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
|ClinicalTrials.gov Identifier: NCT01484080|
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : April 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: BIBF + Paclitaxel Drug: Paclitaxel||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Randomized Clinical Trial of 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|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||April 2014|
Experimental: Arm I: BIBF1120+Paclitaxel
2 weeks run-in of BIBF 1120 alone followed by paclitaxel + BIBF 1120 combination
Drug: BIBF + Paclitaxel
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.
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).
Active Comparator: Arm II: Paclitaxel
Paclitaxel monotherapy treatment will start within 2 weeks after randomization.
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.
- Pathologic complete response [ Time Frame: Within 30 days after surgery ]Pathologic complete response defined as the absence of tumor cells assessed on the surgical specimen + residual Ductal Carcinoma In Situ (DCIS) in the breast.
- Determine predicting factors at the phosphoproteomic signature and its correlation with response to BIBF-1120 [ Time Frame: Baseline and end of priming phase. ]1. Determination of phosphoproteomic signatures in tumor biopsy. Patients in arm-2 will undergo a baseline biopsy with the aim of establishing a signature predicting response to docetaxel alone, and by comparison with the signature in the arm-1, extracting the signalling nodes implicated in docetaxel response from those implicated in angiogenic blockade response.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484080
|Hospital Universitari de Bellvitge|
|Hospitalet de Llobregat, Barcelona, Spain, 08907|
|Hospital Universitario de Fuenlabrada|
|Fuenlabrada, Madrid, Spain, 28942|
|MD Anderson Cancer Centre Madrid|
|Madrid, Spain, 28033|
|Study Director:||Miguel Ángel Quintela, M.D.,PhD||CNIO|
|Principal Investigator:||Ramón Colomer, M.D.,PhD||CNIO|