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

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ClinicalTrials.gov Identifier: NCT00201851
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : April 29, 2015
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
International Breast Cancer Research Foundation

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Tamoxifen Procedure: Surgery: Oophorectomy Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 740 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Immediate Versus Luteal Phase Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-positive Breast Cancer
Study Start Date : January 2004
Actual Primary Completion Date : December 2011
Actual Study Completion Date : May 2013

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U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Immediate surgery
Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen
Drug: Tamoxifen
20 mg po daily x 5 years
Other Name: Nolvadex®
Procedure: 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)
Other Name: ovary removal surgery
Experimental: Scheduled surgery
Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen
Drug: Tamoxifen
20 mg po daily x 5 years
Other Name: Nolvadex®
Procedure: 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)
Other Name: ovary removal surgery
Immediate Surgery - nonrandomized
Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization
Drug: Tamoxifen
20 mg po daily x 5 years
Other Name: Nolvadex®
Procedure: 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)
Other Name: ovary removal surgery



Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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)
  • 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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00201851


Locations
Morocco
National Institute of Oncology
Rabat, Morocco
Philippines
Vicente Soto Memorial Medical Center
Cebu, Philippines
East Avenue Medical Center
Manila, Philippines
Philippine General Hospital
Manila, Philippines
Rizal
Manila, Philippines
Santo Toma Hospital
Manila, Philippines
Vietnam
Danang General
Danang, Vietnam
Hospital K, National Cancer Institute
Hanoi, Vietnam
Hue Central
Hue, Vietnam
Sponsors and Collaborators
International Breast Cancer Research Foundation
Investigators
Principal Investigator: Richard R. Love, M.D. International Breast Cancer Research Foundation

Responsible Party: International Breast Cancer Research Foundation
ClinicalTrials.gov Identifier: NCT00201851     History of Changes
Other Study ID Numbers: OSU-0483
First Posted: September 20, 2005    Key Record Dates
Results First Posted: April 29, 2015
Last Update Posted: April 29, 2015
Last Verified: April 2015

Keywords provided by International Breast Cancer Research Foundation:
Asian
Premenopausal
Women
Oophorectomy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Tamoxifen
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents