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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01810393
• Other study ID #: ML28589
• Secondary ID: 2012-003442-32
• Status: Completed
• Phase: Phase 3
• Start date: June 11, 2013
• Est. completion date: July 17, 2019

Study information

• Verified date: September 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: July 17, 2019
• Est. primary completion date: July 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Clinique Du Docteur Calabet; Cromg	Agen
France	Clinique De L Europe; Radiotherapie Chimiotherapie	Amiens
France	ICO Paul Papin; Oncologie Medicale.	Angers
France	HOP Prive Arras Les Bonnettes; Chimiotherapie	Arras
France	Institut Sainte-Catherine; Oncologie	Avignon
France	Centre Hospitalier de La Cote Basque; Oncologie	Bayonne
France	HOPITAL JEAN MINJOZ; Oncologie	Besancon
France	Institut Bergonie	Bordeaux
France	Centre Hospitalier Fleyriat; Oncologie/Hematologie	Bourg En Bresse
France	Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie	Brest
France	Hopital Morvan	Brest
France	Centre Francois Baclesse; Oncologie	Caen
France	Centre Jean Perrin; Oncologie	Clermont Ferrand
France	Pole Sante Republique;Oncologie Hematologie	Clermont Ferrand
France	Chi De Creteil; Radiotherapie Oncologie	Creteil
France	Centre Leonard De Vinci;Chimiotherapie	Dechy
France	Centre Georges Francois Leclerc; Oncologie 3	Dijon
France	CHD Les Oudairies	La Roche Sur Yon
France	Ch Louis Pasteur; Oncologie	Le Coudray
France	Clinique Victor Hugo; Radiotherapie	Le Mans
France	Centre Oscar Lambret; Unite de Recherche Clinique	Lille
France	Polyclinique Du Bois; Oncologie	Lille
France	Ch Bretagne Sud Site Scorff; Oncologie Medicale	Lorient
France	Centre Leon Berard	Lyon
France	Clinique De La Sauvegarde; Chimiotherapie	Lyon
France	Hopital Prive Jean Mermoz	Lyon
France	Institut Paoli Calmettes; Oncologie Medicale	Marseille
France	Hopital de Mercy ;ONCOLOGIE MEDICALE	Melz
France	Hopital Belle Isle; Oncologie Hematologie	Metz
France	Clinique Clementville; Hopital De Jour	Montpellier
France	Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE	Nancy
France	Centre Catherine de Sienne; Chimiotherapie	Nantes
France	Centre Antoine Lacassagne	Nice
France	Institut de cancerologie du Gard	Nimes
France	HOPITAL DE LA SOURCE; Service de Cardiologie, Point Jaune	Orleans
France	APHP - Hopital de la Pitie Salpetriere	Paris
France	Groupe Hospitalier Diaconesses	Paris
France	Hopital Saint Louis; Oncologie Medicale	Paris
France	HOPITAL TENON; Cancerologie Medicale	Paris
France	Institut Curie; Oncologie Medicale	Paris
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	Centre Hospitalier Universitaire de Poitiers	Poitiers cedex
France	CH d'Annecy	Pringy
France	Chi De Cornouaille; Oncologie Hospitalisation	Quimper
France	Institut du Cancer Coulancy Reims	Reims
France	Institut Jean Godinot; Oncologie Medicale	Reims CEDEX
France	Centre Eugene Marquis; Bureau D Etudes Cliniques	Rennes
France	Centre Henri Becquerel; Oncologie Medicale	Rouen
France	Chp Saint Gregoire; Cancerologie Radiotherapie	Saint Gregoire
France	Centre Rene Gauducheau	Saint Herblain
France	Polyclinique de la Cote Basque Sud; Oncologie	Saint Jean de Luz
France	Clinique Mutualiste L Estuaire	Saint Nazaire
France	CH de Saint Quentin	Saint Quentin
France	Hopital Prive Nord Parisien; Soins De Suite - Oncologie	Sarcelles
France	CMCO De La Cote D Opale; Auberge De Jour	St Martin Boulogne
France	Institut de Cancérologie de Loire	St-Priest-En-Jarez
France	Centre Paul Strauss; Oncologie Medicale	Strasbourg
France	Clinique Ste Anne	Strasbourg
France	Hopital de Hautepierre	Strasbourg
France	Clinique Pasteur; Oncologie Medicale	Toulouse
France	Hôpital Rangueil - CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Preference for Either SC or IV Route of Administration According to Participant Preference Questionnaire (PPQ) Score		Baseline up to 6 cycles (cycle length = 21 days)
Secondary	Percentage of Participants With Adverse Events		approximately 4 years
Secondary	Percentage of Health Care Professionals With Preference for Either SC or IV Administration According to Health Care Professional Questionnaire (HCPQ) Score		Baseline up to 6 cycles (cycle length = 21 days)