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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

740 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2013-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate surgery

Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen

Group Type ACTIVE_COMPARATOR

Tamoxifen

Intervention Type DRUG

20 mg po daily x 5 years

Surgery: Oophorectomy

Intervention Type 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)

Scheduled surgery

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

Group Type EXPERIMENTAL

Tamoxifen

Intervention Type DRUG

20 mg po daily x 5 years

Surgery: Oophorectomy

Intervention Type 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)

Immediate Surgery - nonrandomized

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

Group Type OTHER

Tamoxifen

Intervention Type DRUG

20 mg po daily x 5 years

Surgery: Oophorectomy

Intervention Type 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)

Interventions

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Tamoxifen

20 mg po daily x 5 years

Intervention Type DRUG

Surgery: Oophorectomy

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)

Intervention Type PROCEDURE

Other Intervention Names

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Nolvadex® ovary removal surgery

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No