Clinical trial NCT01810393: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-03-13
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Preference for Either SC or IV Route of Administration According to Participant Preference Questionnaire (PPQ) Score
timeFrame: Baseline up to 6 cycles (cycle length = 21 days)
Secondary outcomes:
measure: Percentage of Participants With Adverse Events
timeFrame: approximately 4 years
measure: Percentage of Health Care Professionals With Preference for Either SC or IV Administration According to Health Care Professional Questionnaire (HCPQ) Score
timeFrame: Baseline up to 6 cycles (cycle length = 21 days)
Other outcomes:
Locations:
city: Agen
country: France
facility: Clinique Du Docteur Calabet; Cromg
city: Amiens
country: France
facility: Clinique De L Europe; Radiotherapie Chimiotherapie
city: Angers
country: France
facility: ICO Paul Papin; Oncologie Medicale.
city: Arras
country: France
facility: HOP Prive Arras Les Bonnettes; Chimiotherapie
city: Avignon
country: France
facility: Institut Sainte-Catherine; Oncologie
city: Bayonne
country: France
facility: Centre Hospitalier de La Cote Basque; Oncologie
city: Besancon
country: France
facility: HOPITAL JEAN MINJOZ; Oncologie
city: Bordeaux
country: France
facility: Institut Bergonie
city: Bourg En Bresse
country: France
facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie
city: Brest
country: France
facility: Hopital Morvan
city: Brest
country: France
facility: Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie
city: Caen
country: France
facility: Centre Francois Baclesse; Oncologie
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin; Oncologie
city: Clermont Ferrand
country: France
facility: Pole Sante Republique;Oncologie Hematologie
city: Creteil
country: France
facility: Chi De Creteil; Radiotherapie Oncologie
city: Dechy
country: France
facility: Centre Leonard De Vinci;Chimiotherapie
city: Dijon
country: France
facility: Centre Georges Francois Leclerc; Oncologie 3
city: La Roche Sur Yon
country: France
facility: CHD Les Oudairies
city: Le Coudray
country: France
facility: Ch Louis Pasteur; Oncologie
city: Le Mans
country: France
facility: Clinique Victor Hugo; Radiotherapie
city: Lille
country: France
facility: Polyclinique Du Bois; Oncologie
city: Lille
country: France
facility: Centre Oscar Lambret; Unite de Recherche Clinique
city: Lorient
country: France
facility: Ch Bretagne Sud Site Scorff; Oncologie Medicale
city: Lyon
country: France
facility: Centre Leon Berard
city: Lyon
country: France
facility: Clinique De La Sauvegarde; Chimiotherapie
city: Lyon
country: France
facility: Hopital Prive Jean Mermoz
city: Marseille
country: France
facility: Institut Paoli Calmettes; Oncologie Medicale
city: Melz
country: France
facility: Hopital de Mercy ;ONCOLOGIE MEDICALE
city: Metz
country: France
facility: Hopital Belle Isle; Oncologie Hematologie
city: Montpellier
country: France
facility: Clinique Clementville; Hopital De Jour
city: Nancy
country: France
facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
city: Nantes
country: France
facility: Centre Catherine de Sienne; Chimiotherapie
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nimes
country: France
facility: Institut de cancerologie du Gard
city: Orleans
country: France
facility: HOPITAL DE LA SOURCE; Service de Cardiologie, Point Jaune
city: Paris
country: France
facility: APHP - Hopital de la Pitie Salpetriere
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses
city: Paris
country: France
facility: Institut Curie; Oncologie Medicale
city: Paris
country: France
facility: Hopital Saint Louis; Oncologie Medicale
city: Paris
country: France
facility: HOPITAL TENON; Cancerologie Medicale
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers cedex
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Pringy
country: France
facility: CH d'Annecy
city: Quimper
country: France
facility: Chi De Cornouaille; Oncologie Hospitalisation
city: Reims CEDEX
country: France
facility: Institut Jean Godinot; Oncologie Medicale
city: Reims
country: France
facility: Institut du Cancer Coulancy Reims
city: Rennes
country: France
facility: Centre Eugene Marquis; Bureau D Etudes Cliniques
city: Rouen
country: France
facility: Centre Henri Becquerel; Oncologie Medicale
city: Saint Gregoire
country: France
facility: Chp Saint Gregoire; Cancerologie Radiotherapie
city: Saint Herblain
country: France
facility: Centre Rene Gauducheau
city: Saint Jean de Luz
country: France
facility: Polyclinique de la Cote Basque Sud; Oncologie
city: Saint Nazaire
country: France
facility: Clinique Mutualiste L Estuaire
city: Saint Quentin
country: France
facility: CH de Saint Quentin
city: Sarcelles
country: France
facility: Hopital Prive Nord Parisien; Soins De Suite - Oncologie
city: St Martin Boulogne
country: France
facility: CMCO De La Cote D Opale; Auberge De Jour
city: St-Priest-En-Jarez
country: France
facility: Institut de Cancérologie de Loire
city: Strasbourg
country: France
facility: Clinique Ste Anne
city: Strasbourg
country: France
facility: Centre Paul Strauss; Oncologie Medicale
city: Strasbourg
country: France
facility: Hopital de Hautepierre
city: Toulouse
country: France
facility: Hôpital Rangueil - CHU de Toulouse
city: Toulouse
country: France
facility: Clinique Pasteur; Oncologie Medicale
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Pivot X, Spano JP, Espie M, Cottu P, Jouannaud C, Pottier V, Moreau L, Extra JM, Lortholary A, Rivera P, Spaeth D, Attar-Rabia H, Benkanoun C, Dima-Martinez L, Esposito N, Gligorov J. Patients' preference of trastuzumab administration (subcutaneous versus intravenous) in HER2-positive metastatic breast cancer: Results of the randomised MetaspHer study. Eur J Cancer. 2017 Sep;82:230-236. doi: 10.1016/j.ejca.2017.05.009. Epub 2017 Jun 23.