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QUADRANTECTOMY PLUS AXILLARY DISSECTION VERSUS QUADRANTECTOMY ALONE IN MAMMOGRAPHIC STAGE T1N0 BREAST CANCER PATIENTS AGED OVER 65 YEARS


Phase 3
65 Years
80 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

QUADRANTECTOMY PLUS AXILLARY DISSECTION VERSUS QUADRANTECTOMY ALONE IN MAMMOGRAPHIC STAGE T1N0 BREAST CANCER PATIENTS AGED OVER 65 YEARS


OBJECTIVES:

- Compare the efficacy of quadrantectomy with or without axillary lymph node dissection,
followed by tamoxifen in terms of local and distant relapse rates and overall survival
of patients with stage I, invasive breast cancer.

- Determine the relationship between biological variables, such as hormone receptor
status, cell proliferation, and DNA ploidy, and the clinical outcome of the disease in
these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center.
Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo quadrantectomy with dissection of level I and II axillary lymph
nodes.

- Arm II: Patients undergo quadrantectomy without axillary lymph node dissection.
Patients on both arms receive tamoxifen daily for 5 years.

Patients are followed every 4 months for 2 years, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 642 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven stage I, invasive breast cancer

- Hormone receptor status:

- Estrogen receptor positive

- Progesterone receptor positive or negative

PATIENT CHARACTERISTICS:

Age:

- 65 to 80

Sex:

- Female

Menopausal status:

- Postmenopausal

Performance status:

- Not specified

Life Expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- No serious disease that would preclude surgery

- No other prior or concurrent malignancy except basal cell carcinoma or carcinoma in
situ of the cervix

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Gabriele Martelli, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Authority:

United States: Federal Government

Study ID:

CDR0000064573

NCT ID:

NCT00002720

Start Date:

December 1995

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • Breast Neoplasms

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