NCT00870415

Brief Summary

RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. PURPOSE: This phase II trial is studying different breast-conserving surgery techniques in treating women with breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
263

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Apr 2007

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

March 26, 2009

Last Update Submit

August 16, 2017

Conditions

Breast Cancer

Keywords

stage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancerstage IIIC breast cancerductal breast carcinomainvasive ductal breast carcinoma

Outcome Measures

Primary Outcomes (1)

  • Percentage of histologically healthy margins maintained during resection

    From inclusion to end of intervention

Study Arms (1)

Surgerie

EXPERIMENTAL
Procedure: quality-of-life assessmentProcedure: therapeutic conventional surgery

Interventions

quality-of-life assessmentPROCEDURE
Surgerie
therapeutic conventional surgeryPROCEDURE
Surgerie

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Diagnosis of intraductal breast cancer requiring a wide local resection * Diagnosis of infiltrating ductal breast cancer within range * Diagnosis of invasive breast cancer that has not responded well to neoadjuvant treatment * No multicentric tumor * No gigantomastia * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * No patients subject to a measure of legal protection or unable to express consent * No patients deprived of liberty by judicial or administrative decision or hospitalized without patient consent * Not pregnant or nursing PRIOR CONCURRENT THERAPY: * No prior radiotherapy to the diseased breast * No prior adjuvant treatment * No concurrent participation in another clinical research study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Ductal, Breast

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma, DuctalAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Ductal, Lobular, and Medullary

Study Officials

  • Philippe Rouanet, MD, PhD

    Institut du Cancer de Montpellier - Val d'Aurelle

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 27, 2009

Study Start

April 1, 2007

Primary Completion

April 1, 2009

Study Completion

December 1, 2010

Last Updated

August 21, 2017

Record last verified: 2017-08

Locations

FR(1)