Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Ohio State University Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00201851

Purpose

This trial tests surgical oophorectomy (removal of ovaries) plus Tamoxifen, done at different times in the menstrual cycle, as adjuvant therapy for invasive breast cancer in 510 premenopausal women with Hormone Receptor-positive Breast Cancer. This study is recruiting at hospitals in Philippines, Vietnam, and Morocco.

Condition	Intervention	Phase
Breast Cancer	Drug: Tamoxifen Procedure: Surgery: Oophorectomy	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Tamoxifen Tamoxifen citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Phase III Randomized Study of Immediate Versus Luteal Phase Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

Further study details as provided by Ohio State University Comprehensive Cancer Center:

Estimated Enrollment:	510
Study Start Date:	January 2004

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Open for accrual in Asia only
Female age 18-50,
premenopausal with regular cycles (>25-35 in length)
FNA diagnosis
Stage II-IIIA HR+ invasive breast cancer
No prior radiation or chemotherapy
Must be surgical candidate for bilateral oophorectomy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201851

Locations

Morocco
National Institute of Oncology
Rabat, Morocco
Philippines
Vicente Soto Memorial Medical Center
Cebu, Philippines
Philippine General Hospital
Manila, Philippines
East Avenue Medical Center
Manila, Philippines
Rizal
Manila, Philippines
Santo Toma Hospital
Manila, Philippines
Vietnam
Hospital K, National Cancer Institute
Hanoi, Vietnam
Danang General
Danang, Vietnam
Hue Central
Hue, Vietnam

Sponsors and Collaborators

Ohio State University Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Richard R. Love, M.D.

Ohio State University

More Information

Study ID Numbers:	OSU-0483
Study First Received:	September 12, 2005
Last Updated:	December 26, 2006
ClinicalTrials.gov Identifier:	NCT00201851
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ohio State University Comprehensive Cancer Center:

Asian
Premenopausal
Women
Oophorectomy

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Tamoxifen
Breast Diseases

Additional relevant MeSH terms:

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

Selective Estrogen Receptor Modulators
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009