NCT00201851

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
740

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline
Completed

Started Jan 2004

Typical duration for phase_3 breast-cancer

Geographic Reach
3 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2 years until next milestone

Results Posted

Study results publicly available

April 29, 2015

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

7.9 years

First QC Date

September 12, 2005

Results QC Date

March 31, 2015

Last Update Submit

April 13, 2015

Conditions

Breast Cancer

Keywords

AsianPremenopausalWomenOophorectomy

Outcome Measures

Primary Outcomes (1)

  • Disease-free Survival

    5-year disease-free survival

    two- to three-year accrual and initial two or more years of follow-up period

Study Arms (3)

Immediate surgery

ACTIVE COMPARATOR

Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen

Drug: TamoxifenProcedure: Surgery: Oophorectomy

Scheduled surgery

EXPERIMENTAL

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

Drug: TamoxifenProcedure: Surgery: Oophorectomy

Immediate Surgery - nonrandomized

OTHER

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

Drug: TamoxifenProcedure: Surgery: Oophorectomy

Interventions

TamoxifenDRUG

20 mg po daily x 5 years

Also known as: Nolvadex®
Immediate Surgery - nonrandomizedImmediate surgeryScheduled surgery
Surgery: OophorectomyPROCEDURE

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)

Also known as: ovary removal surgery
Immediate Surgery - nonrandomizedImmediate surgeryScheduled surgery

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

National Institute of Oncology

Rabat, Morocco

Location

Vicente Soto Memorial Medical Center

Cebu, Philippines

Location

East Avenue Medical Center

Manila, Philippines

Location

Philippine General Hospital

Manila, Philippines

Location

Rizal

Manila, Philippines

Location

Santo Toma Hospital

Manila, Philippines

Location

Danang General

Da Nang, Vietnam

Location

Hospital K, National Cancer Institute

Hanoi, Vietnam

Location

Hue Central

Huế, Vietnam

Location

Related Publications (1)

  • Hade EM, Young GS, Love RR. Follow up after sample size re-estimation in a breast cancer randomized trial for disease-free survival. Trials. 2019 Aug 23;20(1):527. doi: 10.1186/s13063-019-3632-9.

    PMID: 31443726DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

TamoxifenOvariectomy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCastrationEndocrine Surgical ProceduresSurgical Procedures, OperativeUrogenital Surgical ProceduresGynecologic Surgical Procedures

Results Point of Contact

Title
Richard R. Love
Organization
International Breast Cancer Research Foundation
richardibcrf@gmail.com
608-698-7881

Study Officials

  • Richard R. Love, M.D.

    International Breast Cancer Research Foundation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

January 1, 2004

Primary Completion

December 1, 2011

Study Completion

May 1, 2013

Last Updated

April 29, 2015

Results First Posted

April 29, 2015

Record last verified: 2015-04

Locations

MO(1)VN(3)PH(5)