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A Study Evaluating Pertuzumab (Perjeta) Combined With Trastuzumab (Herceptin) and Standard Anthracycline-based Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced, Inflammatory, or Early-stage Breast Cancer

NCT02132949 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 401

Last updated 2021-09-17

Study results available
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Summary

This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and anthracycline-based chemotherapy as neoadjuvant treatment in participants with HER2-positive locally advanced, inflammatory, or early-stage breast cancer. Each investigator will choose a treatment regimen (A or B) for all of their participants to follow. Treatment regimen A (for Cohort A) will include dose-dense doxorubicin and cyclophosphamide (ddAC), followed by paclitaxel, with pertuzumab and trastuzumab given from the start of paclitaxel. Treatment regimen B (for Cohort B) will include 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), followed by docetaxel, with pertuzumab and trastuzumab given from the start of docetaxel. Participants in both cohorts will subsequently undergo surgical treatment and then resume pertuzumab and trastuzumab treatment.

Conditions

Interventions

DRUG

5-Fluorouracil

Participants will receive 5-fluorouracil 500 mg/m\^2 IV on Day 1 of each cycle q3w.

DRUG

Cyclophosphamide

Participants will receive cyclophosphamide 600 milligrams per square meter (mg/m\^2) intravenous (IV) given on Day 1 of each cycle q2w.

DRUG

Docetaxel

Participants will receive docetaxel at a starting dose of 75 mg/m\^2 IV for the first cycle and the dose may be escalated to 100 mg/m\^2 for subsequent cycles q3w.

DRUG

Doxorubicin

Participants will receive doxorubicin 60 mg/m\^2 IV on Day 1 of each cycle q2w.

DRUG

Epirubicin

Participants will receive epirubicin 100 mg/m\^2 IV on Day 1 of each cycle q3w.

DRUG

Paclitaxel

Participants will receive paclitaxel 80 mg/m\^2 IV given weekly.

DRUG

Pertuzumab

Participants will receive pertuzumab at a loading dose of 840 milligrams (mg) IV loading dose, then 420 mg IV q3w.

DRUG

Trastuzumab

Participants will receive trastuzumab at a loading dose of 8 milligrams per kilogram (mg/kg) IV, then 6 mg/kg IV q3w.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-14
Primary Completion
2016-03-03
Completion
2020-08-25
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Mexico
  • Norway
  • Poland
  • Portugal
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT02132949 on ClinicalTrials.gov