Comparing Ultrafractionated and Moderate Hypofractionated Radiotherapy for Post-Surgery Breast Cancer
Breast Cancer · Radiotherapy
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- Fase 3
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 2872 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
This phase III, multicenter, prospective, randomized controlled trial evaluates whether ultrafractionated radiotherapy (26Gy/5Fx) is non-inferior to moderate hypofractionated radiotherapy (40Gy/15Fx) in terms of local-regional recurrence for breast cancer patients after curative surgery (breast-conserving surgery or mastectomy). A total of 2,872 patients will be enrolled from 14 Chinese centers. Participants will be stratified by surgery type, lymph node status, TNBC subtype, and neoadjuvant chemotherapy status. The primary endpoint is local-regional recurrence rate; secondary endpoints include overall survival, disease-free survival, distant metastases, breast cancer-specific survival, toxicity, cosmetic outcomes, and quality of life. This study will provide high-level evidence on whether a 5-fraction ultra-hypofractionated regimen can safely replace the standard 15-fraction moderately hypofractionated regimen in the post-operative setting.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- 1\. Age ≥ 18 years, female or male. 2. Histologically confirmed invasive breast carcinoma. 3. Underwent curative-intent breast cancer surgery, including total mastectomy or breast-conserving surgery, with microscopically negative margins (ink-negative margins).
4\. Axillary staging performed by sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND).
5\. For patients undergoing breast-conserving surgery:
1. Negative surgical margins (ink-negative margins).
2. Meets indications for tumor bed boost: ipsilateral multifocal disease is permitted; patients at low risk who may be exempt from boost are excluded: age ≥ 50 years, T1N0, histological grade I-II, ER-positive.
3. If primary surgery without neoadjuvant chemotherapy: pathological stage T1-3N0-3a (excluding N2b).
4. If neoadjuvant chemotherapy was received: clinical stage T1-3N0-2 and pathological stage T0-3N0-3a (excluding N2b).
6\. For patients undergoing total mastectomy:
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1. Has indications for local ± regional radiotherapy.
2. Without neoadjuvant chemotherapy: pathological stage T3N0, or T1-3 N1-3a (excluding N2b).
3. With neoadjuvant chemotherapy: clinical stage T3N0, or T1-3N1-2, and pathological stage T0-3N0-3a (excluding N2b).
7\. No evidence of metastatic disease. 8. ECOG performance status 0-1.
Exclusion Criteria:
* 1\. Initial pathological diagnosis of ductal carcinoma in situ (DCIS) without invasive carcinoma.
2\. T4 breast cancer, including inflammatory breast cancer. 3. Clinical or pathological stage with pathologically confirmed positive supraclavicular, infraclavicular, or internal mammary lymph nodes, or radiologically suspicious nodes considered to require boost irradiation.
4\. Patients who have undergone implant-based breast reconstruction, including prosthetic reconstruction or tissue expander placement.
5\. Known BRCA mutation carriers (testing is not required but if known, patients are excluded).
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Sin enmascaramiento
Ultrafractionated Radiotherapy
26Gy in 5 fractions to the breast/chest wall with or without regional nodal irradiation. For breast-conserving surgery patients, a simultaneous integrated boost (SIB) of 31Gy in 5 fractions is delivered to the tumor bed.
Radiation: Ultrafractionated Radiotherapy
Moderately Hypofractionated Radiotherapy
40Gy in 15 fractions to the breast/chest wall with or without regional nodal irradiation. For breast-conserving surgery patients, a simultaneous integrated boost (SIB) of 48Gy in 15 fractions is delivered to the tumor bed.
Radiation: Moderately Hypofractionated Radiotherapy
Ultrafractionated Radiotherapy RADIATION
26Gy in 5 fractions (5.2Gy per fraction) to the breast/chest wall; SIB of 31Gy in 5 fractions (6.2Gy per fraction) for tumor bed after breast-conserving surgery. Regional nodal irradiation is permitted per protocol criteria.
Moderately Hypofractionated Radiotherapy RADIATION
Moderately hypofractionated radiotherapy delivered to the breast/chest wall with or without regional nodal irradiation. The total dose is 40 Gy in 15 fractions (2.67 Gy per fraction) over 3 weeks. For patients undergoing breast-conserving surgery, a simultaneous integrated boost (SIB) of 48 Gy in 15 fractions (3.2 Gy per fraction) is delivered to the tumor bed. Regional nodal irradiation includes internal mammary nodes (IMN), supraclavicular nodes (SCN), and/or level I-II axillary nodes (ALN) as clinically indicated per protocol.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Local-Regional Recurrence (LRR)
Plazo: 5 years
Time from randomization to the first event of ipsilateral breast, chest wall, supraclavicular, axillary, or internal mammary nodal recurrence.
Medidas secundarias
Acute and Late Toxicities
Plazo: 5 years
Assessment of radiation-related toxicities, including shoulder joint dysfunction, upper limb edema, shoulder pain, acute radiation skin reaction, radiation esophagitis, cardiovascular events (myocardial infarction, heart failure, acute coronary syndrome, valvular disease), radiation pneumonitis and pulmonary fibrosis, hypothyroidism, and brachial plexus injury.
Overall Survival (OS)
Plazo: 5 years
Time from randomization to death from any cause.
Disease-Free Survival (DFS)
Plazo: 5 years
Time from randomization to the first event of local-regional recurrence, distant recurrence, death from any cause, contralateral breast cancer, or second primary cancer.
Distant Metastasis-Free Survival (DMFS)
Plazo: 5 years
Time from randomization to the first event of recurrence at any site other than local-regional.
Breast Cancer-Specific Survival (BCSS)
Plazo: 5 years
Time from randomization to death due to breast cancer. Deaths from causes other than breast cancer will be handled according to the prespecified statistical analysis plan.
EORTC Quality of Life Questionnaire (EORTC-QLQ-C30; version 3)
Plazo: 5 years
Assessment of treatment-related symptoms, health-related quality of life via the EORTC Quality of Life Questionnaire (EORTC-QLQ-C30; version 3)
breast cancer module (QLQ-BR23)
Plazo: 5 years
Assessment of treatment-related symptoms, health-related quality of life via questionnaire breast cancer module (QLQ-BR23)
the Quick Disabilities of the Arm, Shoulder and Hand (q-DASH) questionnaire.
Plazo: 5 years
Assessment of upper limb function via the Quick Disabilities of the Arm, Shoulder and Hand (q-DASH) questionnaire.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
1 centros
Fudan University Shanghai Cancer CenterShanghai, Shanghai Municipality, ChinaEstado desconocido
Equipo y fechas
- Patrocinador principal
- Fudan University
- Inicio del estudio
- 1 ago 2026 Real
- Finalización primaria
- 2033-08 Estimado
- Finalización del estudio
- 2036-07 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Ultrafractionated Radiotherapy Versus Moderate Hypofractionated Radiotherapy After Radical Surgery for Breast: A Prospective, Multicenter, Randomized, Phase 3 Clinical Trial
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026