NCT01508546

Brief Summary

Rationale Axillary surgery is still fundamental part of breast cancer (BC) management for adjuvant treatment planning. Purpose Randomized phase III trial to compare the effectiveness of surgical therapy with or without axillary dissection following conservative treatment in women with stage I breast cancer. To determine the possibility to avoid axillary surgery in patients with early breast cancer, finding an alternative method to define the need of adjuvant treatment without compromising long-term disease control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
565

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 1998

Longer than P75 for phase_3

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

May 1, 1998

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2011

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
Last Updated

January 12, 2012

Status Verified

January 1, 2012

Enrollment Period

5 years

First QC Date

December 15, 2011

Last Update Submit

January 9, 2012

Conditions

Female Breast NeoplasmsCarcinoma, Ductal, Breast

Keywords

breast canceraxillary dissection

Outcome Measures

Primary Outcomes (1)

  • Difference in breast cancer mortality and overall survival between the two arms

    median follow-up time: 10 years

Study Arms (2)

Arm 1: breast surgery with axillary lymphnodes removal

EXPERIMENTAL
Procedure: axillary dissection

Arm 2: breast surgery without axillary lymphnodes removal

EXPERIMENTAL
Procedure: axillary dissection

Interventions

axillary dissectionPROCEDURE

Conservative breast surgery with or without axillary dissection

Arm 1: breast surgery with axillary lymphnodes removalArm 2: breast surgery without axillary lymphnodes removal

Eligibility Criteria

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

You may qualify if:

  • women with T1N0M0 invasive breast cancer
  • years

You may not qualify if:

  • bilateral breast cancer
  • no other prior or concurrent malignancy except basal cell carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

Related Publications (1)

  • Agresti R, Sandri M, Capri G, Bianchi G, Triulzi T, Lozza L, Trecate G, Trapani A, Ferraris C, Paolini B, Menard S, Greco M, Folli S, Tagliabue E. Axillary surgery versus no-axillary staging in T1N0 breast cancer: 20-year follow-up of the INT 09/98 randomized clinical trial. Br J Surg. 2025 Mar 4;112(3):znae311. doi: 10.1093/bjs/znae311.

    PMID: 40042985DERIVED

MeSH Terms

Conditions

Carcinoma, Ductal, BreastBreast Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, DuctalAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Ductal, Lobular, and MedullaryNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Roberto Agresti, MD

    Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 15, 2011

First Posted

January 12, 2012

Study Start

May 1, 1998

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

January 12, 2012

Record last verified: 2012-01

Locations

IT(1)