrence is defined as the first documented recurrence in the ipsilateral breast or regional nodes.
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5 years
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Distant metastasis
Tidsramme: 5 years
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Distant metastasis is the first confirmed recurrence in any distant organ/site beyond the ipsilateral breast and regional nodes.
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5 years
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Overall survival
Tidsramme: 5 years
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Overall survival is the time from randomization to death from any cause.
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5 years
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Quality of life (QoL)
Tidsramme: 5 years
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Quality of life will be evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
All multi-item scale and single-item scores are linearly transformed to range from 0 (minimum) to 100 (maximum).
For the global health status/QoL and functional scales, higher scores represent better functioning and a better outcome; for the symptom scales and single items, higher scores represent greater symptom severity and a worse outcome.
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5 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jinli Ma, Fudan University
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 (Faktiske)
13. september 2026
Primær færdiggørelse (Faktiske)
13. september 2026
Studieafslutning (Faktiske)
13. september 2026
Datoer for studieregistrering
Først indsendt
4. september 2026
Først indsendt, der opfyldte QC-kriterier
4. september 2026
Først opslået (Faktiske)
11. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FDRT-BC013
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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