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A Randomized, Phase 2, Neoadjuvant Study of Weekly Paclitaxel With or Without LCL161 in Patients With Triple Negative Breast Cancer

NCT01617668 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 209

Last updated 2016-10-17

Study results available
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Summary

To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer whose tumors are positive for a defined pattern of gene expression

Conditions

Interventions

DRUG

LCL161

LCL161 was available as 300 mg, tablets, which was supplied in child-resistant bottles.

DRUG

paclitaxel

Commercially available paclitaxel was sourced locally by each study site. Generic paclitaxel could be used for study treatment. iv 80mg/m2

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States
  • Australia
  • Brazil
  • Czechia
  • Germany
  • Ireland
  • Italy
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT01617668 on ClinicalTrials.gov