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

December 15, 2011
January 9, 2012
May 1998
May 2003   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01508546 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Conservative Surgery With or Without Axillary Lymphnode Removal in Treating Women With T1N0 Breast Cancer
Not Provided

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Female Breast Neoplasms
  • Carcinoma, Ductal, Breast
Procedure: axillary dissection
Conservative breast surgery with or without axillary dissection
  • Experimental: Arm 1: breast surgery with axillary lymphnodes removal
    Intervention: Procedure: axillary dissection
  • Experimental: Arm 2: breast surgery without axillary lymphnodes removal
    Intervention: Procedure: axillary dissection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
565
May 2003
May 2003   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01508546
09/98
No
Roberto Agresti, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Not Provided
Principal Investigator: Roberto Agresti, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milan
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP