NCT01339442 is a Phase 1 clinical trial of BKM120 in Estrogen Receptor-positive Breast Cancer, sponsored by Washington University School of Medicine.

Who is sponsoring NCT01339442?

NCT01339442 is sponsored by Washington University School of Medicine.

What drugs are being tested in NCT01339442?

Interventions in NCT01339442: BKM120, Fulvestrant, biopsy.

What condition does NCT01339442 study?

NCT01339442 studies Estrogen Receptor-positive Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer.

Is NCT01339442 still recruiting?

NCT01339442 is currently completed. Last updated 25 January 2017.

Last reviewed 2017-01-25 · How we verify

NCT01339442

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 25 January 2017

What this trial tests

Phase 1 trial testing BKM120 in Estrogen Receptor-positive Breast Cancer in 31 participants. Completed in 28 December 2016.

Timeline

14 November 2011

Primary endpoint
21 December 2016

28 December 2016

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	14 November 2011
Primary completion	21 December 2016
Estimated completion	28 December 2016
Sites	1 location across United States

Drugs / interventions tested

BKM120 — full drug profile →
Fulvestrant (fulvestrant) — full drug profile →
biopsy — full drug profile →

Conditions studied

Estrogen Receptor-positive Breast Cancer — all drugs for Estrogen Receptor-positive Breast Cancer →
Recurrent Breast Cancer — all drugs for Recurrent Breast Cancer →
Stage IV Breast Cancer — all drugs for Stage IV Breast Cancer →

Sponsor

Washington University School of Medicine

Who can join

18 and older, female only, with Estrogen Receptor-positive Breast Cancer or Recurrent Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial will determine the Maximum Tolerated Dose (MTD) of BKM120 when given together with fulvestrant in treating postmenopausal patients with estrogen receptor-positive (ER+) stage IV breast cancer. The toxicity profile of this combination therapy will also be described. Inhibition of PI3K by BKM120 may enhance programmed cell death (apoptosis) in estrogen receptor positive (ER+) breast cancer cells. Giving fulvestrant together with BKM 120 may enhance this apoptotic effect, providing a novel therapeutic strategy for patients with metastatic ER+ breast cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The PI3K/AKT/mTOR pathway in breast cancer: targets, trials and biomarkers.
Paplomata E, O'Regan R. · · 2014 · cited 425× · PMID 25057302 · DOI 10.1177/1758834014530023
Role of PI3K/AKT pathway in cancer: the framework of malignant behavior.
Jiang N, Dai Q, Su X, Fu J, et al · · 2020 · cited 419× · PMID 32333246 · DOI 10.1007/s11033-020-05435-1
Epigenetic mechanisms in breast cancer therapy and resistance.
Garcia-Martinez L, Zhang Y, Nakata Y, Chan HL, et al · · 2021 · cited 319× · PMID 33741974 · DOI 10.1038/s41467-021-22024-3
PIK3CA mutations in androgen receptor-positive triple negative breast cancer confer sensitivity to the combination of PI3K and androgen receptor inhibitors.
Lehmann BD, Bauer JA, Schafer JM, Pendleton CS, et al · · 2014 · cited 260× · PMID 25103565 · DOI 10.1186/s13058-014-0406-x
PI3K/AKT/mTOR-Targeted Therapy for Breast Cancer.
Zhu K, Wu Y, He P, Fan Y, et al · · 2022 · cited 117× · PMID 36010585 · DOI 10.3390/cells11162508
Clinical potential of novel therapeutic targets in breast cancer: CDK4/6, Src, JAK/STAT, PARP, HDAC, and PI3K/AKT/mTOR pathways.
Hosford SR, Miller TW. · · 2014 · cited 109× · PMID 25206307 · DOI 10.2147/pgpm.s52762
Efficacy of PI3K inhibitors in advanced breast cancer.
Verret B, Cortes J, Bachelot T, Andre F, et al · · 2019 · cited 92× · PMID 31859349 · DOI 10.1093/annonc/mdz381
Resistance and Overcoming Resistance in Breast Cancer.
Luque-Bolivar A, Pérez-Mora E, Villegas VE, Rondón-Lagos M. · · 2020 · cited 86× · PMID 33204149 · DOI 10.2147/bctt.s270799

Verify or expand the search:

Other trials of BKM120

Trials testing the same drug.

NCT02220855 — A Study of BKM120 (Buparlisib) in Relapsed or Refractory Thymomas · Phase 2 · completed
NCT02113878 — Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cancer of Head and Neck · Phase 1 · completed
NCT02159066 — LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma · Phase 2 · completed
NCT02000882 — STAR Cape+BKM120 MBC With Brain Met · Phase 2 · completed
NCT02088684 — Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer · Phase 1 · completed

Other recruiting trials for Estrogen Receptor-positive Breast Cancer

Currently open trials in the same condition.

NCT06439693 — The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer · Phase 2 · recruiting
NCT04597580 — Personalised Disease Monitoring in Metastatic Breast Cancer · active not recruiting
NCT02957968 — Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca · Phase 2 · active not recruiting
NCT01953588 — Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery · Phase 3 · active not recruiting

Other Washington University School of Medicine trials

Trials by the same sponsor.

NCT05521997 — Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer · Phase 2 · not yet recruiting
NCT07101666 — Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer · Phase 2 · not yet recruiting
NCT07200089 — Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel) · Phase 1 · not yet recruiting
NCT07313592 — Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients · not yet recruiting
NCT07419464 — 5-Fluorouracil Response and Optimization STudy (The FROST Trial) · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01339442 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
Last refreshed: 25 January 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01339442.

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