Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a simple test match the right chemo to each breast cancer patient?

NCT ID NCT01898117

Knowledge-focused Sponsor: The Netherlands Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a genetic test (BRCA1-like) can help doctors choose the best first chemotherapy for people with advanced triple-negative breast cancer. About 304 participants will receive either carboplatin-cyclophosphamide or paclitaxel, with or without the immunotherapy atezolizumab. The goal is to see if the test predicts which treatment works better, and whether adding atezolizumab helps those with high PD-L1 levels.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

304 people

The number who actually took part.

Started

Jul 2013

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced triple negative breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Neoplasm Metastasis triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • AZVU

    Amsterdam, 1081 HV, Netherlands

  • Admiraal de Ruyter ziekenhuis

    Goes, Netherlands

  • Albert Schweitzer Ziekenhuis

    Dordrecht, Netherlands

  • Amphia

    Breda, Netherlands

  • BovenIJ

    Amsterdam, 1034 CS, Netherlands

  • Bravis ziekenhuis

    Roosendaal, Netherlands

  • Catharina ziekenhuis

    Eindhoven, Netherlands

  • Deventer ziekenhuis

    Deventer, 7416 SE, Netherlands

  • Diakonessenziekenhuis

    Utrecht, Netherlands

  • Dijklander ziekenhuis

    Hoorn, Netherlands

  • Elisabeth Tweesteden ziekenhuis

    Tilburg, 5042 AD, Netherlands

  • Gelre Ziekenhuis

    Apeldoorn, Netherlands

  • Groene Hart

    Gouda, 2803 HH, Netherlands

  • Groene Hart Ziekenhuis

    Gouda, Netherlands

  • Haaglanden MC

    Leidschendam, 2262 BA, Netherlands

  • Haga

    The Hague, 2545 CH, Netherlands

  • IJsselland ziekenhuis

    Capelle aan den IJssel, 2906 ZC, Netherlands

  • Ikazia

    Rotterdam, 3083 AN, Netherlands

  • Isala Klinieken

    Zwolle, 8025 AB, Netherlands

  • Jeroen Bosch ziekenhuis

    Eindhoven, Netherlands

  • LUMC

    Leiden, 2333 ZA, Netherlands

  • Lievensberg ziekenhuis

    Bergen op Zoom, 4624 VT, Netherlands

  • MCA

    Alkmaar, 1815 JD, Netherlands

  • MCL

    Leeuwarden, 8934 AD, Netherlands

  • MUMC

    Maastricht, Netherlands

  • Maasstad Ziekenhuis

    Rotterdam, Netherlands

  • Martini Ziekenhuis

    Groningen, Netherlands

  • Maxima Medisch Centrum

    Eindhoven, 5631 BM, Netherlands

  • Meander Medisch Centrum

    Amersfoort, Netherlands

  • Medisch Spectrum Twente (MST)

    Enschede, Netherlands

  • Netherlands Cancer Institute

    Amsterdam, 1066 CX, Netherlands

  • Nijsmellinghe

    Drachten, 9202 NN, Netherlands

  • Noordwest Ziekenhuis Groep

    Alkmaar, Netherlands

  • OLVG

    Amsterdam, Netherlands

  • Reinier de Graaf Gasthuis

    Delft, Netherlands

  • Rijnstate

    Arnhem, Netherlands

  • Rode Kruis Ziekenhuis

    Beverwijk, 1940 EB, Netherlands

  • Spaarne Gasthuis

    Hoofddorp, 2134 TM, Netherlands

  • St. Antonius ziekenhuis

    Nieuwegein, Netherlands

  • St. Fransicus Gasthuis

    Rotterdam, 3045 PM, Netherlands

  • St. Jansdal

    Harderwijk, Netherlands

  • Stichting Franciscus Vlietland Groep locatie Gasthuis

    Rotterdam, Netherlands

  • Tergooi ziekenhuizen

    Hilversum, Netherlands

  • UMCU

    Utrecht, Netherlands

  • VieCuri Medisch Centrum voor Noord-Limburg

    Venlo, Netherlands

  • Vlietland ziekenhuis

    Schiedam, 3118 JH, Netherlands

  • ZGT

    Almelo, 7609 PP, Netherlands

  • Ziekenhuis Gelderse Vallei

    Ede, 6716 RP, Netherlands

  • Zuyderland

    Sittard, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.