Status:
ACTIVE_NOT_RECRUITING
Radiotherapy Omission in Low Risk Ductal in Situ Carcinoma Breast
Lead Sponsor:
UNICANCER
Collaborating Sponsors:
The French National Cancer Institute
Conditions:
DCIS
Breast Cancer
Eligibility:
FEMALE
50+ years
Phase:
NA
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 re...
Eligibility Criteria
Inclusion
- Woman aged ≥50 years,
- ECOG performance status ≤2
- Microcalcifications on pre-biopsy mammography, unifocal, ≤25 mm or opacity without microcalcifications and no clinical palpable tumour
- 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;
- Breast-conserving surgical excision;
- 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.
- Free margins (≥2 mm), or free margins following re-excision;
- 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.
- 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.
- Absence of extensive necrosis (≤30% of the lumen diameter);
- 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%.
- 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;
- Written informed consent.
- Affiliation to the French social security.
Exclusion
- Endocrine treatment for breast cancer.
- Previous invasive breast cancer including contralateral breast cancer, either metachronous or synchronous
- Previous DCIS except contralateral DCIS in complete and continuous remission for more than 5 years
- 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
- Known breast-cancer predisposing germ-cell mutation;
- Palpable tumour with a diagnosis of DCIS on biopsy
- Bloody nipple discharge;
- Histological size \>25 mm in one or multiple foci
- High nuclear grade, including high nuclear grade in heterogeneous tumours;either on biopsy or on surgical specimen
- Associated microinvasive or invasive component;
- Presence of tumour cells in lymph nodes detected using H\&E or immunohistochemical examination (if lymph node sentinel biopsy or dissection has been performed);
- Absolute contra-indication to whole-breast irradiation as determined by the referring physician;
- 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.
- Pregnant women or breast feeding mothers,
Key Trial Info
Start Date :
May 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2034
Estimated Enrollment :
295 Patients enrolled
Trial Details
Trial ID
NCT03878342
Start Date
May 10 2019
End Date
November 14 2034
Last Update
November 27 2024
Active Locations (37)
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1
Institut de Cancérologie de l'Ouest -Site Paul Papin
Angers, France
2
Institut Sainte Catherine
Avignon, France
3
Centre d'Oncologie et de Radiothérapie du Pays Basque
Bayonne, France
4
Clinique Belharra
Bayonne, France