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Breast cancer overdiagnosis? landmark trial tests monitoring vs. surgery for Low-Risk DCIS

NCT ID NCT02492607

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing whether women with a very early, low-risk form of breast cancer called DCIS can safely avoid standard treatments like surgery and radiation. Instead, they would simply get a yearly mammogram to monitor the condition. The goal is to see if this 'active surveillance' approach is as good as standard care at preventing invasive breast cancer over 10 years, while sparing women from unnecessary side effects.

What this could mean

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

Active substance
active surveillance (annual mammography)
What this could lead to
If active surveillance works, many women with low-risk DCIS could avoid surgery or radiation without increasing their risk of invasive breast cancer.
What could go wrong
This is a non-randomized trial, so results may be less reliable. There is a chance that delaying treatment could allow some DCIS to progress to invasive cancer.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,500 people

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

Started

Feb 2017

Expected to finish

Feb 2034

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

45 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 * Written informed consent according to ICH GCP, and national andlocal regulations * Women ≥ 45 years old, any menopausal status * Unilateral DCIS grade I or II of any size * American Society of Anesthesiologists (ASA) score 1-2 or 3, only if able to undergo surgery and yearly mammography * Lesions of type 'calcifications only', detected by population-based or opportunistic screening mammography * Within twelve weeks of detection, stereotactic biopsy has to be performed from the area of the calcifications. Preferably vacuum assisted biopsies. Alternatively, at least six 12 G needle biopsies (or the equivalent of six 12 G needles) may be used. ) . Whatever needle size is applied, it is essential to confirm that the biopsies contain representative calcifications via biopsy radiography, microscopy, or both. * Estrogen receptor ≥ 80% positive and HER2 negative: 0 or 1+ or 2+ with negative ISH), analysed centrally by pathology at NKI-AVL * In case of an extended lesion (\> 5 cm): biopsies were taken from the center and the periphery of the lesion, or from two peripheral parts of the lesion * In case of multiple lesions with calcifications biopsies have been taken from two, but not more, groups of calcifications * Marker placement at biopsy site (s) in the breast * FFPE tissue blocks from the biopsy and, if applicable, from the resection specimen, are available for translational research purposes. If no FFPE tissue blocks can be submitted, 10 unstained slides of 4-5 micrometer thickness from the lesion(s) are acceptable * Good correlation between pathological and radiological findings i.e. both findings confirm low-risk DCIS and no suspicion of high- grade DCIS or invasive breast cancer * The interval between histologic diagnosis of low-risk DCIS on biopsy and inclusion is ≤ 12 weeks Exclusion criteria * Estrogen receptor negative: \<80% or HER2 positive: 3+, or 2+ with positive ISH * Presence of either mass, increased focal density or architectural distortion around the calcifications on mammography (suspicious for invasive disease) * Presence of Paget's disease, invasive breast cancer, or pleomorphic LCIS; Lobular neoplasia, referring to atypical lobular hyperplasia (ALH) and/or classic Lobular Carcinoma In Situ according to the WHO Classification of Tumours of the Breast, is no reason to exclude, whereas pleomorphic LCIS is * Symptomatic DCIS e.g. DCIS detected by palpation or bloody nipple discharge * Synchronous invasive carcinoma in the contralateral breast * Prior history of invasive breast cancer or DCIS, prior surgery because of benign breast lesion (s) is allowed * Prior history of other malignancy (except non-melanoma skin cancer and carcinoma in situ of the cervix) unless patient is discharged from follow-up for at least five years. * Serious disease that precludes definitive surgical treatment (e.g cardiovascular/ pulmonary/ renal disease) * Individual with a family member with a known gene mutation associated with increased risk of breast cancer, unless study participant is a proven non-carrier of mutation * Pregnancy or breast-feeding. Contraceptive measures during the trial are mandatory for those patients that will participate in standard treatment arm and adequate counseling should be provided by the treating physician. The duration of contraception will be specified by the treating physician according to patient and treatment characteristics, standard clinical practice and national regulations * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

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Conditions

The condition(s) this trial relates to.

