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Eine Studie zur Sicherheit und Verträglichkeit von Herceptin (Trastuzumab), das durch eine assistierte Injektion oder durch Selbstinjektion subkutan verabreicht wird, als adjuvante Therapie bei Patientinnen mit HER2-positivem Brustkrebs im Frühstadium (HER2: humaner epidermaler Wachstumsfaktor-Rezeptor 2)
A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer (SafeHER)
- Krebs
- Brustkrebs
- Brustkrebs, Her2-positiv
- Breast Neoplasms
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Abgeschlossen
Diese Studie läuft in
Städte
- Augsburg
- Bad Soden am Taunus
- Berlin
- Bielefeld
- Bochum
- Deggendorf
- Essen
- Freiburg im Breisgau
- Georgsmarienhütte
- Halle (Saale)
- Hamburg
- Hannover
- Heidelberg
- Jena
- Kassel
- Kulmbach
- Köln
- Langen (Hessen)
- Leverkusen
- Ludwigsburg
- Lübeck
- Mainz
- Marburg
- Meiningen
- Memmingen
- Minden
- Mühlhausen Thüringen
- München
- Münster
- Neuruppin
- Nürnberg
- Offenbach am Main
- Ostfildern
- Recklinghausen
- Rotenburg (Wümme)
- Saarbrücken
- Schweinfurt
- Schwerin
- Stendal
- Torgau
- Tübingen
- Unna
- Weinheim
- Weißenfels
- Wetzlar
- Würselen
Studien-ID:
NCT01566721 2011-005328-17 MO28048
Studienzusammenfassung
This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT01566721, MO28048, 2011-005328-17
Studien-ID
Herceptin
Treatments
Breast Neoplasms
Condition
Official Title
A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer
Einschlusskriterien
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Histologically confirmed early invasive HER2-positive carcinoma of the breast with no evidence of residual, locally recurrent, or metastatic disease and defined as clinical Stage I to IIIC that is eligible for treatment with Herceptin
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Screening left ventricular ejection fraction (LVEF) greater than or equal to (≥) 55%
Exclusion Criteria
- Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent
- History of other malignancy except for curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or curatively treated malignancies (other than breast cancer) where the participant has been disease-free for at least 5 years
- Past history of ductal carcinoma in situ treated with any systemic therapy or with radiation therapy to the ipsilateral breast where invasive cancer subsequently developed
- Metastatic disease
- Inadequate bone marrow, hepatic, or renal function
- Serious cardiac or cardiovascular disease including uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy
- History of severe allergic or immunological reactions, such as difficult-to-control asthma
- Pregnant or lactating women
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