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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: NCI - Center for Cancer Research-Medical Oncology
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: radiation therapy
Procedure: therapeutic conventional surgery
Phase III

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Mastectomy   

U.S. FDA Resources

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

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
Procedure: 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
NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)

Investigators
Study Chair:     Nicole L. Simone, MD     NCI - Radiation Oncology Branch; ROB    
  More Information


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

Publications of Results:
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.
 

Study ID Numbers:   CDR0000256918, NCI-79-C-0111
First Received:   November 14, 2001
Last Updated:   December 2, 2008
ClinicalTrials.gov Identifier:   NCT00026845
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer  
stage II breast cancer  

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on December 03, 2008




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