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Radiation-Free path for Low-Risk breast cancer patients?

NCT ID NCT03878342

Disease control Sponsor: UNICANCER 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 women aged 50 and older with a very low-risk type of early breast cancer (called DCIS) can avoid radiation therapy after having breast-conserving surgery. The goal is to see if the cancer stays away without radiation, reducing unnecessary treatment and side effects. About 295 participants are being followed for 5 years to check for any return of cancer in the breast.

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

295 people

The number who actually took part.

Started

May 2019

Expected to finish

Nov 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

50 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: 1. Woman aged ≥50 years, 2. ECOG performance status ≤2 3. Microcalcifications on pre-biopsy mammography, unifocal, ≤25 mm or opacity without microcalcifications and no clinical palpable tumour 4. Absence of suspicious residual microcalcifications either on post-biopsy/ preoperative localization mammography, or on post-operative mammography Note: if absence of residual microcalcifications on post-biopsy/pre-operative mammography, post-operative mammography is not mandatory; 5. Breast-conserving surgical excision; 6. Histologically proven DCIS of the breast without an invasive component; Note Incidental histological finding of DCIS lesions developed within a benign breast lesion as well as an association with classical lobular carcinoma in situ (LCIS) associated with the DCIS are accepted. 7. Free margins (≥2 mm), or free margins following re-excision; 8. Low or Intermediate nuclear grade; Note: In case of nuclear grade heterogeneity within the same sample or between the biopsy or the surgical specimen, the highest nuclear grade score will prevail. 9. Tumour tissue sample availability; Note: Surgical specimen is mandatory unless no residual disease on the surgical specimen. In this instance, the initial diagnosis biopsy is required. 10. Absence of extensive necrosis (≤30% of the lumen diameter); 11. Immunohistochemical characteristics of luminal A subtype: ER≥10 %, PR ≥20 %, HER2 negative (0/1+) or 2+ not amplified (confirmed by fluorescent in situ hybridization (FISH) or chromogenic in situ hybridization (CISH)), Ki67 \<15%. 12. Patient willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits and examinations and including follow-up; 13. Written informed consent. 14. Affiliation to the French social security. Exclusion Criteria: 1. Endocrine treatment for breast cancer. 2. Previous invasive breast cancer including contralateral breast cancer, either metachronous or synchronous 3. Previous DCIS except contralateral DCIS in complete and continuous remission for more than 5 years 4. Previous other cancers (except basal-cell, carcinoma in situ of the cervix or endometrium), not in complete and continuous remission for more than 10 years 5. Known breast-cancer predisposing germ-cell mutation; 6. Palpable tumour with a diagnosis of DCIS on biopsy 7. Bloody nipple discharge; 8. Histological size \>25 mm in one or multiple foci 9. High nuclear grade, including high nuclear grade in heterogeneous tumours;either on biopsy or on surgical specimen 10. Associated microinvasive or invasive component; 11. Presence of tumour cells in lymph nodes detected using H\&E or immunohistochemical examination (if lymph node sentinel biopsy or dissection has been performed); 12. Absolute contra-indication to whole-breast irradiation as determined by the referring physician; 13. Patient unable to comply with study obligations for geographic, social, or physical reasons, or who is unable to understand the purpose and procedures of the study. 14. Pregnant women or breast feeding mothers,

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm ductal breast carcinoma in situ

As listed by the trial registrant

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

Breast cancer Breast conserving surgery DCIS Low risk dcis Radiotherapy omission

Contacts and locations

Locations

  • CHIC Créteil

    Créteil, France

  • CHU Saint-Etienne

    Saint-Etienne, France

  • CHU Saint-Pierre La Réunion

    La Réunion, France

  • Centre Antoine Lacassagne

    Nice, France

  • Centre Azuréen De Cancérologie

    Mougins, France

  • Centre De Radiothérapie De La Robertsau

    Strasbourg, France

  • Centre Eugène Marquis

    Rennes, France

  • Centre Francois Baclesse

    Caen, France

  • Centre Frédéric Joliot

    Rouen, France

  • Centre Georges Francois Leclerc

    Dijon, France

  • Centre Guillaume le Conquérant

    Le Havre, France

  • Centre Hospitalier Bretagne Sud

    Lorient, France

  • Centre Hospitalier De Lagny Sur Marne

    Jossigny, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, France

  • Centre Hospitalier du Cotentin

    Cherbourg, France

  • Centre Jean Perrin

    Clermont-Ferrand, France

  • Centre Léon Berard

    Lyon, France

  • Centre Oscar Lambret

    Lille, France

  • Centre Paul Strauss

    Strasbourg, France

  • Centre d'Oncologie et de Radiothérapie du Pays Basque

    Bayonne, France

  • Centre de Haute Energie

    Nice, France

  • Centre de Radiothérapie Mermoz

    Lyon, France

  • Chu De Limoges - Hopital Dupuytren

    Limoges, France

  • Clinique Belharra

    Bayonne, France

  • Gustave Roussy

    Villejuif, France

  • Hopital Pitie Salpetriere

    Paris, France

  • Hôpital Henri Mondor

    Créteil, France

  • Hôpital La Croix Rousse

    Lyon, France

  • Hôpital René Huguenin - Institut Curie

    Saint-Cloud, France

  • Institut Bergonie

    Bordeaux, France

  • Institut CURIE

    Paris, France

  • Institut Claudius Regaud

    Toulouse, France

  • Institut De Cancerologie De Lorraine Alexis Vautrin

    Vandœuvre-lès-Nancy, France

  • Institut Jean Godinot

    Reims, France

  • Institut Regional Du Cancer Montpellier Val D Aurelle

    Montpellier, France

  • Institut Sainte Catherine

    Avignon, France

  • Institut de Cancérologie de l'Ouest -Site Paul Papin

    Angers, France

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