deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT00561119

Maintenance Versus Observation After 6 Cycles of Gemcitabine Plus Paclitaxel in Pts With Advanced Breast Cancer

Phase III, Multicenter, Randomized Trial of Maintenance Versus Observation After Achieving Clinical Response in Pts With Metastatic or Recurrent Breast Cancer Who Received 6 Cycles of Gemcitabine Plus Paclitaxel(GP) as 1st-line Chemotherapy

Sponsor: Korean Cancer Study Group

Conditions Advanced Breast Cancer
Interventions gemcitabine , paclitaxel
Updated 7 times since 2017 Last updated: Apr 27, 2017 Started: May 31, 2007 Primary completion: Dec 31, 2016 Completion: Dec 31, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00561119, this PHASE3 trial focuses on Advanced Breast Cancer and remains completed. Sponsored by Korean Cancer Study Group, it has been updated 7 times since 2007, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Jun 2017 · 5 months · monthly snapshotUnknown Status~Jun 2017 – ~Jun 2018 · 12 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 11 months · monthly snapshotCompleted

Change History

7 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

▶ Show 2 earlier versions

  1. Jun 2017 — Jun 2018 [monthly]

    Completed PHASE3

    Status: Unknown Status → Completed

  2. Jan 2017 — Jun 2017 [monthly]

    Unknown Status PHASE3

    First recorded

May 2007

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Korean Cancer Study Group
  • Samsung Medical Center
Data source: Samsung Medical Center

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

Study Locations