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Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer

NCT01937117 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-07-01

Study results available
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Summary

This research is being done to determine if early changes on a type of imaging procedure called PET (Positron Emission Tomography) can predict which patients are most likely to respond to the combination of trastuzumab and pertuzumab when given prior to surgery.

Conditions

Interventions

PROCEDURE

Positron emission tomography (PET)

PET will be performed at baseline and on day 15

DRUG

Trastuzumab

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

DRUG

Pertuzumab

840 mg as a loading dose, then 420 mg every 3 weeks, IV

Sponsors & Collaborators

  • Translational Breast Cancer Research Consortium

    collaborator OTHER

  • Genentech, Inc.

    collaborator INDUSTRY

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Roisin Connolly, MBBCh · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-30
Primary Completion
2018-03-20
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT01937117 on ClinicalTrials.gov