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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
International Breast Cancer Research Foundation
ClinicalTrials.gov Identifier:
NCT00201851
First received: September 12, 2005
Last updated: April 13, 2015
Last verified: April 2015
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel 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:


Further study details as provided by International Breast Cancer Research Foundation:

Primary Outcome Measures:
  • Disease-free Survival [ Time Frame: two- to three-year accrual and initial two or more years of follow-up period ] [ Designated as safety issue: No ]
    5-year disease-free survival


Enrollment: 740
Study Start Date: January 2004
Study Completion Date: May 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
  More Information

No publications provided

Responsible Party: International Breast Cancer Research Foundation
ClinicalTrials.gov Identifier: NCT00201851     History of Changes
Other Study ID Numbers: OSU-0483
Study First Received: September 12, 2005
Results First Received: March 31, 2015
Last Updated: April 13, 2015
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 03, 2015