Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT05876065

Reclutamento in corso

Capecitabine and Cyclophosphamide (XC) as Maintenance Therapy for Advanced Breast Cancer

Interventistico

Fase non elencata

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Sponsor: Wenjin Yin

Ultimo Aggiornamento: 11 settembre 2025
Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.

To compare the efficacy and safety of capecitabine and cyclophosphamide (XC) versus physician's choice as maintenance therapy for patients with advanced breast cancer who achieved disease control after salvage treatment.

Categoria di Trattamento

Altri Farmaci

Mutazioni richieste

HER2

Studio Iniziato

1 giugno 2023

Ultimo Aggiornamento dello Sponsor

11 settembre 2025

Completamento Stimato

1 giugno 2026

Contatto dello studio

Nome:Wenjin Yin, M.D.

Email:yinwenjin@renji.com

Telefono:86(21)68385569

Idoneità

Criteri di Inclusione

* Female, age≥18 years old

* ECOG≤2

* Pathologically confirmed primary breast cancer, with pathologically or radiologically confirmed recurrent or metastatic lesions

* HR+/HER2+ or HR-/HER2+ or HR-/HER2-

* At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1

* Disease control (complete response + partial response + stable disease) after salvage treatment

* Expected survival ≥6 months

* Adequate organ function

Criteri di Esclusione

* during pregnancy and lactation

* Patients with central nervous system metastasis

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Dettagli del Disegno

AllocazioneRandomized

Modello di InterventoParallel Assignment

MascheramentoNone (Open Label)

Numero da Arruolare86

Bracci e Interventi

Bracci

Interventi

Tipo: Experimental

Descrizione: capecitabine and cyclophosphamide as maintenance therapy every 3 weeks

Interventi:

Misure di Esito

Misure di Esito Primarie

Progression-Free Survival (PFS)From the date of starting maintenance therapy to the date of first documentation of disease progression or death from any cause (up to approximately 1 year)

PFS is defined as the time from the date of starting maintenance therapy to the date of disease progression or death from any cause, whichever occurs first.

Misure di Esito Secondarie

Adverse eventsFrom the date of starting maintenance therapy to the end of the treatment (up to approximately 1 year)]

Adverse events during maintenance therapy will be assessed according to the NCI CTCAE v5.0.

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Siti dello Studio

Questo studio ha 1 sito

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, CN

Nome:Wenjin Yin

In fase di reclutamento

Shanghai, 200127 CN

Renji Hospital, School of Medicine, Shanghai Jiaotong University

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