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Clinical Trials in the Netherlands / NCT01898117
Active, not recruiting Phase 2

Triple-B Study;Carboplatin-cyclophosphamide Versus Paclitaxel With or Without Atezolizumab as First-line Treatment in Advanced Triple Negative Breast Cancer

NCT01898117 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 2
Started
2013-07
Last updated
2025-11-26

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Carbo/cyclo →Carbo/cyclo + atezolizumab →Paclitaxel →Paclitaxel + AtezolizumabAll Paclitaxel trials (422) →All Atezolizumab trials (175) →

Study summary

Triple negative breast cancer (TNBC) is a difficult to treat molecular subtype with a poor survival. TNBC can be divided into at least two molecular entities; BRCA-like and non-BRCA-like. In this trial we would like to investigate whether a molecular subgroup exists within TNBCs that derives a benefit from atezolizumab added to first line chemotherapy.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Metastasized or locally advanced incurable triple negative breast cancer; patients with stage IV at diagnosis are eligible as well. If the primary lesion is the only measurable lesion according to RECIST criteria, every locoregional treatment must be mentioned to the investigators. * Histologically confirmed triple negative breast cancer (ER: \< 10% nuclear staining of tumor cells on IHC; HER2: either score 0 or 1 at immunohistochemistry or negative at in situ hybridization \[CISH or FISH\] in case of score 2 or 3 on IHC) * Histological confirmation of triple negative breast cancer of a metastatic lesion is recommended * Histological or cytological confirmation of metastatic breast cancer is required in case of normal CA 15.3 levels * Primary tumor or metastasis tissue (10 x10 μm blank slides FFPE tumor material) sent to NKI-AVL for BRCA-like testing * Pretreatment histological biopsy of a metastatic lesion for the translational research questions (tumor tissue from bone metastases cannot be used). * No previous cytotoxic therapy for metastatic disease * Disease-free interval of at least 12 months after completion of adjuvant paclitaxel or platinum compound therapy * Disease-free interval of at least 6 months after completion of adjuvant docetaxel * Measurable disease according to RECIST v1.1 * WHO performance status of 0 or 1 * Adequate bone marrow function: neutrophils ≥ 1.5 x 10E9 cells/l, platelets ≥100 x 10E9 cells/l, Hb ≥ 6.2 mmol/l. * Normal liver function: bilirubin \< 1.5 x upper limit of the normal range (ULN); alkaline phosphatase \< 2.5 x ULN (\< 5 x ULN in case of liver metastases, and \< 7 x ULN in case of bone metastases); transaminases (ASAT/ALAT) \< 2.5 x ULN (and \< 5 x ULN in case of liver metastases). * Normal renal function: \> calculated (Cockcroft-Gault) or measured creatinine clearance \> 50 mL/min * INR \< 1.5 and APTT normal, unless patient is on stable anti-coagulant treatment for at least two weeks with a low molecular weight heparin or coumarin, then an INR within the target range (usually between 2 and 3) is allowed. * Written informed consent Exclusion Criteria: * Receptor conversion to hormone receptor positive (defined as \>= 10% positive ER or PgR tumor cells) or HER2 positive * Another cancer except basal-cell carcinoma of the skin or in situ cervical cancer within the previous 5 years * Other antitumor therapy within the previous 21 days with the exception of endocrine therapy. The patient should have stopped any endocrine therapy before start study treatment. * Radiotherapy with palliative intent within the previous 7 days before randomization. * Known CNS disease except for treated brain metastases. * Uncontrolled serious medical or psychiatric illness * Pre-existing peripheral neuropathy \> grade 1 (NCI-CTC AE (version 4.03)) at inclusion * Severe infection within 4 weeks prior to randomization * received antibiotocs within 2 weeks prior to cycle 1, day 1 * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization or anticipation of need for major surgical procedure during the course of the study * New York Heart Association Class II or greater congestive heart failure. LVEF by MUGA, ultrasound or MRI must be ≥ 50% and should be performed within 4 weeks prior to randomization if cardiac failure is suspected. * History of myocardial infarction or unstable angina within 6 months prior to randomization * History of myocardial infarction or unstable angina or unstable arrhytmias within 3 months prior to randomization futher criteria, see protocol

Primary outcome measure(s)

Trial sites (49)

FacilityCityRegionStatus
MCA Alkmaar Netherlands
Noordwest Ziekenhuis Groep Alkmaar Netherlands
ZGT Almelo Netherlands
Meander Medisch Centrum Amersfoort Netherlands
BovenIJ Amsterdam Netherlands
Netherlands Cancer Institute Amsterdam Netherlands
AZVU Amsterdam Netherlands
OLVG Amsterdam Netherlands
Gelre Ziekenhuis Apeldoorn Netherlands
Rijnstate Arnhem Netherlands
Lievensberg ziekenhuis Bergen op Zoom Netherlands
Rode Kruis Ziekenhuis Beverwijk Netherlands
Amphia Breda Netherlands
IJsselland ziekenhuis Capelle aan den IJssel Netherlands
Reinier de Graaf Gasthuis Delft Netherlands
Deventer ziekenhuis Deventer Netherlands
Albert Schweitzer Ziekenhuis Dordrecht Netherlands
Nijsmellinghe Drachten Netherlands
Ziekenhuis Gelderse Vallei Ede Netherlands
Maxima Medisch Centrum Eindhoven Netherlands
Catharina ziekenhuis Eindhoven Netherlands
Jeroen Bosch ziekenhuis Eindhoven Netherlands
Medisch Spectrum Twente (MST) Enschede Netherlands
Admiraal de Ruyter ziekenhuis Goes Netherlands
Groene Hart Gouda Netherlands
Groene Hart Ziekenhuis Gouda Netherlands
Martini Ziekenhuis Groningen Netherlands
St. Jansdal Harderwijk Netherlands
Tergooi ziekenhuizen Hilversum Netherlands
Spaarne Gasthuis Hoofddorp Netherlands
Dijklander ziekenhuis Hoorn Netherlands
MCL Leeuwarden Netherlands
LUMC Leiden Netherlands
Haaglanden MC Leidschendam Netherlands
MUMC Maastricht Netherlands
St. Antonius ziekenhuis Nieuwegein Netherlands
Bravis ziekenhuis Roosendaal Netherlands
St. Fransicus Gasthuis Rotterdam Netherlands
Ikazia Rotterdam Netherlands
Maasstad Ziekenhuis Rotterdam Netherlands

+ 9 more sites — see the full list on the official registry below.

More The Netherlands Cancer Institute trials in the Netherlands

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01898117 on ClinicalTrials.gov ↗ ← All trials in the Netherlands