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

Carcinoma, Ductal, Breast Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508546
• Other study ID #: 09/98
• Status: Completed
• Phase: Phase 3
• First received: December 15, 2011
• Last updated: January 9, 2012
• Start date: May 1998
• Est. completion date: May 2003

Study information

• Verified date: January 2012
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 565
• Est. completion date: May 2003
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma, Ductal
• Carcinoma, Ductal, Breast
• Female Breast Neoplasms

Intervention

Procedure:
• axillary dissection
Conservative breast surgery with or without axillary dissection

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in breast cancer mortality and overall survival between the two arms		median follow-up time: 10 years	Yes