ductal breast carcinoma in situ

As listed by the trial registrant

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

DCIS

Contacts and locations

Locations

  • Academisch Ziekenhuis Maastricht

    Maastricht, Netherlands

  • Albert Schweitzer Ziekenhuis

    Dordrecht, Netherlands

  • Alexander Monro Ziekenhuis

    Bilthoven, Netherlands

  • Alrijne Ziekenhuis

    Leiderdorp, Netherlands

  • Amphia Ziekenhuis

    Breda, Netherlands

  • Antonius Ziekenhuis

    Sneek, Netherlands

  • Bernhoven Ziekenhuis

    Uden, Netherlands

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, Netherlands

  • Catharina Ziekenhuis

    Eindhoven, Netherlands

  • Deventer Ziekenhuis

    Deventer, Netherlands

  • Diakonessenhuis

    Utrecht, Netherlands

  • Dijklander

    Hoorn, Netherlands

  • Dijklander

    Purmerend, Netherlands

  • Erasmus Medisch Centrum

    Rotterdam, Netherlands

  • Flevoziekenhuis

    Almere Stad, Netherlands

  • Franciscus Gasthuis en Vlietland

    Schiedam, Netherlands

  • Gelre ziekenhuizen

    Zutphen, Netherlands

  • Groene Hart Ziekenhuis

    Gouda, Netherlands

  • Haaglanden MC Antoniushove

    Leidschendam, Netherlands

  • Haga ziekenhuis loc Zoetermeer

    Zoetermeer, Netherlands

  • HagaZiekenhuis

    The Hague, Netherlands

  • Isala Klinieken

    Zwolle, Netherlands

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, Netherlands

  • Leids Universitair Medisch Centrum

    Leiden, Netherlands

  • Maasstad Ziekenhuis

    Rotterdam, Netherlands

  • Martini Ziekenhuis

    Groningen, Netherlands

  • Maxima Medisch Centrum

    Eindhoven, Netherlands

  • Maxima Medisch Centrum - Locatie Veldhoven

    Veldhoven, Netherlands

  • Medisch Centrum Leeuwarden

    Leeuwarden, Netherlands

  • Medisch Spectrum Twente Ariensplain

    Enschede, Netherlands

  • Noordwest Ziekenhuisgroep- site Alkmaar

    Alkmaar, Netherlands

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, Netherlands

  • Reinier de Graaf Gasthuis

    Delft, Netherlands

  • Rijnstate Ziekenhuis

    Arnhem, Netherlands

  • Rode Kruis Ziekenhuis

    Beverwijk, Netherlands

  • Saxenburgh Medisch Centrum

    Hardenberg, Netherlands

  • Slingeland Ziekenhuis

    Doetinchem, Netherlands

  • Spaarne Gasthuis

    Haarlem, Netherlands

  • Spaarne ziekenhuis

    Hoofddorp, Netherlands

  • St Jans Gasthuis

    Weert, Netherlands

  • St. Antonius Ziekenhuis

    Nieuwegein, Netherlands

  • St. Elisabeth Ziekenhuis

    Tilburg, Netherlands

  • Streekziekenhuis Koningin Beatrix

    Winterswijk, Netherlands

  • Ter Gooi

    Hilversum, Netherlands

  • The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

    Amsterdam, Netherlands

  • Tjongerschans Ziekenhuis

    Heerenveen, Netherlands

  • Treant Zorggroep Bethesda

    Hoogeveen, Netherlands

  • Universitair Medisch Centrum Groningen

    Groningen, Netherlands

  • Universitair Medisch Centrum Utrecht

    Utrecht, Netherlands

  • VieCuri - Medisch Centrum voor Noord-Limburg - Locatie Venlo

    Venlo, Netherlands

  • Wilhelmina Ziekenhuis Assen

    Assen, Netherlands

  • Zaans Medisch Centrum

    Zaandam, Netherlands

  • Ziekenhuis Gelderse Vallei

    Ede, Netherlands

  • Ziekenhuis Rivierenland

    Tiel, Netherlands

  • Ziekenhuis St. Jansdal

    Harderwijk, Netherlands

  • Ziekenhuisgroep Twente

    Hengelo, Netherlands

  • Zorgsaam Zeeuws-Vlaanderen

    Terneuzen, Netherlands

  • Zorgsaam Ziekenhuis

    Terneuzen, Netherlands

  • Zuyderland Medisch Centrum

    Heerlen, Netherlands

  • Zuyderland Ziekenhuis

    Sittard, Netherlands

More trials for these conditions

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