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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.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00026845
First received: November 14, 2001
Last updated: September 29, 2011
Last verified: September 2011
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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:

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

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
Arms Assigned Interventions
Active Comparator: Arm I
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
Experimental: 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.
 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:
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.

Responsible Party: Nicole L. Simone, NCI - Radiation Oncology Branch; ROB
ClinicalTrials.gov Identifier: NCT00026845     History of Changes
Other Study ID Numbers: 790111, CDR0000256918, NCI-79-C-0111
Study First Received: November 14, 2001
Last Updated: September 29, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 22, 2013