Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01036087|
Recruitment Status : Active, not recruiting
First Posted : December 21, 2009
Last Update Posted : April 28, 2017
|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 2018|
|Estimated Study Completion Date :||November 2018|
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.
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): 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|