NCT03591549

Brief Summary

This is a prospective study of the role of fulvestrant in combination with ovarian function suppression as first-line therapy in premenopausal patients with metastatic hormone receptor-positive breast cancer.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2018

Typical duration for phase_4

Status
unknown

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

First Submitted

Initial submission to the registry

July 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

3 years

First QC Date

July 9, 2018

Last Update Submit

July 20, 2018

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    time from start of the treatment till progression of the disease

    three years

Study Arms (1)

fulvestrant arm

EXPERIMENTAL

patients will receive fulvestrant + zoladex intramuscular monthly with an assessment every three months to assess the response and progression

Drug: FaslodexDrug: Zoladex

Interventions

FaslodexDRUG

intramuscular injection monthly

fulvestrant arm
ZoladexDRUG

intramuscular injection monthly

fulvestrant arm

Eligibility Criteria

Age30 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with age 30-50 years old (premenopause).
  • Histological confirmation of metastatic disease.
  • Hormonal receptor positive.
  • Endocrine therapy for early disease had been completed more than 12 months before the study (patients who was not resistance to hormonal therapy).
  • Metastatic breast cancer at presentation.
  • Patients had not received any previous systemic therapy for metastatic disease.
  • Performance status (ECOG) 0-2.

You may not qualify if:

  • Patient \>55 years old.
  • Non-histologically diagnosed.
  • Hormonal receptor negative
  • Non metastatic
  • received previous line therapy in the metastatic setting.
  • Patient with performance \>2.
  • Patient with co-morbidity
  • Patients with brain metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Bartsch R, Bago-Horvath Z, Berghoff A, DeVries C, Pluschnig U, Dubsky P, Rudas M, Mader RM, Rottenfusser A, Fitzal F, Gnant M, Zielinski CC, Steger GG. Ovarian function suppression and fulvestrant as endocrine therapy in premenopausal women with metastatic breast cancer. Eur J Cancer. 2012 Sep;48(13):1932-8. doi: 10.1016/j.ejca.2012.03.002. Epub 2012 Mar 27.

    PMID: 22459763BACKGROUND

  • Wakeling AE, Dukes M, Bowler J. A potent specific pure antiestrogen with clinical potential. Cancer Res. 1991 Aug 1;51(15):3867-73.

    PMID: 1855205BACKGROUND

  • Fawell SE, White R, Hoare S, Sydenham M, Page M, Parker MG. Inhibition of estrogen receptor-DNA binding by the "pure" antiestrogen ICI 164,384 appears to be mediated by impaired receptor dimerization. Proc Natl Acad Sci U S A. 1990 Sep;87(17):6883-7. doi: 10.1073/pnas.87.17.6883.

    PMID: 2395882BACKGROUND

  • Wakeling AE. Similarities and distinctions in the mode of action of different classes of antioestrogens. Endocr Relat Cancer. 2000 Mar;7(1):17-28. doi: 10.1677/erc.0.0070017. No abstract available.

    PMID: 10808193BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

FulvestrantGoserelin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsGonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 9, 2018

First Posted

July 19, 2018

Study Start

August 1, 2018

Primary Completion

August 1, 2021

Study Completion

October 1, 2021

Last Updated

July 23, 2018

Record last verified: 2018-07