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

I

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)

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

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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