Intraductal Carcinoma and Lobular Carcinoma in SituCINNAMOMENCT01841749
Management of Ductal Carcinoma in Situ or Pure Micro-invasive Extended Breast
An observational study of Intraductal Carcinoma and Lobular Carcinoma in Situ, run by Institut Bergonié at 1 site in France.
Trial summary
When invasive components are discovered at mastectomy for vacuum-assisted biopsy (VAB)-diagnosed ductal carcinoma in situ (DCIS), the only option available is axillary lymph node dissection (ALND). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intraductal Carcinoma and Lobular Carcinoma in Situ
- What is being tested?
- sentinel node biopsy and mastectomy
- Type of treatment
- Surgery or procedure
- How many people
- 228 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Dec 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients were recruited from 14 participating French comprehensive cancer centers.
Who may be able to join
- Older than 18 years.
- Preoperative histological diagnosis obtained by biopsy
- Ductal carcinoma in situ (DCIS) or pure micro-invasive (DCIS-MI)
- Indication of mastectomy
- Patient signed informed consent
Who cannot join
- Age < 18 years
- Infiltrating ductal carcinoma (TCC) diagnosed on biopsy
- Pure DCIS diagnosed by lumpectomy
- DCIS can take a conservative treatment
- Mastectomy chosen by the patient
- History of breast carcinoma in situ or invasive ipsilateral
Show all 10Show fewer
- Prior radiotherapy to the ipsilateral breast
- History of axillary lateral homo
- Patient who for reasons psychological, social, family or geographical could not be treated or monitored regularly according to the criteria of the study
- Patient deprived of liberty or under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Ductal Carcinoma in Situ (DCIS) or Pure Micro-invasive (DCIS-MI) Extended Breast, Axillary Node Sentinel Site (GAS) When the Diagnosis is Made by Biopsy and Treatment by Mastectomy Immediately. Descriptive Study
When invasive components are discovered at mastectomy for vacuum-assisted biopsy (VAB)-diagnosed ductal carcinoma in situ (DCIS), the only option available is axillary lymph node dissection (ALND). The aim of this prospective multicenter trial was to determine the benefit of performing upfront sentinel lymph node (SLN) biopsy for these patients.
- Being tested
- sentinel node biopsy and mastectomy
- Keywords
- Breast cancer
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sentinel node biopsy and mastectomyProcedure or surgery
sentinel node biopsy and mastectomy
| Study group | Role | What they receive |
|---|---|---|
| Surgery | sentinel node biopsy and mastectomy Receives: Procedure: sentinel node biopsy and mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Women Who Benefited of Performing Upfront Sentinel Lymph Node (SLN) Biopsy Ductal Carcinoma in Situ
Women who benefited of performing upfront sentinel lymph node (SLN) biopsy are women for whom unecessary axillary lymph node dissection (ALND) was avoided.
The proportion of women who benefited of performing upfront sentinel lymph node (SLN) biopsy is calculated as :
- numerator : number of patients with negative SLNs
- denominator : total number of patients with mastectomy-diagnosed DCIS with microinvasion (mDCIS-MI) or mastectomy-diagnosed DCIS with associated invasive carcinoma (mDCIS-IDC).
Measured: at surgery
Secondary outcomes (1)
Discordance Rate Between Vacuum-assisted Biopsy (VAB) and Mastectomy
Numerator : number of patients with discordant results between VAB and mastectomy Denominator : total number of patients
Measured: at surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startJan 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraductal Carcinoma and Lobular Carcinoma in SituStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TUNON DE LARA Christine, MD, Study chair, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841749
- Sponsor's protocol ID
- IB2007-40
- Acronym
- CINNAMOME
- Status last verified
- Sep 2025
- First submitted
- 5 Nov 2012
- Last updated
- 12 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Tunon-de-Lara C, Chauvet MP, Baranzelli MC, Baron M, Piquenot J, Le-Bouedec G, Penault-Llorca F, Garbay JR, Blanchot J, Mollard J, Maisongrosse V, Mathoulin-Pelissier S, MacGrogan G. The Role of Sentinel Lymph Node Biopsy and Factors Associated with Invasion in Extensive DCIS of the Breast Treated by Mastectomy: The Cinnamome Prospective Multicenter Study. Ann Surg Oncol. 2015 Nov;22(12):3853-60. doi: 10.1245/s10434-015-4476-5. Epub 2015 Mar 17.
