NCT00293540

Brief Summary

This study will determine if hormone receptor positive premenopausal metastatic breast cancer patients who undergo removal of the ovaries in mid-luteal versus mid-follicular phase have a longer survival.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
249

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Timeline
Completed

Started Feb 2006

Typical duration for phase_3 breast-cancer

Geographic Reach
10 countries

21 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

February 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2006

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 28, 2016

Completed
Last Updated

July 27, 2016

Status Verified

June 1, 2016

Enrollment Period

8 years

First QC Date

February 15, 2006

Results QC Date

May 19, 2016

Last Update Submit

June 28, 2016

Conditions

Breast Cancer

Keywords

metastaticsecondaryHormone Receptor-Positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Assess whether patients who undergo surgical oophorectomy in the history-estimated mid-luteal phase of their menstrual cycles survive longer than patients who undergo this surgery in the history-estimated mid-follicular phase of their menstrual cycles.

    Up to 9 years

Study Arms (2)

A

ACTIVE COMPARATOR

Surgical oophorectomy in history-estimated mid-luteal phase of menstrual cycle plus Tamoxifen

Procedure: oophorectomyDrug: Tamoxifen

B

ACTIVE COMPARATOR

Surgical oophorectomy in history-estimated mid-follicular phase of menstrual cycle plus Tamoxifen

Procedure: oophorectomyDrug: Tamoxifen

Interventions

oophorectomyPROCEDURE

Excision of an ovary

AB
TamoxifenDRUG

20 mg orally every day

Also known as: Nolvadex
AB

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Estrogen receptor or progesterone receptor positive breast cancer
  • Premenopausal with regular menstrual cycles

You may not qualify if:

  • Current oral contraceptives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Dhaka Medical College Hospital

Dhaka, Bangladesh

Location

4th Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Beijing Hospital

Beijing, China

Location

Cancer Institute

Beijing, China

Location

Choa Yang Capital Institute

Beijing, China

Location

National Railroad

Beijing, China

Location

Peoples Hospital

Beijing, China

Location

Qilu Hospital

Jinan, China

Location

Fudan University

Shanghai, China

Location

Nizam's Institute

Hyderabaad, India

Location

Dr. Ciptomanounkusumo General Hospital

Jakarta, Indonesia

Location

UN. Mayala

Kuala Lumpur, Malaysia

Location

National Institute of Oncology

Rabat, Morocco

Location

University College Hospital

Ibadan, Nigeria

Location

East Avenue Medical Center

Manila, Philippines

Location

Jose Reyes

Manila, Philippines

Location

Philippines General Hospital

Manila, Philippines

Location

Rizal

Manila, Philippines

Location

Vicente Sotto Hospital

Manila, Philippines

Location

Hospital K

Hanoi, Vietnam

Location

Related Publications (1)

  • Love RR, Hossain SM, Hussain MM, Mostafa MG, Laudico AV, Siguan SS, Adebamowo C, Sun JZ, Fei F, Shao ZM, Liu Y, Akram Hussain SM, Zhang B, Cheng L, Panigaro S, Walta F, Chuan JH, Mirasol-Lumague MR, Yip CH, Navarro NS Jr, Huang CS, Lu YS, Ferdousy T, Salim R, Akhter C, Nahar S, Uy G, Young GS, Hade EM, Jarjoura D. Luteal versus follicular phase surgical oophorectomy plus tamoxifen in premenopausal women with metastatic hormone receptor-positive breast cancer. Eur J Cancer. 2016 Jun;60:107-16. doi: 10.1016/j.ejca.2016.03.011. Epub 2016 Apr 20.

    PMID: 27107325DERIVED

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

OvariectomyTamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CastrationEndocrine Surgical ProceduresSurgical Procedures, OperativeUrogenital Surgical ProceduresGynecologic Surgical ProceduresStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

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

Study Officials

  • Richard R. Love, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific director

Study Record Dates

First Submitted

February 15, 2006

First Posted

February 17, 2006

Study Start

February 1, 2006

Primary Completion

February 1, 2014

Study Completion

March 1, 2015

Last Updated

July 27, 2016

Results First Posted

June 28, 2016

Record last verified: 2016-06

Locations

US(1)NG(1)IN(1)ID(1)VN(1)CN(8)BA(1)PH(5)MY(1)MO(1)