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Could a pill replace chemo for some breast cancers?

NCT ID NCT03283384

Disease control Sponsor: Borstkanker Onderzoek Groep 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 2 trial tests whether a combination of two drugs, ribociclib and letrozole, can replace standard chemotherapy for postmenopausal women with a common type of breast cancer (hormone receptor positive, HER2 negative). The study involves 100 participants who will receive either the drug combo or chemo before surgery. The goal is to see if the combo stops cancer cell growth as effectively as chemo, potentially offering a gentler treatment option.

What this could mean

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

Active substance
Ribociclib plus letrozole
What this could lead to
If successful, this could offer a less toxic, targeted alternative to chemotherapy for certain breast cancer patients before surgery.
What could go wrong
This is a small, early-phase trial (100 participants) and may not show that the drug combination works as well as chemotherapy. Side effects from ribociclib and letrozole are possible.

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2019

Expected to finish

Aug 2027

An estimate. End dates often move.

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: * Postmenopausal women presenting with histological proven (core biopsy material) hormone receptor positive (ER≥50%, PR any), HER2 negative, stage II/ III breast cancer. * Measurable disease (breast and/or lymph nodes) * WHO 0-2 * Adequate bone marrow function (within 4 weeks prior to registration): WBC≥3.0x109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l * Adequate liver function (within 4 weeks prior to registration): bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL * Adequate renal function (within 4 weeks prior to registration): the calculated creatinine clearance should be ≥50 ml/min * Accessible for treatment and follow-up * Written informed consent Inclusion criteria randomization specific: In order to be eligible to be randomized in this study, a subject must meet all of the following criteria: * Registration in the NEOLBC trial before 2 weeks biopsy * Use of letrozole * Outcome central Ki67 determination in two weeks biopsy available. Exclusion Criteria: * Evidence of distant metastases (M1) * Previous invasive breast cancer * Prior chemotherapy, radiation therapy or hormonal therapy with the exception of patients who received letrozole ≤ 14 days (+ max. 4 days) prior to registration and who are still on letrozole. * Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix. * Peripheral neuropathy \> grade 2, whatever the cause * Serious other diseases as infections (hepatitis B, C and HIV), recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias or on screening, any of the following cardiac parameters: bradycardia (heart rate \<50 at rest) or QTcF ≥450 msec. * Known hypersensitivity reaction to any of the components of the treatment (peanuts, soy) * Currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed. * Currently receiving any of the following substances and cannot be discontinued 7 days prior to randomisation: * Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelo's, star-fruit, pomegranate and Seville oranges. * That have a known risk to prolong the QT interval or induce Torsades de Pointes. * That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5. * Herbal preparations/medications, dietary supplements. * Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.

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Conditions

The condition(s) this trial relates to.

breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Breast neoplasms

Contacts and locations

Locations

  • Academisch Ziekenhuis Maastricht

    Maastricht, Netherlands

  • Amphia Ziekenhuis

    Breda, Netherlands

  • Antonius Ziekenhuis

    Sneek, Netherlands

  • Bravis Ziekenhuis

    Roosendaal, Netherlands

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, Netherlands

  • Catharina Ziekenhuis

    Eindhoven, Netherlands

  • Elisabeth Tweesteden Ziekenhuis

    Tilburg, Netherlands

  • Gelre Ziekenhuizen

    Apeldoorn, Netherlands

  • Groene Hart Ziekenhuis

    Gouda, Netherlands

  • HAGA Ziekenhuis

    The Hague, Netherlands

  • Haaglanden Medisch Centrum

    The Hague, Netherlands

  • Isala

    Zwolle, Netherlands

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, Netherlands

  • Laurentius Ziekenhuis

    Roermond, Netherlands

  • Leiden University Medical Center

    Leiden, Netherlands

  • Maxima Medisch Centrum

    Eindhoven, Netherlands

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek

    Amsterdam, Netherlands

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, Netherlands

  • Spaarne Gasthuis

    Haarlem, Netherlands

  • Stichting Deventer Ziekenhuisgroep

    Deventer, Netherlands

  • Stichting Reinier Haga Groep (Reinier de Graaf Gasthuis)

    Delft, Netherlands

  • Streekziekenhuis Koningin Beatrix

    Winterswijk, Netherlands

  • Tergooi Ziekenhuizen

    Hilversum, Netherlands

  • VieCuri Medisch Centrum

    Venlo, Netherlands

  • Westfriesgasthuis

    Hoorn, Netherlands

  • Ziekenhuis Amstelland

    Amstelveen, Netherlands

  • Ziekenhuis Rivierenland

    Tiel, Netherlands

  • Ziekenhuis St. Jansdal

    Harderwijk, Netherlands

  • Ziekenhuisgroep Twente

    Almelo, Netherlands

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