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NCT02425891 | SNCTP000001838

RANDOMISIERTE, MULTIZENTRISCHE, PLACEBOKONTROLLIERTE STUDIE DER PHASE III ZU ATEZOLIZUMAB (ANTI-PD-L1-ANTIKÖRPER) IN KOMBINATION MIT NAB-PACLITAXEL IM VERGLEICH ZU PLACEBO PLUS NAB-PACLITAXEL BEI PATIENTEN MIT ZUVOR UNBEHANDELTEM METASTASIERENDEM „TRIPLE-NEGATIVEM“ BRUSTKREBS

Data source: BASEC (Imported from 25.02.2020), WHO (Imported from 23.02.2020)
Changed: 23.02.2020
Disease category: Brustkrebs, Prostatakrebs, Anderer Krebs

Brief description of trial (Source of data: BASEC)

Das Ziel dieser Studie ist es, die positiven wie auch negativen Wirkungen von Atezolizumab plus Nab-Paclitaxel mit denen von Placebo (einer inaktiven Substanz, die wie Atezolizumab aussieht) plus Nab-Paclitaxel zu vergleichen, um festzustellen, welche Vorgehensweise bei „tripple-negativem“ Brustkrebs besser wirkt. Bei der Studie erhalten die Patienten entweder Atezolizumab plus Nab-Paclitaxel oder ein Placebo plus Nab-Paclitaxel bis kein Behandlungsvorteil mehr besteht resp. bis zum Fortschreiten der Krankheit. Patienten werden nach dem Zufallsprizip in einem Verhätnis von 1:1 einem der beiden Behandlungsarme zugewiesen. Weder die Patienten noch Ihr Prüfarzt wissen, welche Behandlung sie erhalten. Falls die Sicherheit der Patienten gefährdet ist, kann der Prüfarzt in Erfahrung bringen, ob Atezolizumab oder Placebo erhalten wurde. Bei den regelmässigen Arztbesuchen wird überprüft, wie es den Patienten geht. Unter anderem wird jeweils ein Computertomographie (CT) oder Magnetresonanztomographie (MRT) gemacht. Nach Forschreiten der Krankheit werden die Patienten weiterhin beobachtet. Es werden ca. 900 Patienten in der Studie eingeschlossen. Die Studie wird weltweit in 40 Ländern druchgeführt. Die Studie wird in vollem Einklang mit allen geltenen gesetzlichen Vorschriften sowie unter ethischen Gesichtspunkten durchgeführt.

Health conditions investigated (Source of data: BASEC)

UNBEHANDELTER METASTASIERENDER „TRIPLE-NEGATIVEM“ BRUSTKREBS

Health conditions (Source of data: WHO)

Triple Negative Breast Cancer

Rare disease (Source of data: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Source of data: BASEC)

Patienten auf dem Prüfarm erhalten 840mg Atezolizumab intravenös alle 2 Wochen und Nab-Paclitaxel alle 3 Wochen mit einer Woche Pause. Patienten auf dem Placeboarm erhalten Placebo intravenös alle 2 Wochenund Nab-Paclitaxel alle 3 Wochen mit einer Woche Pause.

Interventions (Source of data: WHO)

Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody;Drug: Nab-Paclitaxel;Drug: Placebo

Criteria for participation in trial (Source of data: BASEC)

- Frauen und Männer ab 18 Jahren
- unbehandelter metastatsierter dreifach negativer Brustkrebs
- guter Allgemeinzustand

Exclusion criteria (Source of data: BASEC)

- andere Krebserkrankungen
- erhebliche Herzkreislauferkrankungen
- Schwangerschaft oder Stillende

Inclusion/Exclusion Criteria (Source of data: WHO)


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

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT02425891

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02425891

Further information on trial

Date trial registered

21.04.2015

Incorporation of the first participant

23.06.2015

Recruitment status

Active, not recruiting

Academic title (Source of data: WHO)

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

Type of trial (Source of data: WHO)

Interventional

Design of the trial (Source of data: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).

Phase (Source of data: WHO)

Phase 3

Primary end point (Source of data: WHO)

Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in all Randomized Participants;PFS According to RECIST v1.1 in Participants with Detectable Programmed Death-Ligand 1 (PD-L1);OS in Participants with Detectable PD-L1;Overall Survival (OS) in all Randomized Participants

Secundary end point (Source of data: WHO)

Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in all Randomized Participants;Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants with Detectable PD-L1;Duration of Response (DOR) According to RECIST v1.1 in all Randomized Participants;DOR Acccording to RECIST v1.1 in Participants with Detectable PD-L1;Percentage of Participants with Adverse Events (AEs) or Serious AEs (SAEs);Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab;Maximum Serum Concentration (Cmax) for Atezolizumab;Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in all Randomized Participants;TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants with Detectable PD-L1;Minimum Serum Concentration (Cmin) for Atezolizumab;Plasma Concentrations of Total Paclitaxel

Contact information (Source of data: WHO)

Please refer to primary and secondary sponsors

Trial sites

Trial sites in Switzerland (Source of data: BASEC)

Basel, Chur, St Gallen, Zürich

Countries (Source of data: WHO)

Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Italy, Japan, Korea, Latvia, Mexico, Norway, Panama, Poland, Portugal, Republic of, Romania, Russian Federation, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States

Contact for further information on the trial

Details of contact in Switzerland (Source of data: BASEC)

Clinical Trials
+41 61 715 43 91
switzerland.clinical-research@roche.com

Contact for general information (Source of data: WHO)

Clinical Trials
Hoffmann-La Roche

Contact for scientific information (Source of data: WHO)

Clinical Trials
Hoffmann-La Roche

Principal Sponsor/Investigator

Principal sponsor (Source of data: WHO)

Hoffmann-La Roche

Further trial identification numbers

BASEC ID (Source of data: BASEC)

2016-00214

Secondary ID (Source of data: WHO)

2014-005490-37;WO29522