PubMed 25777085
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Ductal Carcinoma in Situ (DCIS) or Pure Micro-invasive (DCIS-MI) Extended Breast, Axillary Node Sentinel Site (GAS) When the Diagnosis is Made by Biopsy and Treatment by Mastectomy Immediately. Descriptive Study
- ClinicalTrials.gov ID
- NCT01841749
- Acronym / sponsor ID
- CINNAMOME / IB2007-40
- Keywords
- Breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Posted 12 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When invasive components are discovered at mastectomy for vacuum-assisted biopsy (VAB)-diagnosed ductal carcinoma in situ (DCIS), the only option available is axillary lymph node dissection (ALND). The aim of this prospective multicenter trial was to determine the benefit of performing upfront sentinel lymph node (SLN) biopsy for these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | – | Procedure: sentinel node biopsy and mastectomysentinel node biopsy and mastectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were recruited from 14 participating French comprehensive cancer centers.
Key inclusion criteria (5 listed)
- Older than 18 years.
- Preoperative histological diagnosis obtained by biopsy
- Ductal carcinoma in situ (DCIS) or pure micro-invasive (DCIS-MI)
- Indication of mastectomy
- Patient signed informed consent
Key exclusion criteria (10 listed)
- Age < 18 years
- Infiltrating ductal carcinoma (TCC) diagnosed on biopsy
- Pure DCIS diagnosed by lumpectomy
- DCIS can take a conservative treatment
- Mastectomy chosen by the patient
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 |
|---|---|---|
| sentinel node biopsy and mastectomysentinel node biopsy and mastectomy | Procedure or surgery | Surgery |
Primary outcome
Proportion of Women Who Benefited of Performing Upfront Sentinel Lymph Node (SLN) Biopsy Ductal Carcinoma in Situ
Time frame: at surgery
Women who benefited of performing upfront sentinel lymph node (SLN) biopsy are women for whom unecessary axillary lymph node dissection (ALND) was avoided. The proportion of women who benefited of performing upfront sentinel lymph node (SLN) biopsy is calculated as : * numerator : number of patients with negative SLNs * denominator : total number of patients with mastectomy-diagnosed DCIS with microinvasion (mDCIS-MI) or mastectomy-diagnosed DCIS with associated invasive carcinoma (mDCIS-IDC).
1 secondary outcome
Discordance Rate Between Vacuum-assisted Biopsy (VAB) and Mastectomy
Time frame: at surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25777085Tunon-de-Lara C, Chauvet MP, Baranzelli MC, Baron M, Piquenot J, Le-Bouedec G, Penault-Llorca F, Garbay JR, Blanchot J, Mollard J, Maisongrosse V, Mathoulin-Pelissier S, MacGrogan G. The Role of Sentinel Lymph Node Biopsy and Factors Associated with Invasion in Extensive DCIS of the Breast Treated by Mastectomy: The Cinnamome Prospective Multicenter Study. Ann Surg Oncol. 2015 Nov;22(12):3853-60. doi: 10.1245/s10434-015-4476-5. Epub 2015 Mar 17.
- Individual participant dataSharing planned: No
Related trials for Intraductal Carcinoma and Lobular Carcinoma in Situ
RecruitingObservational study
Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study
Mastectomy, Breast Neoplasm Malignant Primary
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Not yet recruiting
Addressing Financial Hardship in AYA Cancer Survivors Through the Use of the New LIFT UP Intervention
Breast Ductal Carcinoma In Situ, Hematopoietic and Lymphatic System Neoplasm
RecruitingPhase 2
DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
Ductal Carcinoma in Situ
Active, not recruitingPhase 3
Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma
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.
TUNON DE LARA Christine, MD study chair
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraductal Carcinoma and Lobular Carcinoma in Situ, run by Institut Bergonié 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 5 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 12 Sep 2025. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Women Who Benefited of Performing Upfront Sentinel Lymph Node (SLN) Biopsy Ductal Carcinoma in Situ (time frame: at surgery). 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 NCT01841749, 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 12 Sep 2025.