Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT05876065

Rekrutiert

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

Interventionsstudie

Phase nicht angegeben

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Sponsor: Wenjin Yin

Zuletzt aktualisiert: 11. September 2025
Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.

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.

Behandlungskategorie

Andere Medikamente

Erforderliche Mutationen

HER2

Studie gestartet

1. Juni 2023

Zuletzt vom Sponsor aktualisiert

11. September 2025

Voraussichtlicher Abschluss

1. Juni 2026

Studienkontakt

Name:Wenjin Yin, M.D.

E-Mail:yinwenjin@renji.com

Telefon:86(21)68385569

Eignung

Einschlusskriterien

* 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

Ausschlusskriterien

* during pregnancy and lactation

* Patients with central nervous system metastasis

Glauben Sie, dass diese klinische Studie fälschlicherweise angezeigt wird?

Design-Details

ZuteilungRandomized

InterventionsmodellParallel Assignment

MaskierungNone (Open Label)

Anzahl der Teilnehmer86

Arme & Interventionen

Arme

Interventionen

Typ: Experimental

Beschreibung: capecitabine and cyclophosphamide as maintenance therapy every 3 weeks

Interventionen:

Ergebnismessungen

Primäre Ergebnismessungen

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.

Sekundäre Ergebnismessungen

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.

Studie vormerken

Studie teilen

Studie herunterladen

Glauben Sie, dass diese klinische Studie fälschlicherweise angezeigt wird?

Studie melden

Studie herunterladen

Studienzentren

Diese Studie hat 1 Studienzentrum

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, CN

Name:Wenjin Yin

Rekrutierend

Shanghai, 200127 CN

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Loading Maps...