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Fulvestrant in Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03591549
Recruitment Status : Not yet recruiting
First Posted : July 19, 2018
Last Update Posted : July 23, 2018
Information provided by (Responsible Party):
AIMekkawy, Assiut University

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Faslodex Drug: Zoladex Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Fulvestrant in The Treatment of Metastatic Breast Cancer in Premenopausal Women
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: fulvestrant arm
patients will receive fulvestrant + zoladex intramuscular monthly with an assessment every three months to assess the response and progression
Drug: Faslodex
intramuscular injection monthly

Drug: Zoladex
intramuscular injection monthly

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: three years ]
    time from start of the treatment till progression of the disease

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female
Accepts Healthy Volunteers:   No

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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Responsible Party: AIMekkawy, Principal investigator, Assiut University Identifier: NCT03591549    
Other Study ID Numbers: RFTMBCPW
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs