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Trial of BKM120/Tamoxifen-combination in Patients With HR-pos, HER2-neg Breast Cancer

NCT02404844 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-04-20

No results posted yet for this study

Summary

This is a clinical trial with a molecularly stratified parallel cohort, single arm design to explore the efficacy and safety of BKM120 in combination with tamoxifen in patients with ER/PR-positive, HER2-negative breast cancer with prior exposure to antihormonal therapy, and different biomarker profiles, two of them potentially indicative of constitutive PI3K pathway activation.

Conditions

Interventions

DRUG

BKM120

daily oral

DRUG

Tamoxifen

daily oral

Sponsors & Collaborators

  • iOMEDICO AG

    collaborator INDUSTRY

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • University Hospital, Essen

    lead OTHER

Principal Investigators

  • Anja Welt, MD · University Hospital, Essen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-09-19
Completion
2017-10-19

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02404844 on ClinicalTrials.gov