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

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00026845

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Procedure: axillary lymph node dissection Procedure: biopsy Procedure: therapeutic conventional surgery Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mastectomy Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Comparison of overall and disease-free survival [ Designated as safety issue: No ]
Comparison of in-breast only failure [ Designated as safety issue: No ]

Estimated Enrollment:	237
Study Start Date:	September 1979
Estimated Study Completion Date:	February 2006
Estimated Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Active Comparator Patients undergo total mastectomy and axillary dissection.	Procedure: axillary lymph node dissection Patients undergo axillary lymph node dissection Procedure: therapeutic conventional surgery Patients undergo total mastectomy
Arm II: Experimental 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.	Procedure: axillary lymph node dissection Patients undergo axillary lymph node dissection Procedure: biopsy Patients undergo excisional biopsy Radiation: radiation therapy Patients undergo radiation therapy

Detailed 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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00026845

Locations

United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Nicole L. Simone, MD

NCI - Radiation Oncology Branch; ROB

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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 Institute Randomized Trial. Cancer. 2003 Aug 15;98(4):697-702.

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.

Responsible Party:	NCI - Radiation Oncology Branch; ROB ( Nicole L. Simone )
Study ID Numbers:	CDR0000256918, NCI-79-C-0111
Study First Received:	November 14, 2001
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00026845 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 09, 2009