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A Study of Subcutaneously Administered Herceptin (Trastuzumab) in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer

NCT01928615 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2014-09-29

Study results available
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Summary

This open-label, randomized crossover study evaluated the quality of life, efficacy, and safety of subcutaneous Herceptin (trastuzumab) injected either into the thigh or the upper arm of participants with early HER2-positive breast cancer.

Conditions

Interventions

DRUG

Trastuzumab - intravenous solution

Trastuzumab was supplied as a powder to be reconstituted as a solution for intravenous infusion.

DRUG

Trastuzumab - subcutaneous solution

Trastuzumab was supplied as a solution for subcutaneous injection.

DRUG

Chemotherapy

Standard chemotherapy for early breast cancer.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Austria

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 NCT01928615 on ClinicalTrials.gov