deltatrials
Completed PHASE1 INTERVENTIONAL 4-arm NCT01339442

BKM120 and Fulvestrant for Treating Postmenopausal Patients With Estrogen Receptor-Positive Stage IV Breast Cancer

A Phase 1 Trial of BKM 120, a Novel Oral Selective Phosphatidylinositol-3-kinase (PI3K) Inhibitor, in Combination With Fulvestrant in Postmenopausal Women With Estrogen Receptor Positive Metastatic Breast Cancer

Sponsor: National Cancer Institute (NCI)

Updated 7 times since 2017 Last updated: Jan 23, 2017 Started: Nov 14, 2011 Primary completion: Dec 21, 2016 Completion: Dec 28, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01339442, this PHASE1 trial focuses on Estrogen Receptor-positive Breast Cancer and Recurrent Breast Cancer and remains completed. Sponsored by National Cancer Institute (NCI), it has been updated 7 times since 2011, reflecting limited 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 2018 · 16 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 · 10 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE1

    Status: Active Not RecruitingCompleted

  2. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE1

    First recorded

Nov 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
  • Washington University School of Medicine
Data source: Washington University School of Medicine

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

Study Locations