Radiotherapy Omission in Low Risk Ductal in Situ Carcinoma Breast
Condition(s) studied
Investigational drug(s) / intervention(s)
Radiotherapy: two fractionation regimens will be allowed for whole-breast irradiation: 50 Gy in 25 fractions over 5 weeks or 40 Gy in 15 fractions over 3 weeks. The delivery of an additional dose to the tumour bed (boost) will be at the referring physician discretion, according to the guidelines
No Radiotherapy: No Irradiation- Active surveillance
Study summary
Following breast-conserving surgery (BCS) for localized ductal carcinoma in situ (DCIS) of the breast, whole-breast irradiation (WBRT) is a standard of care, reducing the absolute rate of in-breast recurrences (IBR) by more than 15% at 10 years, from 28% without radiotherapy to 13 % with radiotherapy. Half of the recurrences occurred as invasive disease. Whereas in the comparative trials, WBRT did not impact on overall survival, survival of patients who recurred with invasive cancers was impaired in comparison to patients who did not recur, or to patients with DCIS-only recurrences.
Using criteria based on age, tumor size, nuclear grade, and margins status, several trials and cohort studies failed to identify subgroups of patients at low risk, who could be safely spared the need for WBRT. The Radiation Therapy Oncology Group (RTOG) DCIS trial included patients treated with BCS for low- or intermediate grade DCIS revealed by unifocal microcalcifications, size ≤25 mm, margins ≥3 mm, and no residual microcalcifications after surgery. The 5-year rates of IBR were 3.5 % without radiotherapy, versus 0.4 % with radiotherapy, and 6.7 % and 0.9 % at 7 years, respectively (p \<0.001). Sixty percent of the patients received tamoxifen in both groups.
Several studies showed that the same molecular classes were identified in DCIS as in invasive cancers. Studies suggested that low proliferation, hormone receptors expression, and lack of ERBB2 amplification were associated with a low risk of IBR in patients not receiving radiotherapy. A combined signature was tested in the Eastern Cooperative Oncology Group (ECOG) trial, showing a 10% IBR rate at ten years in patients with a low-risk.
Identifying very low-risk DCIS, using biological markers in addition to the clinical and histological markers of low-risk DCIS, could help to select patients who could be safely avoided WBRT following BCS. It would avoid over-treatment in these women and could decrease the cost of management.
Eligibility
Primary outcome measure(s)
- 5-year cumulative incidence of in-breast cancer recurrences — 5 years
Incidence of breast recurrence is determined from the date of last surgery to the date of breast recurrence.
Trial sites (37)
| Facility | City | Region | Status |
|---|---|---|---|
| Institut de Cancérologie de l'Ouest -Site Paul Papin | Angers | France | |
| Institut Sainte Catherine | Avignon | France | |
| Centre d'Oncologie et de Radiothérapie du Pays Basque | Bayonne | France | |
| Clinique Belharra | Bayonne | France | |
| Institut Bergonie | Bordeaux | France | |
| Centre Francois Baclesse | Caen | France | |
| Centre Hospitalier du Cotentin | Cherbourg | France | |
| Centre Jean Perrin | Clermont-Ferrand | France | |
| CHIC Créteil | Créteil | France | |
| Hôpital Henri Mondor | Créteil | France | |
| Centre Georges Francois Leclerc | Dijon | France | |
| Centre Hospitalier De Lagny Sur Marne | Jossigny | France | |
| CHU Saint-Pierre La Réunion | La Réunion | France | |
| Centre Guillaume le Conquérant | Le Havre | France | |
| Centre Oscar Lambret | Lille | France | |
| Chu De Limoges - Hopital Dupuytren | Limoges | France | |
| Centre Hospitalier Bretagne Sud | Lorient | France | |
| Centre de Radiothérapie Mermoz | Lyon | France | |
| Centre Léon Berard | Lyon | France | |
| Hôpital La Croix Rousse | Lyon | France | |
| Institut Regional Du Cancer Montpellier Val D Aurelle | Montpellier | France | |
| Centre Azuréen De Cancérologie | Mougins | France | |
| Centre Antoine Lacassagne | Nice | France | |
| Centre de Haute Energie | Nice | France | |
| Hopital Pitie Salpetriere | Paris | France | |
| Institut CURIE | Paris | France | |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | France | |
| Institut Jean Godinot | Reims | France | |
| Centre Eugène Marquis | Rennes | France | |
| Centre Frédéric Joliot | Rouen | France | |
| Hôpital René Huguenin - Institut Curie | Saint-Cloud | France | |
| CHU Saint-Etienne | Saint-Etienne | France | |
| Centre De Radiothérapie De La Robertsau | Strasbourg | France | |
| Centre Paul Strauss | Strasbourg | France | |
| Institut Claudius Regaud | Toulouse | France | |
| Institut De Cancerologie De Lorraine Alexis Vautrin | Vandœuvre-lès-Nancy | France | |
| Gustave Roussy | Villejuif | France |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03878342 on ClinicalTrials.gov ↗ ← All trials in France