Breast CancerPhase 3IRCISNCT01112254
Evaluation of the Diagnostic Performance of MRI±Biopsy to Optimize Resection of Ductal Carcinoma In Situ (DCIS) Breast Cancer
A Phase 3 study testing MRI±biopsy in people with Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
The purpose of this study is to evaluate the diagnostic performance of MRI±biopsy to optimize resection of Ductal Carcinoma In Situ (DCIS) breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MRI±biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Jun 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T0 or T1 breast DCIS revealed by microcalcifications on mammography + breast ultrasound
- Histological confirmation by percutaneous biopsy : strict DCIS or micro-invasive.
- Radiological focus < 30mm and accessible to conservative treatment.
- Single microcalcification focus
- Age : 18 to 80 years old
- Performance Status < 2
- Patient information and signed informed consent.
Who cannot join
- Invasive carcinoma
- Non biopsiable microcalcification focus under stereotaxy
- Bilateral lesions
- Non feasible MRI (claustrophobic, serious allergy, pace-maker, etc.)
- Refusal of surgery, including mastectomy if necessary
- History of homolateral breast cancer
Show all 10Show fewer
- patient at risk of breast cancer (BRCA1 or 2 mutation or score 5 INSERM table)
- Pregnant or possibly pregnant or breastfeeding woman
- Person deprived of freedom or under guardianship
- Inability to undergo the medical surveillance of the trial for geographical, social or psychological reasons
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the diagnostic performance of MRI±biopsy to optimize resection of Ductal Carcinoma In Situ (DCIS) breast cancer.
Read the detailed description
Ductal carcinoma in situ (DCIS) is a frequent disease, concerning more than 15% of all breast carcinomas in France. Frequency increases due to breast screening programs. Breast conservative treatment can be done for limited lesions. Complete pathological excision with safe surgical margins is the main factor of success rate for conservative treatment. But safe surgical margins are not always obtained in the first surgery because preoperative or peroperative evaluation of the extent of the lesions is difficult. A 20 to 38% rate of involved margins is reported in the literature, implying a second surgery. MRI is not commonly performed today in the preoperative staging of DCIS, despite interesting results of breast MRI in DCIS evaluation published recently in a German study (Kuhl, Lancet 2007). Nevertheless, this retrospective study focused on a population of high-risk women (BRCA1-2 mutation carriers, family history of breast cancer…).
Additional suspicious lesions detected by MRI require MRI-guided or CT-guided biopsy as they are not detectable with mammography or ultrasound. Moreover, intraoperative pathological analysis cannot be performed in DCIS and surgical strategy will be different for a unique lesion (lumpectomy) or multiple/large lesions (mastectomy). If surgery is adapted according to MRI and biopsy results, we can assume that the entire lesion could be removed in a single operation, avoiding re-excisions, anxiety and reducing the costs.
The main objective of this protocol is to evaluate the value of MRI+biopsy in the staging of mammography-detected DCIS in an unselected population of women. It is a multicentric, randomised study including patients from France presenting a unique, limited (< 30 mm) DCIS detected by mammography or breast ultrasound. The two compared arms are: preoperative breast MRI+biopsy versus no additional diagnostic examination. High resolution dynamic 3D images will be obtained in order to detect very small suspicious lesions, typical of DCIS. The main endpoint is the re-excision rate for involved margins. In order to show a reduction of 50% of the rate of second surgery (from 25% to 12.5% in the MRI arm), it is necessary to include 360 patients (bilateral test, alpha=5%, power=80%).
A cost-effective study will be performed. The costs likely to differ between the two arms (MRI, biopsy, outpatient visits, hospitalisations, transportation, and sick leaves) will be assessed using data collected in the trial. The endpoint of the cost-effectiveness study will be the cost by success (cost-effectiveness ratio). A success is defined as achieving margin-negative resection after initial surgery (no need for re-excision). The other secondary endpoints will be to determine the rate of initial mastectomy and to describe MRI morphologic features in the MRI+biopsy arm.
