deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT02384239

A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer

Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Hormone Receptor Positive Metastatic Breast Cancer Previously Exposed to Inhibitors of the PI3K Pathway: A Phase II Study With Pharmacodynamics Markers

Sponsor: Dana-Farber Cancer Institute

Conditions Hormone Receptor Positive Metastatic Breast Cancer
Interventions Fulvestrant Palbociclib Tamoxifen
Updated 13 times since 2017 Last updated: Feb 16, 2022 Started: Oct 19, 2015 Primary completion: Jan 31, 2021 Completion: Jan 31, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Hormone Receptor Positive and Metastatic Breast Cancer, this trial is completed. The trial is conducted by Dana-Farber Cancer Institute and has accumulated 13 data snapshots since 2015. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshot~Jun 2018 – ~Apr 2019 · 10 months · monthly snapshot~Apr 2019 – ~May 2020 · 13 months · monthly snapshot~May 2020 – ~Jan 2021 · 8 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Apr 2022 · 13 months · monthly snapshot~Apr 2022 – ~Dec 2022 · 8 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

13 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE2

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE2

▶ Show 8 earlier versions

  1. Apr 2022 — Dec 2022 [monthly]

    Completed PHASE2

  2. Mar 2021 — Apr 2022 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  3. Jan 2021 — Mar 2021 [monthly]

    Active Not Recruiting PHASE2

  4. May 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

  5. Apr 2019 — May 2020 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  6. Jun 2018 — Apr 2019 [monthly]

    Recruiting PHASE2

  7. Feb 2017 — Jun 2018 [monthly]

    Recruiting PHASE2

  8. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

Oct 2015

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
  • Translational Breast Cancer Research Consortium
  • University of California, San Francisco
Data source: University of California, San Francisco

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

Study Locations