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The Treatment Of Clinical Stage I And II Carcinoma Of The Breast With Mastectomy And Axillary Dissection Versus Excisional Biopsy, Axillary Dissection And Definitive Irradiation


Phase 3
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

The Treatment Of Clinical Stage I And II Carcinoma Of The Breast With Mastectomy And Axillary Dissection Versus Excisional Biopsy, Axillary Dissection And Definitive Irradiation


OBJECTIVES:

- Compare the overall and disease-free survival of women with stage I or II breast cancer
treated with mastectomy and axillary dissection vs excisional biopsy, axillary
dissection, and definitive radiotherapy.

- Compare in-breast only failure in patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo total mastectomy and axillary dissection.

- Arm II: Patients undergo excisional biopsy and axillary dissection followed by whole
breast radiotherapy and a boost to the tumor bed. Patients with positive axillary
dissections undergo radiotherapy to the supraclavicular nodes.

In both arms, patients with positive nodes receive cyclophosphamide and doxorubicin.

Patients are followed for at least 20 years.

PROJECTED ACCRUAL: A total of 237 patients (116 for arm I and 121 for arm II) were accrued
for this study within 8 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed invasive breast cancer

- Stage I or II (T1-2, N0-1, M0)

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- Not specified

Sex

- Female

Menopausal status

- Not specified

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Comparison of overall and disease-free survival

Safety Issue:

No

Principal Investigator

Nicole L. Simone, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Radiation Oncology Branch; ROB

Authority:

United States: Federal Government

Study ID:

790111, CDR0000256918

NCT ID:

NCT00026845

Start Date:

September 1979

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • Breast Neoplasms

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892