A Study to Assess Preference for Subcutaneous Trastuzumab Treatment in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Metastatic Breast Cancer Responding to First-Line Intravenous Trastuzumab for at Least 3 Years

September 3, 2020 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Agen, France, 47000
        • Clinique Du Docteur Calabet; Cromg
      • Amiens, France, 80090
        • Clinique De L Europe; Radiotherapie Chimiotherapie
      • Angers, France, 49055
        • ICO Paul Papin; Oncologie Medicale.
      • Arras, France, 62012
        • HOP Prive Arras Les Bonnettes; Chimiotherapie
      • Avignon, France, 84082
        • Institut Sainte-Catherine; Oncologie
      • Bayonne, France, 64109
        • Centre Hospitalier de La Cote Basque; Oncologie
      • Besancon, France, 25030
        • HOPITAL JEAN MINJOZ; Oncologie
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Bourg En Bresse, France, 01012
        • Centre Hospitalier Fleyriat; Oncologie/Hematologie
      • Brest, France, 29200
        • Hopital Morvan
      • Brest, France, 29220
        • Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie
      • Caen, France, 14076
        • Centre Francois Baclesse; Oncologie
      • Clermont Ferrand, France, 63011
        • Centre Jean Perrin; Oncologie
      • Clermont Ferrand, France, 63050
        • Pole Sante Republique;Oncologie Hematologie
      • Creteil, France, 94010
        • Chi De Creteil; Radiotherapie Oncologie
      • Dechy, France, 59187
        • Centre Leonard De Vinci;Chimiotherapie
      • Dijon, France, 21079
        • Centre Georges Francois Leclerc; Oncologie 3
      • La Roche Sur Yon, France, 85925
        • CHD les Oudairies
      • Le Coudray, France, 28630
        • Ch Louis Pasteur; Oncologie
      • Le Mans, France, 72015
        • Clinique Victor Hugo; Radiotherapie
      • Lille, France, 59003
        • Polyclinique Du Bois; Oncologie
      • Lille, France, 59020
        • Centre Oscar Lambret; Unite de Recherche Clinique
      • Lorient, France, 56100
        • Ch Bretagne Sud Site Scorff; Oncologie Medicale
      • Lyon, France, 69008
        • Centre Léon Bérard
      • Lyon, France, 69373
        • Hôpital privé Jean Mermoz
      • Lyon, France, 69337
        • Clinique De La Sauvegarde; Chimiotherapie
      • Marseille, France, 13273
        • Institut Paoli Calmettes; Oncologie Medicale
      • Melz, France, 57085
        • Hopital de Mercy ;ONCOLOGIE MEDICALE
      • Metz, France, 57045
        • Hopital Belle Isle; Oncologie Hematologie
      • Montpellier, France, 34070
        • Clinique Clementville; Hopital De Jour
      • Nancy, France, 54100
        • Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
      • Nantes, France, 44202
        • Centre Catherine de Sienne; Chimiotherapie
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Nimes, France, 30029
        • Institut de cancerologie du Gard
      • Orleans, France, 45100
        • HOPITAL DE LA SOURCE; Service de Cardiologie, Point Jaune
      • Paris, France, 75231
        • Institut Curie; Oncologie Medicale
      • Paris, France, 75970
        • HOPITAL TENON; Cancerologie Medicale
      • Paris, France, 75475
        • Hopital Saint Louis; Oncologie Medicale
      • Paris, France, 75013
        • APHP - Hopital de la Pitie Salpetriere
      • Paris, France, 75020
        • Groupe Hospitalier Diaconesses
      • Pierre Benite, France, 69495
        • Centre Hospitalier LYON SUD
      • Poitiers cedex, France, 86021
        • Centre Hospitalier Universitaire de Poitiers
      • Pringy, France, 74370
        • CH d'Annecy
      • Quimper, France, 29107
        • Chi De Cornouaille; Oncologie Hospitalisation
      • Reims, France, 51100
        • Institut du Cancer Coulancy Reims
      • Reims CEDEX, France, 51056
        • Institut Jean Godinot; Oncologie Medicale
      • Rennes, France, 35042
        • Centre Eugene Marquis; Bureau D Etudes Cliniques
      • Rouen, France, 76038
        • Centre Henri Becquerel; Oncologie Medicale
      • Saint Gregoire, France, 35768
        • Chp Saint Gregoire; Cancerologie Radiotherapie
      • Saint Herblain, France, 44805
        • Centre Rene Gauducheau
      • Saint Jean de Luz, France, 64501
        • Polyclinique de la Cote Basque Sud; Oncologie
      • Saint Nazaire, France, 44606
        • Clinique Mutualiste L Estuaire
      • Saint Quentin, France, 2100
        • CH de Saint Quentin
      • Sarcelles, France, 95200
        • Hopital Prive Nord Parisien; Soins De Suite - Oncologie
      • St Martin Boulogne, France, 62280
        • CMCO De La Cote D Opale; Auberge De Jour
      • St-Priest-En-Jarez, France, 42271
        • Institut de Cancérologie de Loire
      • Strasbourg, France, 67065
        • Centre Paul Strauss; Oncologie Medicale
      • Strasbourg, France, 67091
        • Hôpital de Hautepierre
      • Strasbourg, France, 67000
        • Clinique Ste Anne
      • Toulouse, France, 31076
        • Clinique Pasteur; Oncologie Medicale
      • Toulouse, France, 31059
        • Hôpital Rangueil - CHU de Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed HER2-positive metastatic breast cancer
  • On treatment with first-line trastuzumab IV and free of disease progression for at least 3 years
  • Left ventricular ejection fraction (LVEF) of greater than or equal to (>/=) 50 percent (%)
  • Hormonal therapy will be allowed
  • Prior use of anti-HER2 therapy will be allowed

Exclusion Criteria:

  • 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
  • Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
  • Serious cardiac illness or medical conditions that would preclude the use of trastuzumab
  • Hepatitis B, hepatitis C or human immunodeficiency virus infection
  • Pregnant or lactating women
  • 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
  • Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin including hyaluronidase or the adhesive of the subcutaneous device, or a history of severe allergic or immunological reactions, for example, difficult to control asthma
  • Central nervous system metastases, unless they have been treated and have been stable for at least 3 years
  • Inadequate organ function

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Trastuzumab IV Then Trastuzumab SC
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.
Drug: Trastuzumab
Trastuzumab will be administered at a dose of 6 milligrams per kilogram (mg/kg) IV or 600 milligrams per 5 milliliter (mg/5mL) SC in 21-day cycles as per schedule described in respective arm.
Other Names:
  • Herceptin
Experimental: Trastuzumab SC Then Trastuzumab IV
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.
Drug: Trastuzumab
Trastuzumab will be administered at a dose of 6 milligrams per kilogram (mg/kg) IV or 600 milligrams per 5 milliliter (mg/5mL) SC in 21-day cycles as per schedule described in respective arm.
Other Names:
  • Herceptin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of Participants With Preference for Either SC or IV Route of Administration According to Participant Preference Questionnaire (PPQ) Score
Time Frame: Baseline up to 6 cycles (cycle length = 21 days)
Baseline up to 6 cycles (cycle length = 21 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of Participants With Adverse Events
Time Frame: approximately 4 years
approximately 4 years
Percentage of Health Care Professionals With Preference for Either SC or IV Administration According to Health Care Professional Questionnaire (HCPQ) Score
Time Frame: Baseline up to 6 cycles (cycle length = 21 days)
Baseline up to 6 cycles (cycle length = 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 17, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 17, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML28589
  • 2012-003442-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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