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Brief Title: Radiotherapy Omission in Low Risk Ductal in Situ Carcinoma Breast
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
Study ID: NCT03878342
Brief 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.
Detailed Description:
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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
Centre Henri Becquerel, Rouen, , France
Hôpital René Huguenin - Institut Curie, Saint-Cloud, , France
CHU Saint-Etienne, Saint-Étienne, , 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
Name: Alain FOURQUET, MD
Affiliation: Institut Curie
Role: PRINCIPAL_INVESTIGATOR