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Phase 3
18 Years
65 Years
Not Enrolling
Female Breast Neoplasms, Carcinoma, Ductal, Breast

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Trial Information


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

OUTLINE This is a randomized unicenter study. Patients are randomized to 1 o 2 treatment

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

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

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

median follow-up time: 10 years

Safety Issue:


Principal Investigator

Roberto Agresti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan


Italy: Ethics Committee

Study ID:




Start Date:

May 1998

Completion Date:

May 2003

Related Keywords:

  • Female Breast Neoplasms
  • Carcinoma, Ductal, Breast
  • breast cancer
  • axillary dissection
  • Breast Neoplasms
  • Neoplasms
  • Carcinoma
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal