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Eine Studie zu Atezolizumab in Kombination mit Nab-Paclitaxel im Vergleich zu Placebo mit Nab-Paclitaxel bei Patientinnen mit zuvor unbehandeltem metastasierendem, dreifach negativem Brustkrebs (IMpassion130)
A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)
- Krebs
- Brustkrebs
- Triple-negatives Mammakarzinom
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:
Aktiv, keine Rekrutierung
Diese Studie läuft in
Städte
- Berlin
- Dortmund
- Dresden
- Erlangen
- Essen
- Georgsmarienhütte
- Halle
- Hamburg
- Hannover
- Heidelberg
- Koblenz
- Köln
- Lübeck
- Magdeburg
- München
- Münster
- Nordhausen
- Recklinghausen
- Rostock
- Trier
- Troisdorf
- Tübingen
Studien-ID:
NCT02425891 2014-005490-37 WO29522
Studienzusammenfassung
This multicenter, randomized, double-blind study will evaluate the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT02425891,WO29522,2014-005490-37
Studien-ID
Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody, Nab-Paclitaxel, Placebo
Treatments
Triple Negative Breast Cancer
Condition
Official Title
A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer
Einschlusskriterien
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Metastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression
- No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
- Eligible for taxane monotherapy (i.e., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control)
- A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 20 unstained slides with an associated pathology report documenting ER, PR, and HER2 negativity. Participants with fewer than 20 unstained slides available at baseline, and not fewer than 12 unstained slides will be eligible upon discussion with Medical Monitor
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Measurable disease as defined by RECIST v1.1
- Adequate hematologic and end-organ function
Exclusion Criteria
- Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
- Leptomeningeal disease
- Pregnancy or lactation
- History of autoimmune disease
- Prior allogeneic stem cell or solid organ transplantation
- Positive test for human immunodeficiency virus
- Active hepatitis B or hepatitis C
- Receipt of a live, attenuated vaccine within 4 weeks prior to randomization, during treatment, or within 5 months following the last dose of atezolizumab/placebo
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