Evaluation of the Diagnostic Performance of MRI±Biopsy to Optimize Resection of Ductal Carcinoma In Situ (DCIS) Breast Cancer (IRCIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Gustave Roussy, Cancer Campus, Grand Paris
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT01112254
First received: April 26, 2010
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Procedure: MRI±biopsy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Diagnostic Performance of MRI±Biopsy to Optimize Resection of Ductal Carcinoma In Situ (DCIS) Breast Cancer

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • Re-excision rate [ Time Frame: in the 6 months following randomization ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Cost-effectiveness study [ Time Frame: during the 6-month period after randomization ] [ Designated as safety issue: No ]
    cost by success, success being defined by the absence of re-excision during the 6-month period after randomization.

  • Relapse rate [ Time Frame: at 30 months after randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: February 2010
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRI±biopsy
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.
Procedure: MRI±biopsy
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.
No Intervention: Standard care
The patients will be operated without additional exams

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112254

Contacts
Contact: Corinne BALLEYGUIER, MD 00 33 1 42116074 Corinne.balleyguier@igr.fr
Contact: Jean-Rémi GARBAY, MD 00 33 1 42114350 garbay@igr.fr

Locations
France
Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Principal Investigator: Corinne BALLEYGUIER, MD         
Principal Investigator: Jean-Rémi GARBAY, MD         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
National Cancer Institute, France
  More Information

Additional Information:
No publications provided

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01112254     History of Changes
Other Study ID Numbers: IGR IRCIS 1503
Study First Received: April 26, 2010
Last Updated: June 6, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Ductal Carcinoma In Situ (DCIS) breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Carcinoma, Ductal
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on July 22, 2014