Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer
|ClinicalTrials.gov Identifier: NCT01855828|
Recruitment Status : Active, not recruiting
First Posted : May 17, 2013
Last Update Posted : January 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Her2-Positive Breast Cancer||Drug: Pertuzumab Drug: Trastuzumab Drug: Paclitaxel Drug: 5-fluorouracil Drug: Epirubicin Drug: Cyclophosphamide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single Arm, Neoadjuvant, Phase II Trial of Pertuzumab and Trastuzumab Administered Concomitantly With Weekly Paclitaxel and FEC for Clinical Stage I-II HER2-Positive Breast Cancer|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Chemo plus Pertuzumab,Trastuzumab
During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).
First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
Other Name: Perjeta
For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).
For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).
Other Name: Herceptin
Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
Other Name: Taxol
Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Other Name: 5-FU
Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
Other Name: Ellence
Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Other Name: Cytoxan
- Pathologic Complete Response [ Time Frame: 3 years ]To estimate the pathologic complete response rate (pCR) when pertuzumab is added to weekly trastuzumab/paclitaxel followed by trastuzumab/5-fluorouracil, epirubicin and cyclophosphamide neoadjuvant chemotherapy in HER2-positive breast cancer. This study will assess pCR rates separately in ER+ and ER- cancers. Pathologic complete response is defined as no evidence of viable invasive tumor cells at the primary tumor site and axillary lymph nodes in the surgical specimen. Residual Disease (RD) is defined as: Any invasive cancer in the breast or axillary lymph nodes in the surgical specimen.
- Safety [ Time Frame: 3 years ]
1. To assess the safety and tolerability of the regimen.
- Assess cardiac safety measured by rates of clinically symptomatic congestive heart failure, asymptomatic decrease in LVEF >10%, and decrease of LVEF below normal level.
- Assess general tolerability measured by the standard NCI Common Toxicity Criteria.
- Clinical Response [ Time Frame: 3 years ]To assess clinical response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Residual Cancer burden score [ Time Frame: 3 years ]To assess Residual Cancer Burden score and to collect pre-treatment and residual cancer tissue after completion of chemotherapy for correlative science studies.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855828
|United States, Connecticut|
|Yale University Smilow Cancer Hospital|
|New Haven, Connecticut, United States, 06520|
|Principal Investigator:||Lajos Pusztai, MD||Yale University|