NCT01855828

Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main goal of this clinical trial is to test if adding pertuzumab (Perjeta), improves the anticancer activity of the combination chemotherapy regimen of trastuzumab (Herceptin) concomitant with paclitaxel, 5-fluorouracil, epirubicin, and cyclophosphamide (T-FEC). The study will also test the safety of this therapy.

Detailed description

Subjects will receive 6 months of T-FEC chemotherapy concomitant with trastuzumab and pertuzumab before surgery. Subsequently, subjects will undergo surgery to remove any cancer from the breast and axillary lymph nodes that may have survived the chemotherapy. It is expected that the majority of women will have no viable cancer left in the breast or lymph nodes by the time all chemotherapy is completed.

Conditions

• Her2-Positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Pertuzumab	First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
DRUG	Trastuzumab	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).
DRUG	Paclitaxel	Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
DRUG	5-fluorouracil	Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
DRUG	Epirubicin	Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
DRUG	Cyclophosphamide	Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).

Timeline

• Start date: 2013-09-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2013-05-17
• Last updated: 2020-03-31
• Results posted: 2020-03-31

Locations

1 site across 1 country: United States