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Clinical trialNCT01248494CompletedPhase 1Interventional

PhIb BKM120 or BEZ235+Endocrine Treatment in Post-Menopausal Patients With Hormone Receptor + Metastatic Breast Cancer

SponsorVanderbilt-Ingram Cancer CenterEnrollment72Metastatic Breast Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is an open-label phase Ib multi-institution trial that evaluates the safety profile/tolerability and preliminary anti-tumor effect of BKM120 (a PI3K inhibitor) and endocrine therapy combination and BEZ235 (a PI3K/ mTOR inhibitor) and endocrine therapy combination in postmenopausal patients with hormone receptor-positive metastatic breast cancer.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Alabama

    Birmingham, Alabama, United States

  • Massachusetts General Hospital, Dana Farber Cancer Center

    Boston, Massachusetts, United States

  • Columbia University Medical Center

    New York, New York, United States

  • Vanderbilt Breast Center One Hundred Oaks

    Nashville, Tennessee, United States

  • Vanderbilt Cool Springs

    Nashville, Tennessee, United States

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

BEZ235BKM 120Buparlisib →Letrozole →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Nov 2010
Primary completion
31 Dec 2012
Completion
31 May 2016
Last update posted
25 Jul 2016
Registered enrollment
72
Registry id
NCT01248494
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.