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A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer

NCT00976989 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2017-02-06

Study results available
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Summary

This 3 arm study will assess the tolerability, safety and efficacy of 3 neoadjuvant treatment regimens in participants with locally advanced, inflammatory or early stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Before surgery, participants will be randomized to receive either A) 6 cycles of pertuzumab plus trastuzumab (Herceptin), with 5-fluorouracil/epirubicin/cyclophosphamide (FEC) for cycles 1-3 and docetaxel for cycles 4-6, or B) FEC for cycles 1-3 followed by pertuzumab plus trastuzumab with docetaxel for cycles 4-6, or C) 6 cycles of pertuzumab plus trastuzumab with docetaxel and carboplatin. Pertuzumab will be administered at a loading dose of 840 mg intravenously (iv), then 420 mg iv 3-weekly, trastuzumab at a loading dose of 8 mg/kg iv, then 6 mg/kg iv 3-weekly, docetaxel at 75 mg/m\^2 iv, increased to 100 mg/m\^2 iv 3-weekly, and FEC and carboplatin iv 3-weekly at standard doses. Following surgery participants will receive trastuzumab 6 mg/kg iv 3-weekly for a total of 1 year, as well as adequate chemo-, radio- and hormone therapy. Anticipated time on study treatment is 4-12 months, and target sample size is 200-300.

Conditions

Interventions

DRUG

Pertuzumab

840 mg loading dose intravenously (IV), then 420 mg IV 3-weekly.

DRUG

Trastuzumab

8 mg/kg loading dose IV, then 6 mg/kg every 3 weeks.

DRUG

FEC

5-fluorouracil 500 mg/m\^2, epirubicin 100 mg/m\^2 and cyclophosphamide 600 mg/m\^2.

DRUG

Docetaxel

75 mg/m\^2 for the first dose; 100 mg/m\^2 if no dose limiting toxicity occurs.

DRUG

TCH

Trastuzumab followed by carboplatin at target area under the plasma concentration-time curve (AUC) 6 and docetaxel at a starting dose of 75 mg/m\^2. All treatments were given every three weeks by the IV route.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-06-30
Completion
2016-01-31

Countries

  • Bosnia and Herzegovina
  • Brazil
  • Canada
  • Croatia
  • Germany
  • Greece
  • Italy
  • Mexico
  • New Zealand
  • Portugal
  • Romania
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • The Bahamas
  • United Kingdom

Study Locations

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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 NCT00976989 on ClinicalTrials.gov