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

Sponsor:	European Institute of Oncology
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002720

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: tamoxifen citrate Procedure: conventional surgery	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	QUADRANTECTOMY PLUS AXILLARY DISSECTION VERSUS QUADRANTECTOMY ALONE IN MAMMOGRAPHIC STAGE T1N0 BREAST CANCER PATIENTS AGED OVER 65 YEARS

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Surgery

Drug Information available for: Tamoxifen Tamoxifen citrate

U.S. FDA Resources

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

Estimated Enrollment:	642
Study Start Date:	December 1995

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.

Eligibility

Ages Eligible for Study:	65 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002720

Locations

Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milano (Milan), Italy, 20133

Sponsors and Collaborators

European Institute of Oncology

Investigators

Study Chair:

Gabriele Martelli, MD

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000064573, CNR-9502, EU-95020
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00002720 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer

Additional relevant MeSH terms:

Estrogen Antagonists
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Bone Density Conservation Agents

Selective Estrogen Receptor Modulators
Tamoxifen
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009