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Radiotherapy Omission in Low Risk Ductal in Situ Carcinoma Breast
Sponsor: UNICANCER
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.
Official title: Prospective Study of Omission of Whole-breast Radiotherapy Following Breast-conserving Surgery in Patients With Very Low Risk Ductal Carcinoma in Situ of the Breast
Key Details
Gender
FEMALE
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
295
Start Date
2019-05-10
Completion Date
2034-11-14
Last Updated
2026-01-23
Healthy Volunteers
No
Interventions
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
Locations (37)
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