Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer
|ClinicalTrials.gov Identifier: NCT01036087|
Recruitment Status : Active, not recruiting
First Posted : December 21, 2009
Last Update Posted : May 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Panitumumab Drug: Nab-paclitaxel Drug: Carboplatin Drug: 5-Fluorouracil Drug: Epirubicin Drug: Cyclophosphamide||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients With Primary Inflammatory Breast Cancer (IBC) Without HER2 Overexpression|
|Actual Study Start Date :||November 2010|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
U.S. FDA Resources
Experimental: PNC + FEC
PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and
FEC = 5-fluorouracil, epirubicin, and cyclophosphamide
2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12.
Other Name: VectibixDrug: Nab-paclitaxel
100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes.
Other Names:Drug: Carboplatin
AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line.
Other Name: ParaplatinDrug: 5-Fluorouracil
500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
Other Names:Drug: Epirubicin
100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
Other Name: EllenceDrug: Cyclophosphamide
500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
- Pathologic Complete Response (CR) Rate [ Time Frame: Assessed after 14 weeks (following PNC and FEC preoperative chemotherapy treatment). ]Pathologic CR: No evidence of residual invasive tumor, including no residual tumor in the axillary lymph nodes.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01036087
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Naoto Ueno, MD, PHD||M.D. Anderson Cancer Center|