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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • 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 Bergonié
      • 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
        • Hopital Prive 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 - Hôpital de la Pitié Salpétrière
      • 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 René 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
        • Hopital 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

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
Intervention / Treatment
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

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

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

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)

June 11, 2013

Primary Completion (Actual)

July 17, 2019

Study Completion (Actual)

July 17, 2019

Study Registration Dates

First Submitted

March 11, 2013

First Submitted That Met QC Criteria

March 11, 2013

First Posted (Estimate)

March 13, 2013

Study Record Updates

Last Update Posted (Actual)

September 4, 2020

Last Update Submitted That Met QC Criteria

September 3, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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