Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I Breast Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

February 6, 2009

Start Date ^ICMJE

December 1995

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002720 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I Breast Cancer

Official Title ^ICMJE

QUADRANTECTOMY PLUS AXILLARY DISSECTION VERSUS QUADRANTECTOMY ALONE IN MAMMOGRAPHIC STAGE T1N0 BREAST CANCER PATIENTS AGED OVER 65 YEARS

Brief Summary

RATIONALE: Surgery to remove axillary lymph nodes may be an effective treatment for women with breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of therapy with or without axillary lymph node dissection following quadrantectomy in treating older women with stage I breast cancer that is estrogen receptor positive.

Detailed Description

OBJECTIVES:

Compare the efficacy of quadrantectomy with or without axillary lymph node dissection, followed by tamoxifen in terms of local and distant relapse rates and overall survival of patients with stage I, invasive breast cancer.
Determine the relationship between biological variables, such as hormone receptor status, cell proliferation, and DNA ploidy, and the clinical outcome of the disease in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo quadrantectomy with dissection of level I and II axillary lymph nodes.
Arm II: Patients undergo quadrantectomy without axillary lymph node dissection. Patients on both arms receive tamoxifen daily for 5 years.

Patients are followed every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 642 patients will be accrued for this study within 3 years.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Active Control

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: tamoxifen citrate
Procedure: conventional surgery

Study Arms / Comparison Groups

Publications *

* 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

642

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Histologically proven stage I, invasive breast cancer
Hormone receptor status:
- Estrogen receptor positive
- Progesterone receptor positive or negative

PATIENT CHARACTERISTICS:

Age:

65 to 80

Sex:

Female

Menopausal status:

Postmenopausal

Performance status:

Not specified

Life Expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

No serious disease that would preclude surgery
No other prior or concurrent malignancy except basal cell carcinoma or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Not specified

Gender

Female

Ages

65 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT ID ^ICMJE

NCT00002720

Responsible Party

Study ID Numbers ^ICMJE

CDR0000064573, CNR-9502, EU-95020

Study Sponsor ^ICMJE

European Institute of Oncology

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Gabriele Martelli, MD

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Information Provided By

National Cancer Institute (NCI)

Verification Date

August 2000

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