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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

National Institute of Oncology, Rabat, Morocco

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Tamoxifen

Drug

20 mg po daily x 5 years

Other names: Nolvadex®

Surgery: Oophorectomy

Procedure

Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)

Other names: ovary removal surgery

Primary outcomes

Disease-free Survival

Time frame: two- to three-year accrual and initial two or more years of follow-up period

5-year disease-free survival

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Completed

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Sponsors and collaborators

Lead sponsor

International Breast Cancer Research Foundation

Other

Registry information

Official study title

Phase III Randomized Study of Immediate Versus Luteal Phase Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-positive Breast Cancer

Important dates

Study start: 2004
Primary completion: 2011
Study completion: 2013
First posted: Sep 20, 2005
Registry last updated: Apr 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed