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Can a new chemo schedule extend life with fewer side effects?

NCT ID NCT01746225

Disease control Sponsor: ETOP IBCSG Partners Foundation 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests three different schedules of the chemotherapy drug nab-paclitaxel (Abraxane) in women with HER2-negative metastatic breast cancer. The goal is to find a schedule that allows patients to stay on treatment longer, potentially improving progression-free survival, while reducing the side effects that come with continuous chemotherapy. Each schedule is compared against a historical reference to see if it deserves further study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nab-paclitaxel (Abraxane), a chemotherapy drug
What this could lead to
If one of the schedules works well, it could offer a more tolerable way to prolong chemotherapy for metastatic breast cancer, potentially improving how long patients live without the disease progressing.
What could go wrong
This is a phase II trial, so results are preliminary. The drug may still cause side effects, and the benefit over standard treatment is not guaranteed.

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

258 people

The number who actually took part.

Start date

Apr 2013

Finished

Mar 2023

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

18 years and older

Sex

Female participants only

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: * Histologically or cytologically confirmed HER2-negative metastatic (stage IV) breast cancer. * Measurable or non-measurable, but radiologically evaluable, disease according to RECIST 1.1 criteria. * Female aged 18 years or older. * Life expectancy \> 3 months. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Either ER-positive or ER-negative disease. Patients with ER-positive disease must be endocrine resistant, defined as having failed at least one prior endocrine therapy for breast cancer, or must be candidates for first-line chemotherapy. * If previously treated with a taxane or anthracycline in the neoadjuvant or adjuvant setting, the period from end of treatment to disease recurrence must have been \> 12 months (\> 365 days). * Radiation therapy, if given and regardless of site, must be completed at least 2 weeks prior to randomization. * Normal hematologic status. * Normal renal function. * Normal liver function. * Normal cardiac function. * Women of childbearing potential: documented negative pregnancy test within 2 weeks prior to randomization, and acceptable birth control during the duration of the trial therapy and for a period of 6 months following the last administration of study drug. * Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization. * Completed baseline Quality of Life Form. * The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines. * Availability of an formalin fixed paraffin embedded (FFPE) block from the primary tumor (breast lesion) for submission to central pathology review and for translational research. * Written consent to pathology material submission, signed and dated by the patient and the Investigator prior to randomization. Exclusion Criteria: * Any prior chemotherapy for metastatic breast cancer. * Presence of central nervous system (CNS) metastasis. * Peripheral neuropathy grade 2 or higher (CTCAE version 4). * Significant uncontrolled cardiac disease (i.e. unstable angina, recent myocardial infarction within prior 6 months), patients classified as having a New York Heart Association (NYHA) class III or IV congestive heart failure. * Pregnant or lactating. * Prior history of non-breast malignancy (except for adequately controlled basal cell carcinoma of the skin, carcinoma in situ of the cervix, in situ carcinoma of the bladder). * Any concurrent condition which in the Investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol. * Contraindications or known hypersensitivity to the study medication or excipients. * The use of any anti-cancer investigational agents within 30 days prior to expected start of trial treatment. * Inability or unwillingness to abide by the study protocol or cooperate fully with the Investigator.

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Conditions

The condition(s) this trial relates to.

breast cancer Her2-receptor negative breast cancer neoplasm Neoplasm Metastasis

As listed by the trial registrant

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

Metastatic breastcancer

Contacts and locations

Locations

  • Azienda Osp. Universitaria di Udine

    Udine, 33100, Italy

  • Azienda Ospedaliera SS Antonio e Biagio

    Alessandria, 15121, Italy

  • Beaumont Hospital

    Dublin, Ireland

  • Bon Secours

    Cork, Ireland

  • CHR de la Citadelle, Oncology-Haematology Unit

    Liège, 4000, Belgium

  • CHU Sart Tilman, Medical Oncology

    Liège, 4000, Belgium

  • Centre Hospitalier Peltzer-La Tourelle, Department of Clinical Cancerology

    Verviers, 4800, Belgium

  • Consorcop Hospitalario Provincial De Castellon

    Castelló, 12002, Spain

  • Cork University Hospital

    Cork, Ireland

  • E.O. Ospedali Galliera

    Genova, 16128, Italy

  • Fondazione Salvatore Maugeri

    Pavia, 27100, Italy

  • Hospital Universitari Arnau De Vilanova De Lleida

    Lleida, 25198, Spain

  • Hospital Universitari Sant Joan De Reus

    Tarragona, 43204, Spain

  • Hospital Universitari Vall D'Hebron

    Barcelona, Spain

  • Hospital Universitario Lozano Blesa De Zaragoza

    Zaragoza, 50009, Spain

  • IRCCS MultiMedica

    Castellanza, 21053, Italy

  • Institute of Oncology

    Ljubljana, 1000, Slovenia

  • Instituto Oncologico della Svizzera Italiana

    Bellinzona, 6500, Switzerland

  • Istituto Europeo di Oncologia (IEO)

    Milan, Italy

  • Kantonsspital Aarau

    Aarau, 5001, Switzerland

  • Kantonsspital Baselland

    Liestal, 4410, Switzerland

  • Kantonsspital Graubünden

    Chur, 7000, Switzerland

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007, Switzerland

  • Kantonsspital Winterthur

    Winterthur, 8401, Switzerland

  • Luzerner Kantonsspital

    Lucerne, 6000, Switzerland

  • Mater Misericordiae University Hospital

    Dublin, Ireland

  • Mater Private Hospital

    Dublin, Ireland

  • Mid-Western Regional Hospital

    Limerick, Ireland

  • Onkologiezentrum Thun-Berner Oberland

    Thun, 3600, Switzerland

  • Ospedale degli Infermi

    Biella, 13900, Italy

  • Ospedale di Circolo e Fondatione Macchi

    Varese, 21100, Italy

  • Spitalzentrum Biel

    Biel, 2501, Switzerland

  • St James's Hospital

    Dublin, Ireland

  • St Vincent's University Hospital

    Dublin, Ireland

  • U.O. Oncologia, AUSL Rimini

    Rimini, 47923, Italy

  • Universita degli Studi di Roma La Sapienza

    Roma, 00161, Italy

  • University Hospital Galway

    Galway, Ireland

  • Universitätsspital Basel

    Basel, 4031, Switzerland

  • Universitätsspital/ Inselspital Bern

    Bern, 3011, Switzerland

  • Uo Medicina Ocologica Ospedale Di Carpri e Mirandola, Azienda USL di Modena

    Modena, 41012, Italy

  • Waterford Regional Hospital

    Waterford, Ireland

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