DCISROMANCENCT03878342
Radiotherapy Omission in Low Risk Ductal in Situ Carcinoma Breast
A study testing Radiotherapy and No Radiotherapy in people with DCIS and Breast Cancer, run by UNICANCER at 37 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- DCIS, Breast Cancer, Low Risk DCIS
- What is being tested?
- Radiotherapy and No Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 37 sitesFrance
- Study dates
- 10 May 2019to 14 Nov 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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,
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
France37 sites
Institut de Cancérologie de l'Ouest -Site Paul Papin
Angers
Institut Sainte Catherine
Avignon
Centre d'Oncologie et de Radiothérapie du Pays Basque
Bayonne
Clinique Belharra
Bayonne
Institut Bergonie
Bordeaux
Centre Francois Baclesse
Caen
Centre Hospitalier du Cotentin
Cherbourg
Centre Jean Perrin
Clermont-Ferrand
CHIC Créteil
Créteil
Hôpital Henri Mondor
Créteil
Centre Georges Francois Leclerc
Dijon
Centre Hospitalier De Lagny Sur Marne
Jossigny
CHU Saint-Pierre La Réunion
La Réunion
Centre Guillaume le Conquérant
Le Havre
Centre Oscar Lambret
Lille
Chu De Limoges - Hopital Dupuytren
Limoges
Centre Hospitalier Bretagne Sud
Lorient
Centre de Radiothérapie Mermoz
Lyon
Centre Léon Berard
Lyon
Hôpital La Croix Rousse
Lyon
Institut Regional Du Cancer Montpellier Val D Aurelle
Montpellier
Centre Azuréen De Cancérologie
Mougins
Centre Antoine Lacassagne
Nice
Centre de Haute Energie
Nice
Hopital Pitie Salpetriere
Paris
Institut CURIE
Paris
Centre Hospitalier Lyon Sud
Pierre-Bénite
Institut Jean Godinot
Reims
Centre Eugène Marquis
Rennes
Centre Frédéric Joliot
Rouen
Hôpital René Huguenin - Institut Curie
Saint-Cloud
CHU Saint-Etienne
Saint-Etienne
Centre De Radiothérapie De La Robertsau
Strasbourg
Centre Paul Strauss
Strasbourg
Institut Claudius Regaud
Toulouse
Institut De Cancerologie De Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy
Gustave Roussy
Villejuif
About this study
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
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.
Read more
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.
- Being tested
- Radiotherapy, No Radiotherapy
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
two fractionation regimens will be allowed for whole-breast irradiation: 50 Gy in 25 fractions over 5 weeks or 40 Gy in 15 fractions over 3 weeks. The delivery of an additional dose to the tumour bed (boost) will be at the referring physician discretion, according to the guidelines
No RadiotherapyOther
No Irradiation- Active surveillance
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Active comparator | two fractionation regimens will be allowed for whole-breast irradiation: 50 Gy in 25 fractions over 5 weeks or 40 Gy in 15 fractions over 3 weeks. The delivery of an additional dose to the tumour bed (boost) will be at the referring physician discretion, according to the guidelines Receives: Radiation: Radiotherapy |
| No Radiotherapy | Experimental | No Irradiation- Active surveillance Receives: Other: No Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year cumulative incidence of in-breast cancer recurrences
Incidence of breast recurrence is determined from the date of last surgery to the date of breast recurrence.
Measured: 5 years
Secondary outcomes (9)
Overall survival (OS)
OS is defined as the interval between the date of last surgery and the date of death from any cause;
Measured: 10 years
Breast cancer-specific survival (BCSS)
BCSS is defined as the interval between the date of last surgery and the date of death from breast cancer
Measured: 10 years
Relapse-free survival (RFS)
RFS is defined as the interval between the date of last surgery and the date of ipsilateral breast recurrence, regional nodes recurrence, distant metastases, of death from breast cancer, whichever occurs first
Measured: 10 years
Rate of in-breast recurrences (IBR).
