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

NCT01248494 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2016-07-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

BEZ235

* Dose level 1: 400mg PO BID * Dose level -1: 400mg PO in AM and 200mg PO in PM * Dose level -2: 200mg PO BID

DRUG

BKM 120

* Dose Level 1: BKM120, 100 mg PO daily * Dose level -1: BKM120, 80 mg PO daily * Dose Level -2: BKM120, 60 mg PO daily

DRUG

Letrozole

All levels: 2.5mg/day PO

DRUG

BKM120

* Dose Level 1: BKM120, 100 mg PO from Mondays through Fridays, weekly * Dose level -1: BKM120, 80 mg PO from Mondays through Fridays, weekly * Dose Level -2: BKM120, 60 mg PO from Mondays through Fridays, weekly

Sponsors & Collaborators

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Ingrid Mayer, MD · Vanderbilt-Ingram Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-12-31
Completion
2016-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01248494 on ClinicalTrials.gov