deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT00876395

Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer (BOLERO-1)

A Randomized Phase III, Double-Blind, Placebo-Controlled Multicenter Trial of Everolimus in Combination With Trastuzumab and Paclitaxel, as First Line Therapy in Women With HER2 Positive Locally Advanced or Metastatic Breast Cancer

Sponsor: Novartis Pharmaceuticals

Conditions Breast Cancer
Updated 10 times since 2017 Last updated: Dec 18, 2018 Started: Sep 10, 2009 Primary completion: May 30, 2014 Completion: Oct 23, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00876395, this PHASE3 trial focuses on Breast Cancer and remains completed. Sponsored by Novartis Pharmaceuticals, it has been updated 10 times since 2009, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotActive Not Recruiting~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshotActive Not Recruiting~Jun 2017 – ~Jun 2018 · 12 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Jan 2019 · 7 months · monthly snapshotCompleted~Jan 2019 – ~Jan 2021 · 24 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotCompleted~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 8 months · monthly snapshotCompleted

Change History

10 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. Dec 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE3

Show 5 earlier versions
  1. Jan 2019 — Jan 2021 [monthly]

    Completed PHASE3

  2. Jun 2018 — Jan 2019 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  3. Jun 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

  4. Feb 2017 — Jun 2017 [monthly]

    Active Not Recruiting PHASE3

  5. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Sep 2009

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novartis Pharmaceuticals
Data source: Novartis

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