NCT01112254

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

5.3 years

First QC Date

April 26, 2010

Last Update Submit

January 25, 2016

Conditions

Breast Cancer

Keywords

Ductal Carcinoma In Situ (DCIS) breast cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    in the 6 months following randomization

Secondary Outcomes (2)

  • Cost-effectiveness study

    during the 6-month period after randomization

  • Relapse rate

    at 30 months after randomization

Study Arms (2)

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.

Procedure: MRI±biopsy

Standard care

NO INTERVENTION

The patients will be operated without additional exams

Interventions

MRI±biopsyPROCEDURE

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.

MRI±biopsy

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94800, France

Location

Related Publications (1)

  • 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.

    PMID: 30811290DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2010

First Posted

April 28, 2010

Study Start

February 1, 2010

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

FR(1)