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A Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

NCT02131064 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2019-07-02

Study results available
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Summary

This is a randomized, multicenter, open-label, two-arm study in treatment-naive participants with operable, locally advanced, or inflammatory, centrally-assessed HER2-positive early breast cancer (EBC) whose primary tumors were greater than or equal to (\>/=) 2 centimeters (cm). The study was designed to evaluate the efficacy and safety of trastuzumab emtansine + pertuzumab (experimental arm; T-DM1 + P) versus chemotherapy, trastuzumab + pertuzumab (control arm; TCH + P). The study comprised a neoadjuvant treatment period, followed by surgery, and an adjuvant treatment period.

Treatment can be stopped due to disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Carboplatin

Carboplatin IV infusion at a dose to achieve an AUC of 6 mg\*min/mL q3w

DRUG

Docetaxel

Docetaxel 75 mg/m\^2 IV infusion q3w

DRUG

Pertuzumab

Pertuzumab 840 mg (loading dose); and 420 mg (maintenance dose) IV infusion q3w

DRUG

Trastuzumab

Trastuzumab 8 mg/kg (loading dose); and 6 mg/kg (maintenance dose) IV infusion q3w

DRUG

Trastuzumab Emtansine

Trastuzumab Emtansine 3.6 mg/kg IV infusion q3w

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
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-25
Primary Completion
2015-12-31
Completion
2018-05-29

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
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 NCT02131064 on ClinicalTrials.gov