- Conditions
- Breast Cancer
- Being tested
- MRI±biopsy
- Keywords
- Ductal Carcinoma In Situ (DCIS) breast cancer
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI±biopsyProcedure or surgery
A MRI-guided or CT-guided preoperative biopsy will be performed in case of suspicious enhancement, multiple and large lesions (more than 3 cm for from the initial lesion), which is not viewed on the mammography or breast ultrasound. The surgery type will depends on the MRI +/- ± biopsy results.
| Study group | Role | What they receive |
|---|---|---|
| MRI±biopsy | Experimental | a MRI-guided or CT-guided preoperative biopsy will be performed in case of suspicious enhancement, multiple and large lesions (more than 3 cm from the initial lesion), not viewed on the mammography or breast ultrasound. The surgery type will depends on the MRI ± biopsy results. Receives: Procedure: MRI±biopsy |
| Standard care | No intervention | The patients will be operated without additional exams |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-excision rate
After histological confirmation of DCIS by stereotactic biopsy the patients will be randomized. In arm 1, a MRI-guided or CT-guided preoperative biopsy will be performed in case of suspicious enhancement, multiple and large lesions (more than 3 cm from the initial lesion), not viewed on the mammography or breast ultrasound. The surgery type will depends on the MRI ± biopsy results. The patients will be operated without additional exams in arm 2.
Measured: in the 6 months following randomization
Secondary outcomes (2)
Cost-effectiveness study
cost by success, success being defined by the absence of re-excision during the 6-month period after randomization.
Measured: during the 6-month period after randomization
Relapse rate
Measured: at 30 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112254
- Sponsor's protocol ID
- IGR IRCIS 1503
- Acronym
- IRCIS
- Status last verified
- Jan 2016
- First submitted
- 26 Apr 2010
- Last updated
- 26 Jan 2016
- Results posted
- No
Publications
Balleyguier C, Dunant A, Ceugnart L, Kandel M, Chauvet MP, Cherel P, Mazouni C, Henrot P, Rauch P, Chopier J, Zilberman S, Doutriaux-Dumoulin I, Jaffre I, Jalaguier A, Houvenaeghel G, Guerin N, Callonnec F, Chapellier C, Raoust I, Mathieu MC, Rimareix F, Bonastre J, Garbay JR. Preoperative Breast Magnetic Resonance Imaging in Women With Local Ductal Carcinoma in Situ to Optimize Surgical Outcomes: Results From the Randomized Phase III Trial IRCIS. J Clin Oncol. 2019 Apr 10;37(11):885-892. doi: 10.1200/JCO.18.00595. Epub 2019 Feb 27.
PubMed 30811290
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic Performance of MRI±Biopsy to Optimize Resection of Ductal Carcinoma In Situ (DCIS) Breast Cancer
- ClinicalTrials.gov ID
- NCT01112254
- Acronym / sponsor ID
- IRCIS / IGR IRCIS 1503
- Conditions
- Breast Cancer
- Keywords
- Ductal Carcinoma In Situ (DCIS) breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- Feb 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 Apr 2010 (estimated)
- 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.
The purpose of this study is to evaluate the diagnostic performance of MRI±biopsy to optimize resection of Ductal Carcinoma In Situ (DCIS) breast cancer.
Detailed description
Ductal carcinoma in situ (DCIS) is a frequent disease, concerning more than 15% of all breast carcinomas in France. Frequency increases due to breast screening programs. Breast conservative treatment can be done for limited lesions. Complete pathological excision with safe surgical margins is the main factor of success rate for conservative treatment. But safe surgical margins are not always obtained in the first surgery because preoperative or peroperative evaluation of the extent of the lesions is difficult. A 20 to 38% rate of involved margins is reported in the literature, implying a second surgery. MRI is not commonly performed today in the preoperative staging of DCIS, despite interesting results of breast MRI in DCIS evaluation published recently in a German study (Kuhl, Lancet 2007). Nevertheless, this retrospective study focused on a population of high-risk women (BRCA1-2 mutation carriers, family history of breast cancer…).
Additional suspicious lesions detected by MRI require MRI-guided or CT-guided biopsy as they are not detectable with mammography or ultrasound. Moreover, intraoperative pathological analysis cannot be performed in DCIS and surgical strategy will be different for a unique lesion (lumpectomy) or multiple/large lesions (mastectomy). If surgery is adapted according to MRI and biopsy results, we can assume that the entire lesion could be removed in a single operation, avoiding re-excisions, anxiety and reducing the costs.
