Completed PHASE3 INTERVENTIONAL 2-arm NCT01953003

Phase III Study of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

A Multicenter, Randomised, Phase III Study of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously

Sponsor: Pierre Fabre Medicament

Conditions Malignant Neoplasm of Breast

Interventions Capecitabine vinflunine

Updated 12 times since 2017 Last updated: Jan 29, 2019 Started: Sep 30, 2013 Primary completion: Jul 31, 2017 Completion: Jul 31, 2017

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Malignant Neoplasm of Breast and is currently completed. Pierre Fabre Medicament leads this study, which shows 12 recorded versions since 2013 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

RECIST 1.1 will be used for tumor assessment CTC - CAE version 3.0 will be used for safety assessment

Status Flow

Change History

12 versions recorded

Jan 2026 — Present [monthly]

Completed PHASE3
Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Dec 2021 — Jul 2024 [monthly]

Completed PHASE3

▶ Show 7 earlier versions

Jan 2021 — Dec 2021 [monthly]

Completed PHASE3
Nov 2020 — Jan 2021 [monthly]

Completed PHASE3
Jun 2019 — Nov 2020 [monthly]

Completed PHASE3
Jun 2018 — Jun 2019 [monthly]

Completed PHASE3
Oct 2017 — Jun 2018 [monthly]

Completed PHASE3

Status: Active Not Recruiting → Completed
Feb 2017 — Oct 2017 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Jan 2017 — Feb 2017 [monthly]

Recruiting PHASE3

First recorded

Sep 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Pierre Fabre Medicament

Data source: Pierre Fabre Medicament

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Beijing, China , Changchun, China , Chengdu, China , Dalian, China , Fuzhou, China , Hangzhou, China , Harbin, China , Jinan, China , Kaohsiung City, Taiwan , Nanjing, China and 7 more locations