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Fulvestrant 500mg in Patients With Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT02909361
Recruitment Status : Unknown
Verified February 2019 by Xichun Hu, Fudan University.
Recruitment status was:  Recruiting
First Posted : September 21, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, Fudan University

Brief Summary:
Fulvestrant 500mg in Patients With Advanced Breast Cancer

Condition or disease Intervention/treatment
Metastatic Breast Cancer Drug: Fulvestrant

Detailed Description:
A multicenter, prospective study real-world to evaluate the safety profile and effectiveness in Chinese patients who received Fulvestrant 500mg as first-line endocrine treatment for Advanced breast cancer

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 53 Months
Official Title: A Multicenter, Prospective, Real-world Study to Evaluate the Safety Profile and Effectiveness in Chinese Patients Who Received Fulvestrant 500mg as First-line Endocrine Treatment for Advanced Breast Cancer
Actual Study Start Date : October 11, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant

Group/Cohort Intervention/treatment
Fulvestrant
500 mg on days 0, 14, and 28, and every 28 days thereafter
Drug: Fulvestrant
500 mg on days 0, 14, and 28, and every 28 days thereafter
Other Name: Fulvestrant Injection




Primary Outcome Measures :
  1. Incidence, nature and severity of all Adverse Events assessed by CTCAE V4.0 [ Time Frame: From date of randomization until the date of date of death from any cause or last visit, assessed up to 100 months. ]
    Incidence, nature and severity of all Adverse Events assessed by CTCAE V4.0


Secondary Outcome Measures :
  1. ORR [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months. ]
    Objective Response Rate

  2. CBR [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months. ]
    Clinical Benefit Rate

  3. PFS [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months. ]
    Progression Free Survival

  4. OS [ Time Frame: From date of randomization until the date of date of death from any cause or last visit, assessed up to 100 months. ]
    Overall Survival


Biospecimen Retention:   Samples With DNA
Plasma Sample will be collected at the time of study start and discontinuation base on the clinical practice.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese women with estrogen receptor positive, locally advanced or metastatic breast cancer.
Criteria

Inclusion Criteria:

  1. Chinese women with estrogen receptor positive, locally advanced or metastatic breast cancer who has already received Fulvestant 500mg treatment as determined by treating physician. Ovarian suppression in premenopausal women is permitted, including ovarian ablation and LHRHa.
  2. Histologically confirmed positive oestrogen receptor status (ER positive) of primary breast cancer or metastatic tumour tissue, according to the local laboratory parameters.
  3. Prior endocrine therapy for advanced disease was not permitted.
  4. The prescription of the Fulvestant is clearly separated from the decision to include the subject in the NIS, and is part of normal medical practice. The recruitment of the patient to the study should be within 1 month of the first Fulvestant injection.
  5. Provision of subject informed consent.

Exclusion Criteria:

  1. If participating in any controlled clinical trial, the subject cannot take part in this study.
  2. HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.
  3. Pervious regimen of endocrine therapy for advanced disease.
  4. More than one regimen of chemotherapy for advanced disease.
  5. Pregnancy and lactation.
  6. Severe hepatic impairment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02909361


Contacts
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Contact: Xichun Hu, MD, PhD 64175590 ext 85006 xchu2009@hotmail.com
Contact: Biyun Wang, MD 64175590 ext 85000 pro_wangbiyun@163.com

Locations
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China
Fudan University Cancer Hospital Recruiting
Shanghai, China, 200032
Contact: Xichun Hu, MD,PhD    64175590 ext 85006    xchu2009@hotmail.com   
Contact: Biyun Wang, MD    64175590 ext 85000    pro_wangbiyun@163.com   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Xichun Hu, MD, PhD Fudan University
Additional Information:

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Responsible Party: Xichun Hu, Director of department of medical oncology, Fudan University
ClinicalTrials.gov Identifier: NCT02909361    
Other Study ID Numbers: Fudan BR2016-21
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs