NCT03878342: ROMANCE

Radiotherapy Omission in Low Risk Ductal in Situ Carcinoma Breast

Active, enrolled NA Last updated 23 January 2026

What this trial tests

NA trial testing Radiotherapy in DCIS in 295 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 May 2019

Primary endpoint
14 November 2029

14 November 2034

Quick facts

Lead sponsor	UNICANCER
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	295
Start date	10 May 2019
Primary completion	14 November 2029
Estimated completion	14 November 2034
Sites	37 locations across France

Drugs / interventions tested

• Radiotherapy — full drug profile →
• No Radiotherapy

Conditions studied

• DCIS — all drugs for DCIS →
• Breast Cancer — all drugs for Breast Cancer →
• Low Risk DCIS — all drugs for Low Risk DCIS →
• Breast Conserving Surgery — all drugs for Breast Conserving Surgery →

Sponsor

UNICANCER — full company profile →

Who can join

50 and older, female only, with DCIS or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tools to Guide Radiation Oncologists in the Management of DCIS.
   Leonardi MC, Zerella MA, Lazzeroni M, Fusco N, et al · · 2024 · cited 1× · PMID 38610216 · DOI 10.3390/healthcare12070795
2. On the Frontiers of Breast Cancer Diagnosis and Treatment: Current and Future Directions in a Rapidly Changing Field.
   Efird JT, Jindal C, Biswas T. · · 2022 · PMID 36013493 · DOI 10.3390/medicina58081026