Completed

An Open-Label, Randomized, Multicenter Phase III Study in Patients With HER2-Positive Metastatic Breast Cancer Responding to First Line Treatment With Intravenous Trastuzumab for at Least 3 Years and Investigating Patient Preference for Subcutaneous Trastuzumab

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What is being tested

Trastuzumab

+ Trastuzumab

Drug
Who is being recruted

Breast Diseases+3

+ Neoplasms

+ Neoplasms by Site

Over 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 2013
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: September 4, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: June 11, 2013

Actual date on which the first participant was enrolled.

This open-label, randomized, multicenter study will evaluate participant preference for subcutaneous (SC) versus intravenous (IV) trastuzumab (Herceptin) in participants with HER2-positive metastatic breast cancer responding to first-line treatment with IV trastuzumab for at least 3 years. Participants will be randomized to receive either 3 cycles (cycle length = 21 days) of trastuzumab SC followed by 3 cycles of trastuzumab IV or 3 cycles of trastuzumab IV followed by 3 cycles of trastuzumab SC. All participants will receive trastuzumab SC for Cycles 7 to 18. Anticipated time on study treatment is 1 year or until disease progression or inacceptable toxicity occurs, whichever comes first.

NCT01810393
Principal SponsorHoffmann-La Roche
Last updated: September 4, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

114 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast Neoplasms

Criteria

5 inclusion criteria required to participate
Histologically or cytologically confirmed HER2-positive metastatic breast cancer
Hormonal therapy will be allowed
Left ventricular ejection fraction (LVEF) of greater than or equal to ( >= ) 50 percent (%)
On treatment with first-line trastuzumab IV and free of disease progression for at least 3 years
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9 exclusion criteria prevent from participating
Central nervous system metastases, unless they have been treated and have been stable for at least 3 years
Concurrent enrollment in an other clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
Hepatitis B, hepatitis C or human immunodeficiency virus infection
History of other malignancy, except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively treated malignancies who have been disease-free for at least 5 years; participants with previous ductal carcinoma in situ of the breast are also eligible
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive treatment with Trastuzumab IV for the first 3 cycles (cycle length = 21 days) followed by Trastuzumab SC for the next 3 cycles. Participants will continue receiving treatment with trastuzumab SC for another 12 cycles (if SC treatment is well tolerated, otherwise participants will continue IV treatment) for a total of 18 cycles of treatment during the study.

Group II

Experimental
Participants will receive treatment with Trastuzumab SC for the first 3 cycles (cycle length = 21 days) followed by Trastuzumab IV for the next 3 cycles. Participants will continue receiving treatment with trastuzumab SC for another 12 cycles (if SC treatment is well tolerated, otherwise participants will continue IV treatment) for a total of 18 cycles of treatment during the study.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 61 locations

Clinique Du Docteur Calabet; Cromg

Agen, FranceOpen Clinique Du Docteur Calabet; Cromg in Google Maps

Clinique De L Europe; Radiotherapie Chimiotherapie

Amiens, France

ICO Paul Papin; Oncologie Medicale.

Angers, France

HOP Prive Arras Les Bonnettes; Chimiotherapie

Arras, France
Completed61 Study Centers