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
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
2 other identifiers
interventional
114
1 country
61
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 breast-cancer
Started Jun 2013
Typical duration for phase_3 breast-cancer
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2013
CompletedFirst Posted
Study publicly available on registry
March 13, 2013
CompletedStudy Start
First participant enrolled
June 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2019
CompletedSeptember 4, 2020
September 1, 2020
6.1 years
March 11, 2013
September 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Percentage of Participants With Adverse Events
approximately 4 years
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)
Study Arms (2)
Trastuzumab IV Then Trastuzumab SC
EXPERIMENTALParticipants 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.
Trastuzumab SC Then Trastuzumab IV
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
Clinique Du Docteur Calabet; Cromg
Agen, 47000, France
Clinique De L Europe; Radiotherapie Chimiotherapie
Amiens, 80090, France
ICO Paul Papin; Oncologie Medicale.
Angers, 49055, France
HOP Prive Arras Les Bonnettes; Chimiotherapie
Arras, 62012, France
Institut Sainte-Catherine; Oncologie
Avignon, 84082, France
Centre Hospitalier de La Cote Basque; Oncologie
Bayonne, 64109, France
HOPITAL JEAN MINJOZ; Oncologie
Besançon, 25030, France
Institut Bergonie
Bordeaux, 33076, France
Centre Hospitalier Fleyriat; Oncologie/Hematologie
Bourg-en-Bresse, 01012, France
Hopital Morvan
Brest, 29200, France
Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie
Brest, 29220, France
Centre Francois Baclesse; Oncologie
Caen, 14076, France
Centre Jean Perrin; Oncologie
Clermont-Ferrand, 63011, France
Pole Sante Republique;Oncologie Hematologie
Clermont-Ferrand, 63050, France
Chi De Creteil; Radiotherapie Oncologie
Créteil, 94010, France
Centre Leonard De Vinci;Chimiotherapie
Dechy, 59187, France
Centre Georges Francois Leclerc; Oncologie 3
Dijon, 21079, France
CHD Les Oudairies
La Roche-sur-Yon, 85925, France
Ch Louis Pasteur; Oncologie
Le Coudray, 28630, France
Clinique Victor Hugo; Radiotherapie
Le Mans, 72015, France
Polyclinique Du Bois; Oncologie
Lille, 59003, France
Centre Oscar Lambret; Unite de Recherche Clinique
Lille, 59020, France
Ch Bretagne Sud Site Scorff; Oncologie Medicale
Lorient, 56100, France
Centre Leon Berard
Lyon, 69008, France
Clinique De La Sauvegarde; Chimiotherapie
Lyon, 69337, France
Hopital Prive Jean Mermoz
Lyon, 69373, France
Institut Paoli Calmettes; Oncologie Medicale
Marseille, 13273, France
Hopital de Mercy ;ONCOLOGIE MEDICALE
Melz-sur-Seine, 57085, France
Hopital Belle Isle; Oncologie Hematologie
Metz, 57045, France
Clinique Clementville; Hopital De Jour
Montpellier, 34070, France
Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
Nancy, 54100, France
Centre Catherine de Sienne; Chimiotherapie
Nantes, 44202, France
Centre Antoine Lacassagne
Nice, 06189, France
Institut de cancerologie du Gard
Nîmes, 30029, France
HOPITAL DE LA SOURCE; Service de Cardiologie, Point Jaune
Orléans, 45100, France
APHP - Hopital de la Pitie Salpetriere
Paris, 75013, France
Groupe Hospitalier Diaconesses
Paris, 75020, France
Institut Curie; Oncologie Medicale
Paris, 75231, France
Hopital Saint Louis; Oncologie Medicale
Paris, 75475, France
HOPITAL TENON; Cancerologie Medicale
Paris, 75970, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021, France
CH d'Annecy
Pringy, 74370, France
Chi De Cornouaille; Oncologie Hospitalisation
Quimper, 29107, France
Institut Jean Godinot; Oncologie Medicale
Reims, 51056, France
Institut du Cancer Coulancy Reims
Reims, 51100, France
Centre Eugene Marquis; Bureau D Etudes Cliniques
Rennes, 35042, France
Centre Henri Becquerel; Oncologie Medicale
Rouen, 76038, France
Chp Saint Gregoire; Cancerologie Radiotherapie
Saint-Grégoire, 35768, France
Centre Rene Gauducheau
Saint-Herblain, 44805, France
Polyclinique de la Cote Basque Sud; Oncologie
Saint-Jean-de-Luz, 64501, France
CMCO De La Cote D Opale; Auberge De Jour
Saint-Martin-Boulogne, 62280, France
Clinique Mutualiste L Estuaire
Saint-Nazaire, 44606, France
Institut de Cancérologie de Loire
Saint-Priest-en-Jarez, 42271, France
CH de Saint Quentin
Saint-Quentin, 2100, France
Hopital Prive Nord Parisien; Soins De Suite - Oncologie
Sarcelles, 95200, France
Clinique Ste Anne
Strasbourg, 67000, France
Centre Paul Strauss; Oncologie Medicale
Strasbourg, 67065, France
Hopital de Hautepierre
Strasbourg, 67091, France
Hôpital Rangueil - CHU de Toulouse
Toulouse, 31059, France
Clinique Pasteur; Oncologie Medicale
Toulouse, 31076, France
Related Publications (1)
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.
PMID: 28648618DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2013
First Posted
March 13, 2013
Study Start
June 11, 2013
Primary Completion
July 17, 2019
Study Completion
July 17, 2019
Last Updated
September 4, 2020
Record last verified: 2020-09