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

Tracking Information

First Received Date ^ICMJE

November 14, 2001

Last Updated Date

April 9, 2009

Start Date ^ICMJE

September 1979

Estimated Primary Completion Date

February 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00026845 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Active Control

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Procedure: axillary lymph node dissection
Procedure: biopsy
Procedure: therapeutic conventional surgery
Radiation: radiation therapy

Study Arms / Comparison Groups

Active Comparator: Patients undergo total mastectomy and axillary dissection.
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.

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

237

Completion Date

February 2006

Estimated Primary Completion Date

February 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00026845

Responsible Party

Nicole L. Simone, NCI - Radiation Oncology Branch; ROB

Study ID Numbers ^ICMJE

CDR0000256918, NCI-79-C-0111

Study Sponsor ^ICMJE

National Cancer Institute (NCI)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Nicole L. Simone, MD

NCI - Radiation Oncology Branch; ROB

Information Provided By

National Cancer Institute (NCI)

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP