NCT00970983

Brief Summary

The purpose of this study is to evaluate the disease free and overall survival of patients with breast carcinomas of small size, i.e., not greater than 2.0 cm and with clinically non palpable axillary lymph nodes, undergoing either conservative surgery and axillary dissection, or a similar treatment for the primary tumor and rapid analysis of the sentinel lymph node, the result of which determines axillary node dissection or its avoidance is based.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
532

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 1998

Longer than P75 for not_applicable

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

March 1, 1998

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

November 29, 2011

Status Verified

November 1, 2011

Enrollment Period

11.5 years

First QC Date

September 2, 2009

Last Update Submit

November 28, 2011

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

  • disease free survival, overall survival

    every 6 months for the first 5 years and every 8 months afterwards

Secondary Outcomes (1)

  • number of axillary metastases

    every 6 months for the first 5 years and every 8 months afterwards

Study Arms (2)

QUART

ACTIVE COMPARATOR

Patients in this arm will receive quadrantectomy, axillary dissection and radiotherapy (the current standard therapy).

Procedure: quadrantectomy and axillary dissection

QURT (SN-)

EXPERIMENTAL

Patients will receive quadrantectomy, sentinel node investigation and radiotherapy. Selective axillary dissection will be performed if sentinel node is positive.

Procedure: quadrantectomy + sentinel node biopsy

Interventions

quadrantectomy and axillary dissectionPROCEDURE

standard quadrantectomy and axillary dissection

QUART
quadrantectomy + sentinel node biopsyPROCEDURE

standard quadrantectomy and selective axillary dissection only if sentinel node biopsy is positive

QURT (SN-)

Eligibility Criteria

Age40 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 40 and 75 years.
  • Clinical, mammographic or ultrasonographic diagnosis of a unicentric carcinoma with an ultrasonographic diameter of equal or less than 2.0 cm.
  • Axillary lymph nodes that cannot be palpated or that are not clinically suspicious for metastasis.
  • No previously executed therapy (including biopsy) at any outside institution.
  • Those patients with nonpalpable lesions will be subjected to preoperative radioactive occult lesion localization (ROLL) or stereotactic biopsy.
  • Adequate patient information and signature of the informed consent.

You may not qualify if:

  • Lesions diagnosed as non-infiltrating (in-situ) ductal or lobular carcinoma.
  • Paget's disease.
  • Documented multicentricity and/or abundant multifocality of the neoplasm.
  • Clinically metastatic lymph nodes.
  • Patients previously biopsied at other institutions.
  • Carcinomas detected during pregnancy or lactation.
  • Histotypes diverse from breast carcinoma lesions.
  • History of previous malignancy (excluding basocellular carcinoma, in-situ cervical carcinoma and/or contralateral breast carcinoma without recurrence for at least 15 years of follow-up).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology

Milan, Milano, 20141, Italy

Location

Related Publications (1)

  • Veronesi U, Viale G, Paganelli G, Zurrida S, Luini A, Galimberti V, Veronesi P, Intra M, Maisonneuve P, Zucca F, Gatti G, Mazzarol G, De Cicco C, Vezzoli D. Sentinel lymph node biopsy in breast cancer: ten-year results of a randomized controlled study. Ann Surg. 2010 Apr;251(4):595-600. doi: 10.1097/SLA.0b013e3181c0e92a.

    PMID: 20195151DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeLymph Node ExcisionInvestigative Techniques

Study Officials

  • Umberto Veronesi, MD

    European Institute of Oncology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2009

First Posted

September 3, 2009

Study Start

March 1, 1998

Primary Completion

September 1, 2009

Study Completion

April 1, 2010

Last Updated

November 29, 2011

Record last verified: 2011-11

Locations

IT(1)