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Paclitaxel and BKM120 Before Surgery in Treating Patients With Stage II or III Estrogen Receptor-Positive and HER2-Negative Breast Cancer

NCT01953445 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-12-08

No results posted yet for this study

Summary

This phase II trial studies the effects of paclitaxel combined with phosphoinositide 3-kinase (PI3K) inhibitor BKM120 in patients with stage II or III breast cancer that is described as estrogen receptor-positive, human epidermal growth factor 2 (HER2)-negative and endocrine therapy resistant. Drugs such as paclitaxel stop the growth of tumors by blocking cancer cell division. PI3K inhibitor BKM120 inhibits some of the enzymes needed for cell growth and may improve the response of endocrine resistant tumors to treatment. Giving paclitaxel and PI3K inhibitor BKM120 before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Conditions

  • Breast Neoplasms

Interventions

DRUG

paclitaxel

DRUG

BKM120

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Foluso Ademuyiwa, M.D., M.P.H. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-06-30
Completion
2015-07-31

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Entities

Drugs

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 NCT01953445 on ClinicalTrials.gov