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
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|