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Trial · Interventional

Status unknownPhase 4Registry data

Fulvestrant in Metastatic Breast Cancer

NCTNCT03591549 (opens ClinicalTrials.gov in a new tab)Other idRFTMBCPW
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
30 participants (estimated)
Sponsor
Assiut University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
Not stated
Start
1 Aug 2018 (estimated)
Primary completion
1 Aug 2021 (estimated)
Completion
1 Oct 2021 (estimated)
First posted
19 Jul 2018
Last update posted
23 Jul 2018
Conditions
Metastatic Breast Cancer

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20182019202020212022
  1. Ph 4

    Fulvestrant in Metastatic Breast Cancer

    NCT03591549

    est. 1 Aug 2018 to est. 1 Oct 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • FaslodexDrug
  • ZoladexDrug

Arms1

  • Experimental

    fulvestrant arm

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Progression free survival

    Time frame · three years

    Registry description

    time from start of the treatment till progression of the disease

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2012

Ovarian function suppression and fulvestrant as endocrine therapy in premenopausal women with metastatic breast cancer.

Bartsch et al. 2012European journal of cancer (Oxford, England : 1990)cited by 35

PMID 22459763DOI 10.1016/j.ejca.2012.03.002PUB-22459763

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
Female
Age
from 30 Years up to 55 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. Exclusion Criteria: * 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

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