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Neoadjuvant Paclitaxel Versus BIBF 1120 Priming Followed by BIBF 1120 Plus Paclitaxel in Early HER-2 Negative Breast Cancer With Proteomic and Dynamic Imaging Correlates

NCT01484080 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2020-01-27

No results posted yet for this study

Summary

The investigators plan to study the efficacy of the combination of weekly paclitaxel + BIBF 1120 in early breast cancer using a neoadjuvant schedule and a randomized phase-II trial design, comparing the efficacy vs. weekly paclitaxel alone, followed by surgery and subsequent standards of care (anthracycline based chemotherapy, radiation or hormonal blockade).

Conditions

Interventions

DRUG

BIBF + Paclitaxel

Priming Period: Oral BIBF 1120 will be administered during 2 weeks at the dose determined during the phase-I part that can be combined safely with weekly paclitaxel, on a continuous schedule for 14 days. One week washout is planned before starting the treatment phase. Treatment Phase: Paclitaxel 80 mg/m2 iv on days 1, 8 and 15 + BIBF 1120 recommended dose bid po days 1-21 q 21 days. (BIBF 1120 morning dose is skipped on the paclitaxel administration days).

DRUG

Paclitaxel

Paclitaxel 80 mg/m2 iv on days 1, 8 and 15 q 21 days. A total of 4 cycles will be administered in both arms.

Sponsors & Collaborators

  • Hospital Universitario de Fuenlabrada

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Hospital Universitari de Bellvitge

    collaborator OTHER

  • Grupo Espanol de Investigacion del Cancer de Mama

    collaborator OTHER

  • Centro Nacional de Investigaciones Oncologicas CARLOS III

    lead OTHER

Principal Investigators

  • Miguel Ángel Quintela, M.D.,PhD · CNIO

  • Ramón Colomer, M.D.,PhD · CNIO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-11-30
Completion
2014-04-30

Countries

  • Spain

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 NCT01484080 on ClinicalTrials.gov