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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00201851
First received: September 12, 2005
Last updated: November 22, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Drug: Tamoxifen
Procedure: Surgery: Oophorectomy
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • evaluate the impact of the timing in the menstrual cycle of simultaneous mastectomy and oophorectomy on disease-free survival from operable breast cancer. [ Time Frame: two- to three-year accrual and initial two or more years of follow-up period ] [ Designated as safety issue: No ]

Estimated Enrollment: 1
Study Start Date: January 2004
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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)
  • FNA diagnosis
  • Stage II-IIIA HR+ invasive breast cancer
  • No prior radiation or chemotherapy
  • Must be surgical candidate for bilateral oophorectomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00201851

Locations
Morocco
National Institute of Oncology
Rabat, Morocco
Philippines
Vicente Soto Memorial Medical Center
Cebu, Philippines
Philippine General Hospital
Manila, Philippines
East Avenue Medical Center
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
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Richard R. Love, M.D. Ohio State University
  More Information

Additional Information:
Jamesline  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00201851     History of Changes
Other Study ID Numbers: OSU-0483
Study First Received: September 12, 2005
Last Updated: November 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
Asian
Premenopausal
Women
Oophorectomy

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

ClinicalTrials.gov processed this record on May 16, 2013