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O estudo clínico NCT06769919 para Câncer de mama está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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A Randomized Controlled Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined with Systemic Therapy for Early-stage Breast Cancer Fase II, Fase III 340 Randomizado
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06769919 vai avaliar tratamento para Câncer de mama. Este é um estudo intervencionista de Fase II Fase III. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 31 de dezembro de 2024, com o objetivo de incluir 340 participantes. Coordenado por Xijing Hospital e deve ser concluído em 31 de dezembro de 2031. Essas informações foram atualizadas no ClinicalTrials.gov em 10 de janeiro de 2025.
Resumo
A total of 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity were enrolled and divided into two groups. The control group received neoadjuvant systemic therapy followed by surgery and adjuvant radiotherapy. The experimental group received neoadjuvant systemic therapy and neoadjuvant radiotherapy followed by surgery. The treatment response of breast cancer, patient survival ti...Mostrar mais
Descrição detalhada
This study is a randomized, controlled, open-label clinical trial, planned to enroll 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity. Participants will be divided into two groups. The control group will receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy. The experimental group will receive neoadjuvant systemic therapy combined with neoadjuva...Mostrar mais
Título oficial
A Randomized Controlled Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined with Systemic Therapy for Early-stage Breast Cancer
Condições médicas
Câncer de mamaOutros IDs do estudo
- WZ-1
Número NCT
Data de início (real)
2024-12-31
Última atualização postada
2025-01-10
Data de conclusão (estimada)
2031-12-31
Inscrição (estimada)
340
Tipo de estudo
Intervencionista
FASE
Fase II
Fase III
Fase III
Status
Ainda não recrutando
Palavras-chave
radiotherapy
system therapy
system therapy
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Nenhuma intervençãoAdjuvant radiotherapy receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy | N/A |
ExperimentalNeoadjuvant radiotherapy receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery | Radioterapia neoadjuvante The experimental group will receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Residual Cancer Burden (RCB) 0/I | Residual Cancer Burden (RCB) is a standardized method used to quantify the amount of residual disease in breast cancer patients after neoadjuvant therapy (treatment given before surgery). It is calculated based on the size of the primary tumor, the cellularity of the tumor bed, and the extent of lymph node involvement. RCB is divided into four categories:
RCB-0: Pathologic complete response (pCR), meaning no residual invasive cancer is found in the breast or lymph nodes.
RCB-I: Minimal residual disease, indicating a very small amount of cancer remains after treatment.
RCB-II: Moderate residual disease. RCB-III: Extensive residual disease. RCB-0 and RCB-I are often associated with better prognoses and higher survival rates compared to RCB-II and RCB-III | From enrollment to the end of treatment at 8 weeks |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Event-Free Survival (EFS) | Event-Free Survival (EFS) is defined as the time from randomization to the occurrence of any event, including disease progression, discontinuation of treatment for any reason, or death. | From enrollment to 10 years later or death. |
Invasive Disease-Free Survival (iDFS) | From enrollment to 10 years later or death. | |
Overall Survival (OS) | From enrollment to 10 years later or death. | |
Quality of life scores | From enrollment to 3 years after treatment completion. | |
ECOG performance status scores | From enrollment to 3 years after treatment completion. | |
Surgical incision healing scores | From enrollment to 1 years after treatment completion. | |
Adverse Events (AEs) | From enrollment to 3 years after treatment completion. |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Feminino
- Female patients aged ≥18 years and ≤65 years；
- newly diagnosed breast cancer;
- Axillary lymph node biopsy-positive;
- ECOG performance status score of 0-1;
- metastatic breast cancer or bilateral breast cancer;
- inflammatory breast cancer;
- Pregnancy and Lactation;
Xijing HospitalContato central do estudo
Contato: Ju liang Zhang, 029-84775271, [email protected]
Contato: Mei ling Huang, 029-84775271, [email protected]
1 Locais do estudo em 1 países
Shaanxi
Xijing hospital, Xi'an, Shaanxi, 710032, China
Ju liang Zhang, Contato, 029-84775271, [email protected]