deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 3-arm NCT02657343

An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.

Sponsor: Dana-Farber Cancer Institute

Conditions Breast Cancer
Updated 14 times since 2017 Last updated: Jul 28, 2022 Started: Mar 9, 2016 Primary completion: Aug 27, 2020 Completion: Jun 30, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Breast Cancer and is currently completed. Dana-Farber Cancer Institute leads this study, which shows 14 recorded versions since 2016 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~Jan 2018 · 9 months · monthly snapshot~Jan 2018 – ~Jun 2018 · 5 months · monthly snapshot~Jun 2018 – ~Mar 2019 · 9 months · monthly snapshot~Mar 2019 – ~Aug 2019 · 5 months · monthly snapshot~Aug 2019 – ~May 2020 · 9 months · monthly snapshot~May 2020 – ~Jan 2021 · 8 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Jul 2022 · 10 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Jul 2024 · 22 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

14 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  3. Sep 2022 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

    Status: Active Not RecruitingCompleted

  4. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  5. Sep 2021 — Jul 2022 [monthly]

    Active Not Recruiting PHASE1_PHASE2

Show 9 earlier versions
  1. Jan 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  2. May 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  3. Aug 2019 — May 2020 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: RecruitingActive Not Recruiting

  4. Mar 2019 — Aug 2019 [monthly]

    Recruiting PHASE1_PHASE2

  5. Jun 2018 — Mar 2019 [monthly]

    Recruiting PHASE1_PHASE2

  6. Jan 2018 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

  7. Apr 2017 — Jan 2018 [monthly]

    Recruiting PHASE1_PHASE2

  8. Feb 2017 — Apr 2017 [monthly]

    Recruiting PHASE1_PHASE2

  9. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Mar 2016

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Dana-Farber Cancer Institute
  • Novartis
Data source: Dana-Farber Cancer Institute

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

Study Locations