Last reviewed · How we verify

NCT03423849

The Maintenance Regimen and Revised Regimen for Advanced Breast Cancer Survivors After First-line Salvage Therapy

Status unknown Phase 2, PHASE3 Last updated 6 February 2018
What this trial tests

Phase 2, PHASE3 trial testing Vinorelbine in Breast Cancer in 200 participants. Status unknown.

Timeline
8 February 2018
Primary endpoint
8 February 2020
8 February 2020

Quick facts

Lead sponsorZhiyong Yu
PhasePhase 2, PHASE3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment200
Start date8 February 2018
Primary completion8 February 2020
Estimated completion8 February 2020

Drugs / interventions tested

Conditions studied

Sponsor

Zhiyong Yu — full company profile →

Who can join

Adults 18 to 70, female only, with Breast Cancer or Chemotherapy Effect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Worldwide, breast cancer is the most incident and prevalent cancer among women. Despite advances in the treatment of advanced breast cancer (ABC) during the past decade, adjuvant systemic therapy has yield little progression for such patients. ABC remains an incurable disease, responsible for approximate 40,000 deaths annually and a median life expectancy of no more than 3 years. The NCCN guidelines clearly define routine adjuvant chemotherapy regimens for the early breast cancer, however, for the patients with recurrence and metastasis, the choice of treatment options is not clear. In this trial, we choose the patients with disease progression who received anthracycline and taxane adjuvant chemotherapy after surgery. The patients received vinorelbine and gemcitabine (NG) or vinorelbine and platinum (NP) regiments for 6 cycles. Then the patients with complete response (CR), partly response (PR) and stable disease(SD) will be assigned to 3 groups, one group will receive the original regiment for 3 cycles to maintain treatment, one group will receive the vinorelbine for 6 cycles, the other group will receive the capecitabine for 6 cycles. Trasuzumab will be used to patients if HER-2 positive. Endocrine therapy will be used if the hormone receptors positive after the chemotherapy. The primary endpoint is to assess disease-free survival (DFS), the secondary endpoint is to assess the overall survival (OS).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Platinum-containing regimens for triple-negative metastatic breast cancer.
    Egger SJ, Chan MMK, Luo Q, Wilcken N. · · 2020 · cited 11× · PMID 33084020 · DOI 10.1002/14651858.cd013750

Verify or expand the search:

Other trials of Vinorelbine

Trials testing the same drug.

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other Zhiyong Yu trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03423849.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing