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

NCT01855828 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-03-31

Study results available
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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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • Lajos Pusztai, MD · Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01855828 on ClinicalTrials.gov