Informations générales (source: ClinicalTrials.gov)
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
Interventional
N/A
UNICANCER (Voir sur ClinicalTrials)
mai 2019
novembre 2034
02 février 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:18 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Sofia RIVERA | 11/04/2024 10:52:10 | Contacter | ||
| CLCC RENE HUGUENIN INSTITUT CURIE | 10/04/2025 13:12:01 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | Contact (sur clinicalTrials) | ||||
| CENTRE NEPHROCARE MARNE LA VALLEE | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre De Radiothérapie De La Robertsau - Strasbourg 2973783 - France | Contact (sur clinicalTrials) | ||||
| Centre Eugène Marquis - Rennes 2983990 - France | Contact (sur clinicalTrials) | ||||
| Centre Frédéric Joliot - Rouen 2982652 - France | Contact (sur clinicalTrials) | ||||
| Centre Guillaume le Conquérant - Le Havre 3003796 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Bretagne Sud - Lorient 2997577 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier du Cotentin - Cherbourg 3025466 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Lyon Sud - Pierre-Bénite 2987314 - France | Contact (sur clinicalTrials) | ||||
| Centre Jean Perrin - Clermont-Ferrand 3024635 - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Berard - Lyon 2996944 - France | Contact (sur clinicalTrials) | ||||
| Centre Paul Strauss - Strasbourg 2973783 - France | Contact (sur clinicalTrials) | ||||
| Institut Claudius Regaud - Toulouse 2972315 - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de l'Ouest -Site Paul Papin - Angers 3037656 - France | Contact (sur clinicalTrials) | ||||
| Institut Sainte Catherine - Avignon 3035681 - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - Nice 2990440 - France | Contact (sur clinicalTrials) | ||||
| Centre Azuréen De Cancérologie - Mougins 2991551 - France | Contact (sur clinicalTrials) | ||||
| Centre de Haute Energie - Nice 2990440 - France | Contact (sur clinicalTrials) | ||||
| Centre de Radiothérapie Mermoz - Lyon 2996944 - France | Contact (sur clinicalTrials) | ||||
| Centre d'Oncologie et de Radiothérapie du Pays Basque - Bayonne 3034475 - France | Contact (sur clinicalTrials) | ||||
| Centre Francois Baclesse - Caen 3029241 - France | Contact (sur clinicalTrials) | ||||
| Centre Georges Francois Leclerc - Dijon 3021372 - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - Lille 2998324 - France | Contact (sur clinicalTrials) | ||||
| CHIC Créteil - Créteil 3022530 - France | Contact (sur clinicalTrials) | ||||
| Chu De Limoges - Hopital Dupuytren - Limoges 2998286 - France | Contact (sur clinicalTrials) | ||||
| CHU Saint-Etienne - Saint-Etienne 2980291 - France | Contact (sur clinicalTrials) | ||||
| CHU Saint-Pierre La Réunion - La Réunion 6619528 - France | Contact (sur clinicalTrials) | ||||
| Clinique Belharra - Bayonne 3034475 - France | Contact (sur clinicalTrials) | ||||
| Gustave Roussy - Villejuif 2968705 - France | Contact (sur clinicalTrials) | ||||
| Hôpital Henri Mondor - Créteil 3022530 - France | Contact (sur clinicalTrials) | ||||
| Hôpital La Croix Rousse - Lyon 2996944 - France | Contact (sur clinicalTrials) | ||||
| Hôpital René Huguenin - Institut Curie - Saint-Cloud 2981041 - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - Bordeaux 3031582 - France | Contact (sur clinicalTrials) | ||||
| Institut CURIE - Paris 2988507 - France | Contact (sur clinicalTrials) | ||||
| Institut De Cancerologie De Lorraine Alexis Vautrin - Vandœuvre-lès-Nancy 2970797 - France | Contact (sur clinicalTrials) | ||||
| Institut Jean Godinot - Reims 2984114 - France | Contact (sur clinicalTrials) | ||||
| Institut Regional Du Cancer Montpellier Val D Aurelle - Montpellier 2992166 - France | Contact (sur clinicalTrials) | ||||
Critères
Femme
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,