The main objective of this protocol is to evaluate the value of MRI+biopsy in the staging of mammography-detected DCIS in an unselected population of women. It is a multicentric, randomised study including patients from France presenting a unique, limited (< 30 mm) DCIS detected by mammography or breast ultrasound. The two compared arms are: preoperative breast MRI+biopsy versus no additional diagnostic examination. High resolution dynamic 3D images will be obtained in order to detect very small suspicious lesions, typical of DCIS. The main endpoint is the re-excision rate for involved margins. In order to show a reduction of 50% of the rate of second surgery (from 25% to 12.5% in the MRI arm), it is necessary to include 360 patients (bilateral test, alpha=5%, power=80%).
A cost-effective study will be performed. The costs likely to differ between the two arms (MRI, biopsy, outpatient visits, hospitalisations, transportation, and sick leaves) will be assessed using data collected in the trial. The endpoint of the cost-effectiveness study will be the cost by success (cost-effectiveness ratio). A success is defined as achieving margin-negative resection after initial surgery (no need for re-excision). The other secondary endpoints will be to determine the rate of initial mastectomy and to describe MRI morphologic features in the MRI+biopsy arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI±biopsy | Experimental | Procedure: MRI±biopsya MRI-guided or CT-guided preoperative biopsy will be performed in case of suspicious enhancement, multiple and large lesions (more than 3 cm from the initial lesion), not viewed on the mammography or breast ultrasound. The surgery type will depends on the MRI ± biopsy results. |
| Standard care | No intervention | –The patients will be operated without additional exams |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- T0 or T1 breast DCIS revealed by microcalcifications on mammography + breast ultrasound
- Histological confirmation by percutaneous biopsy : strict DCIS or micro-invasive.
- Radiological focus < 30mm and accessible to conservative treatment.
- Single microcalcification focus
- Age : 18 to 80 years old
Key exclusion criteria (10 listed)
- Invasive carcinoma
- Non biopsiable microcalcification focus under stereotaxy
- Bilateral lesions
- Non feasible MRI (claustrophobic, serious allergy, pace-maker, etc.)
- Refusal of surgery, including mastectomy if necessary
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 |
|---|---|---|
| MRI±biopsyA MRI-guided or CT-guided preoperative biopsy will be performed in case of suspicious enhancement, multiple and large lesions (more than 3 cm for from the initial lesion), which is not viewed on the mammography or breast ultrasound. The surgery type will depends on the MRI +/- ± biopsy results. | Procedure or surgery | MRI±biopsy |
Primary outcome
Re-excision rate
Time frame: in the 6 months following randomization
After histological confirmation of DCIS by stereotactic biopsy the patients will be randomized. In arm 1, a MRI-guided or CT-guided preoperative biopsy will be performed in case of suspicious enhancement, multiple and large lesions (more than 3 cm from the initial lesion), not viewed on the mammography or breast ultrasound. The surgery type will depends on the MRI ± biopsy results. The patients will be operated without additional exams in arm 2.
2 secondary outcomes
Cost-effectiveness study
Time frame: during the 6-month period after randomization
Relapse rate
Time frame: at 30 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
- Derived from this study: PubMed 30811290Balleyguier C, Dunant A, Ceugnart L, Kandel M, Chauvet MP, Cherel P, Mazouni C, Henrot P, Rauch P, Chopier J, Zilberman S, Doutriaux-Dumoulin I, Jaffre I, Jalaguier A, Houvenaeghel G, Guerin N, Callonnec F, Chapellier C, Raoust I, Mathieu MC, Rimareix F, Bonastre J, Garbay JR. Preoperative Breast Magnetic Resonance Imaging in Women With Local Ductal Carcinoma in Situ to Optimize Surgical Outcomes: Results From the Randomized Phase III Trial IRCIS. J Clin Oncol. 2019 Apr 10;37(11):885-892. doi: 10.1200/JCO.18.00595. Epub 2019 Feb 27.
- website of Institut Gustave RoussyLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MRI±biopsy in people with Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site 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 7 inclusion and 10 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: finished, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Re-excision rate (time frame: in the 6 months following randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01112254, which also lists 1 linked publication.
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 26 Jan 2016.