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

International Breast Cancer Research Foundation

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Procedure: Surgery: Oophorectomy; Drug: Tamoxifen

Study type: Interventional

Funder types: Other

Identifiers

NCT00201851

OSU-0483

Details and patient eligibility

About

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.

Enrollment: 740 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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740 participants in 3 patient groups

Immediate surgery

Active Comparator group

Description:

Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen

Treatment:

Procedure: Surgery: Oophorectomy

Drug: Tamoxifen

Scheduled surgery

Experimental group

Description:

Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen

Treatment:

Procedure: Surgery: Oophorectomy

Drug: Tamoxifen

Immediate Surgery - nonrandomized

Other group

Description:

Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization

Treatment:

Procedure: Surgery: Oophorectomy

Drug: Tamoxifen