Metastatic Breast CancerNCT02909361
Fulvestrant 500mg in Patients With Advanced Breast Cancer
An observational study of Metastatic Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
Fulvestrant 500mg in Patients With Advanced Breast Cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Fulvestrant
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2017to Oct 2022
- How long will I take part?
- 53 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Chinese women with estrogen receptor positive, locally advanced or metastatic breast cancer.
Who may be able to join
- 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.
- Histologically confirmed positive oestrogen receptor status (ER positive) of primary breast cancer or metastatic tumour tissue, according to the local laboratory parameters.
- Prior endocrine therapy for advanced disease was not permitted.
- 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.
- Provision of subject informed consent.
Who cannot join
- If participating in any controlled clinical trial, the subject cannot take part in this study.
- HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.
- Pervious regimen of endocrine therapy for advanced disease.
- More than one regimen of chemotherapy for advanced disease.
- Pregnancy and lactation.
- Severe hepatic impairment.
Trial locations and contacts
1 site in 1 country.
About this study
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
Fulvestrant 500mg in Patients With Advanced Breast Cancer
Read the 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
- Conditions
- Metastatic Breast Cancer
- Being tested
- Fulvestrant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FulvestrantDrug
Also called Fulvestrant Injection
500 mg on days 0, 14, and 28, and every 28 days thereafter
| Study group | Role | What they receive |
|---|---|---|
| Fulvestrant | 500 mg on days 0, 14, and 28, and every 28 days thereafter Receives: Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, nature and severity of all Adverse Events assessed by CTCAE V4.0
Incidence, nature and severity of all Adverse Events assessed by CTCAE V4.0
Measured: From date of randomization until the date of date of death from any cause or last visit, assessed up to 100 months.
Secondary outcomes (4)
ORR
Objective Response Rate
Measured: 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.
CBR
Clinical Benefit Rate
Measured: 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.
PFS
Progression Free Survival
Measured: 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.
OS
Overall Survival
Measured: From date of randomization until the date of date of death from any cause or last visit, assessed up to 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start11 Oct 2017
- Primary completionJun 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 53 Months
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xichun Hu, Fudan University
- Investigators
- Xichun Hu, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909361
- Sponsor's protocol ID
- Fudan BR2016-21
- Status last verified
- Apr 2022
- First submitted
- 12 Sep 2016
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02909361
- Acronym / sponsor ID
- Fudan BR2016-21
- Conditions
- Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fulvestrant 500mg in Patients With Advanced Breast Cancer
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 53 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fulvestrant | – | Drug: Fulvestrant500 mg on days 0, 14, and 28, and every 28 days thereafter |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese women with estrogen receptor positive, locally advanced or metastatic breast cancer.
Key inclusion criteria (5 listed)
- 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.
- Histologically confirmed positive oestrogen receptor status (ER positive) of primary breast cancer or metastatic tumour tissue, according to the local laboratory parameters.
- Prior endocrine therapy for advanced disease was not permitted.
- 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.
- Provision of subject informed consent.
Key exclusion criteria (6 listed)
- If participating in any controlled clinical trial, the subject cannot take part in this study.
- HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.
- Pervious regimen of endocrine therapy for advanced disease.
- More than one regimen of chemotherapy for advanced disease.
- Pregnancy and lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FulvestrantAlso: Fulvestrant Injection500 mg on days 0, 14, and 28, and every 28 days thereafter | Drug | Fulvestrant |
Primary outcome
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
4 secondary outcomes
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xichun Hu, MD, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.