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 (ROMANCE)
Interventional
N/A
UNICANCER (Voir sur ClinicalTrials)
mai 2019
novembre 2034
28 novembre 2024
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) | ||||
| MSP DE LAGNY SUR MARNE | 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 Haute Energie - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre Eugène Marquis - Rennes - France | Contact (sur clinicalTrials) | ||||
| Centre Francois Baclesse - Caen - France | Contact (sur clinicalTrials) | ||||
| Centre Frédéric Joliot - Rouen - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Bretagne Sud - Lorient - France | Contact (sur clinicalTrials) | ||||
| Centre Jean Perrin - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - Lille - France | Contact (sur clinicalTrials) | ||||
| Chu De Limoges - Hopital Dupuytren - Limoges - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut De Cancerologie De Lorraine Alexis Vautrin - Vandœuvre-lès-Nancy - France | Contact (sur clinicalTrials) | ||||
| Institut Jean Godinot - Reims - France | Contact (sur clinicalTrials) | ||||
| Institut Regional Du Cancer Montpellier Val D Aurelle - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Institut Sainte Catherine - Avignon - 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 - France | Contact (sur clinicalTrials) | ||||
| Centre Azuréen De Cancérologie - Mougins - France | Contact (sur clinicalTrials) | ||||
| Centre De Radiothérapie De La Robertsau - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Centre de Radiothérapie Mermoz - Lyon - France | Contact (sur clinicalTrials) | ||||
| Centre d'Oncologie et de Radiothérapie du Pays Basque - Bayonne - France | Contact (sur clinicalTrials) | ||||
| Centre Guillaume le Conquérant - Le Havre - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier du Cotentin - Cherbourg - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Lyon Sud - Pierre-Bénite - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Berard - Lyon - France | Contact (sur clinicalTrials) | ||||
| Centre Paul Strauss - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| CHIC Créteil - Créteil - France | Contact (sur clinicalTrials) | ||||
| CHU Saint-Etienne - Saint-Étienne - France | Contact (sur clinicalTrials) | ||||
| CHU Saint-Pierre La Réunion - La Réunion - France | Contact (sur clinicalTrials) | ||||
| Clinique Belharra - Bayonne - France | Contact (sur clinicalTrials) | ||||
| Hôpital Henri Mondor - Créteil - France | Contact (sur clinicalTrials) | ||||
| Hôpital La Croix Rousse - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hôpital René Huguenin - Institut Curie - Saint-Cloud - France | Contact (sur clinicalTrials) | ||||
| Institut Claudius Regaud - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de l'Ouest -Site Paul Papin - Angers - France | Contact (sur clinicalTrials) | ||||
Critères
Femme
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.
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.
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,