Comparison of Surgeries, With or Without Radiation Therapy, in Treating Women With Stage I or Stage II Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00026845
• Other study ID #: 790111, CDR0000256918
• Secondary ID: NCI-79-C-0111
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 14, 2001
• Last updated: September 29, 2011
• Start date: September 1979

Study information

• Verified date: September 2011
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: It is not yet known which combination of surgeries is more effective in reducing side effects and improving recovery in treating breast cancer.

PURPOSE: This randomized phase III trial is comparing how well axillary lymph node dissection with either mastectomy or excisional biopsy plus radiation therapy works in treating women with stage I or stage II breast cancer.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 237
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• axillary lymph node dissection
Patients undergo axillary lymph node dissection
• biopsy
Patients undergo excisional biopsy
• therapeutic conventional surgery
Patients undergo total mastectomy

Radiation:
• radiation therapy
Patients undergo radiation therapy

Locations

Country	Name	City	State
United States	National Cancer Institute (NCI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Dan TD, Ly D, Hewitt SM, et al.: Prognostic value of CD44s in the NCI randomized trial on breast conservation with 25-year follow-up. [Abstract] J Clin Oncol 28 (Suppl 15): A-634, 2010.

Poggi MM, Danforth DN, Sciuto LC, et al.: Cancer events after 18 years of follow-up in the treatment of early-stage breast cancer with mastectomy versus breast conservation therapy. [Abstract] Breast Cancer Res Treat 76 (Suppl 1): A-28, 2002.

Poggi MM, Danforth DN, Sciuto LC, Smith SL, Steinberg SM, Liewehr DJ, Menard C, Lippman ME, Lichter AS, Altemus RM. Eighteen-year results in the treatment of early breast carcinoma with mastectomy versus breast conservation therapy: the National Cancer In — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of overall and disease-free survival			No
Primary	Comparison of in-breast only failure			No