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Conservative Surgery With or Without Axillary Lymphnode Removal in Treating Women With T1N0 Breast Cancer

Primary Purpose

Female Breast Neoplasms, Carcinoma, Ductal, Breast

Status

Completed

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

axillary dissection

About this trial

This is an interventional treatment trial for Female Breast Neoplasms focused on measuring breast cancer, axillary dissection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

women with T1N0M0 invasive breast cancer
18-65 years

Exclusion Criteria:

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

Sites / Locations

Fondazione IRCCS Istituto Nazionale dei Tumori

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm 1: breast surgery with axillary lymphnodes removal

Arm 2: breast surgery without axillary lymphnodes removal

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01508546

First Posted

December 15, 2011

Last Updated

January 9, 2012

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

1. Study Identification

Unique Protocol Identification Number

NCT01508546

Brief Title

Conservative Surgery With or Without Axillary Lymphnode Removal in Treating Women With T1N0 Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

May 1998 (undefined)

Primary Completion Date

May 2003 (Actual)

Study Completion Date

May 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

OBJECTIVES: To compare the efficacy of conservative surgery, with or without axillary lymphnode removal (quadrantectomy with axillary dissection (QUAD) vs. quadrantectomy alone (QU)) followed by adjuvant treatment. To plan no adjuvant therapy vs. adjuvant therapy (eA+CMF+TAM regimen) based on a biological panel of the primary tumor in the QU group (defined as good panel (GP) ( ER+, and up to one unfavourable features (G3, Her2+++, Laminin Receptor+) or bad panel (BP)(ER-, or ER+ and more than one unfavourable features), whereas in QUAD group based on good factor ( N-, ER+ and GI-II disease (GF)) or bad factor ( N+ or GIII or ER- disease (BF)). To determine the relationship between the biological variables (hormone receptor status, grading, Laminin receptor, and c-erbB2) and the clinical outcome of the disease in these patients. OUTLINE This is a randomized unicenter study. Patients are randomized to 1 o 2 treatment arms. Arm 1: patients undergo conservative surgery with axillary lymphnodes removal Arm 2: patients undergo conservative surgery without axillary lymphnodes removal Post-operative adjuvant strategy was previously described. Patients are followed every 4 months for the first two years, every 6 months for the following two years, and then annually thereafter. PROJECT ACCRUAL 600 patients will be accrued for this study over 4 years ELIGIBILITY Ages eligible for study: 18-65 years Genders eligible for study: female

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Female Breast Neoplasms, Carcinoma, Ductal, Breast

Keywords

breast cancer, axillary dissection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

565 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: breast surgery with axillary lymphnodes removal

Arm Type

Experimental

Arm Title

Arm 2: breast surgery without axillary lymphnodes removal

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

axillary dissection

Intervention Description

Conservative breast surgery with or without axillary dissection

Primary Outcome Measure Information:

Title

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

Time Frame

median follow-up time: 10 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: women with T1N0M0 invasive breast cancer 18-65 years Exclusion Criteria: bilateral breast cancer no other prior or concurrent malignancy except basal cell carcinoma

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roberto Agresti, MD

Organizational Affiliation

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fondazione IRCCS Istituto Nazionale dei Tumori

City

Milan

ZIP/Postal Code

20133

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

Conservative Surgery With or Without Axillary Lymphnode Removal in Treating Women With T1N0 Breast Cancer

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