In-breast recurrence defined as any carcinoma (invasive or in situ) occurring in the treated breast
Measured: 10 years
Rate of Contralateral breast
Contralateral breast cancer defined as any carcinoma (invasive or in situ) occurring in the contralateral breast.
Measured: 10 years
Quality of life of the patients using EORTC-QLQ-C 30
Quality of life will be assessed using QLQ-C 30 questionnaire from the European Organization for Research and Treatment of Cancer (EORTC). It is a 30-item self-reporting questionnaire developed to assess the quality of life of cancer patients. It is grouped into five functional subscales (role, physical, cognitive, emotional and social functioning). In addition, there are three multi-item symptom scales (fatigue, pain, and nausea and vomiting), individual questions concerning common symptoms in cancer patients,and two questions assessing overall Quality of Life
Measured: 3 years
Quality of life of the patients using EORTC-QLQ-BR23
Quality of Life of Patients will be assessed using a EORTC-QLQ BR23.It is a 23-item self-reporting specific questionnaire developed to assess the quality of life of breast cancer patients. It permits to evaluate the symptoms of breast cancer and the side effects of treatment.
Measured: 3 years
Cosmetics Evaluation
cosmetic results will be evaluated by centralized photographic analysis.
Measured: 3 years
Long term toxicities
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders and so the late effects and sequelea regarding the whole-breast radiotherapy.
Measured: Throughout study completion, up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start10 May 2019
- Primary completion14 Nov 2029 (estimated)
- Study completion14 Nov 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DCISStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Alain FOURQUET, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878342
- Sponsor's protocol ID
- UC-0107/1803
- Acronym
- ROMANCE
- Status last verified
- Jan 2026
- First submitted
- 14 Mar 2019
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03878342
- Acronym / sponsor ID
- ROMANCE / UC-0107/1803
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 295 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- 10 May 2019 (actual)
- Primary completion
- 14 Nov 2029 (estimated)
- Study completion
- 14 Nov 2034 (estimated)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Active comparator | Radiation: Radiotherapytwo fractionation regimens will be allowed for whole-breast irradiation: 50 Gy in 25 fractions over 5 weeks or 40 Gy in 15 fractions over 3 weeks. The delivery of an additional dose to the tumour bed (boost) will be at the referring physician discretion, according to the guidelines |
| No Radiotherapy | Experimental | Other: No RadiotherapyNo Irradiation- Active surveillance |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiotherapytwo fractionation regimens will be allowed for whole-breast irradiation: 50 Gy in 25 fractions over 5 weeks or 40 Gy in 15 fractions over 3 weeks. The delivery of an additional dose to the tumour bed (boost) will be at the referring physician discretion, according to the guidelines | Radiation | Radiotherapy |
| No RadiotherapyNo Irradiation- Active surveillance | Other | No Radiotherapy |
Primary outcome
5-year cumulative incidence of in-breast cancer recurrences
Time frame: 5 years
Incidence of breast recurrence is determined from the date of last surgery to the date of breast recurrence.
9 secondary outcomes
Overall survival (OS)
Time frame: 10 years
Breast cancer-specific survival (BCSS)
Time frame: 10 years
Relapse-free survival (RFS)
Time frame: 10 years
Rate of in-breast recurrences (IBR).
Time frame: 10 years
Rate of Contralateral breast
Time frame: 10 years
Quality of life of the patients using EORTC-QLQ-C 30
Time frame: 3 years
Quality of life of the patients using EORTC-QLQ-BR23
Time frame: 3 years
Cosmetics Evaluation
Time frame: 3 years
Long term toxicities
Time frame: Throughout study completion, up to 10 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain FOURQUET, MD principal investigator
Institut Curie
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy and No Radiotherapy in people with DCIS and Breast Cancer, run by UNICANCER at 37 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year cumulative incidence of in-breast cancer recurrences (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.