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Managing low-risk DCIS with active surveillance

Management of Low Risk Ductal Carcinoma in Situ (Low-risk DCIS): a Non-randomized, Multicenter, Non-inferiority Trial; Standard Therapy Approach Versus Active Surveillance

NA · The Netherlands Cancer Institute · NCT02492607

This study is testing if women with low-risk ductal carcinoma in situ (DCIS) can safely skip aggressive treatments and just be monitored to see how it affects their health over time.

Quick facts

PhaseNA
Study typeInterventional
Enrollment2500 (estimated)
Ages45 Years and up
SexFemale
SponsorThe Netherlands Cancer Institute (other)
Locations60 sites (Alkmaar and 59 other locations)
Trial IDNCT02492607 on ClinicalTrials.gov

What this trial studies

This study investigates whether women with low-risk ductal carcinoma in situ (DCIS) can safely avoid intensive treatments through an active surveillance approach. It is a non-randomized, international, multicenter trial that compares the outcomes of active surveillance against conventional treatments such as wide local excision, radiotherapy, or mastectomy. The primary goal is to assess the rate of invasive breast tumors over a 10-year period, while secondary endpoints include overall survival and patient-reported outcomes. The study aims to reduce unnecessary treatments and improve the quality of life for patients diagnosed with low-risk DCIS.

Who should consider this trial

Good fit: Ideal candidates are women aged 45 and older with unilateral low-risk DCIS (grade I or II) detected through screening.

Not a fit: Patients with high-risk DCIS or those requiring immediate treatment due to aggressive disease characteristics may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the number of women undergoing unnecessary invasive treatments for low-risk DCIS.

How similar studies have performed: Other studies have suggested that active surveillance may be a viable option for low-risk DCIS, indicating potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Alkmaar and 59 other locations

+10 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: DCIS, Women, DCIS grade I and II, Active surveillance, Standard treatment

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.