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Eine Studie zu Pertuzumab in Kombination mit Trastuzumab (Herceptin) und einem Taxan in der Erstlinientherapie von Teilnehmerinnen mit fortgeschrittenem HER2-positivem Brustkrebs (HER2: humaner epidermaler Wachstumsfaktor-Rezeptor 2)
A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer (PERUSE)
- 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
- Bamberg
- Bremen
- Erlangen
- Essen
- Esslingen am Neckar
- Frankfurt am Main
- Gera
- Hamburg
- Hannover
- Heidelberg
- Homburg
- Limburg an der Lahn
- Lübeck
- Mönchengladbach
- München
- Neuruppin
- Rotenburg (Wümme)
- Saarbrücken
- Torgau
- Tübingen
Studien-ID:
NCT01572038 2011-005334-20 MO28047
Studienzusammenfassung
This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT01572038, MO28047, 2011-005334-20
Studien-ID
Docetaxel, Nab-paclitaxel, Paclitaxel, Pertuzumab, Trastuzumab
Treatments
Breast Neoplasms
Condition
Official Title
A Multicenter, Open-Label, Single-Arm Study of Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2-Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer
Einschlusskriterien
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection
- HER2-positive breast cancer
- Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- LVEF of at least 50 percent (%)
Exclusion Criteria
- Previous systemic non-hormonal anti-cancer therapy for metastatic or locally recurrent disease
- Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence less than or equal to (</=) 6 months
- Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
- Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
- History of persistent Grade 2 or higher (National Cancer Institute Common Toxicity Criteria [NCI-CTC], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
- Central nervous system (CNS) metastases
- Current peripheral neuropathy of Grade 3 or greater (NCI-CTC, version 4.0)
- History of other malignancy within the last 5 years prior to first study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma
- Inadequate bone marrow, liver or renal function
- Uncontrolled hypertension
- Hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection
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