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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roberto Agresti, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier:
NCT01508546
First received: December 15, 2011
Last updated: January 9, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Female Breast Neoplasms
Carcinoma, Ductal, Breast
 Procedure: axillary dissection
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:

Primary Outcome Measures:
  • Difference in breast cancer mortality and overall survival between the two arms [ Time Frame: median follow-up time: 10 years ] [ Designated as safety issue: Yes ]

Enrollment: 565
Study Start Date: May 1998
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: breast surgery with axillary lymphnodes removal Procedure: axillary dissection
Conservative breast surgery with or without axillary dissection
Experimental: Arm 2: breast surgery without axillary lymphnodes removal Procedure: axillary dissection
Conservative breast surgery with or without axillary dissection

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508546

Locations
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
Principal Investigator: Roberto Agresti, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milan
  More Information

No publications provided

Responsible Party: Roberto Agresti, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT01508546     History of Changes
Other Study ID Numbers: 09/98
Study First Received: December 15, 2011
Last Updated: January 9, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
breast cancer
axillary dissection

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Carcinoma
Carcinoma, Ductal, Breast
Carcinoma, Ductal
Neoplasms by Site
 Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on May 16, 2013