Metastatic Breast CancerMBCNCT04247035
Τreatment Standards and Outcomes of Patients With ER/PR Positive, HER2-negative Metastatic Breast Cancer
An observational study of Metastatic Breast Cancer, run by Hellenic Society of Medical Oncology at 1 site in Greece.
Trial summary
To capture the treatment patterns and clinical characteristics of patients with ER/PR positive, HER2-negative MBC in Greece Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- How many people
- 300 participants
- Where
- 1 siteGreece
- Study dates
- 31 Jan 2019to 31 Jan 2024
- How long will I take part?
- 3 Years
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Women with histological confirmed ER/PR positive, HER2-negative MBC
Who may be able to join
- Women with histological confirmed ER/PR positive, HER2-negative MBC
- Age >18 years old
- Patients initiating first or second line therapy for ER/PR positive, HER2-negative MBC
- Adequate hematologic, renal and hepatic function
- Signed informed consent (ICF)
Who cannot join
- Active malignancy other than MBC
- Active infection
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Hellenic Society of Medical Oncology
Athens, 11475
Kalliopi Sarikaki, SC, +302106457971, psarikaki@hesmo.gr
About this study
Official title: Non-Interventional, Multi-center Registry of Recording of Treatment Standards and Outcomes of Patients With ER/PR Positive, HER2-negative Metastatic Breast Cancer
- To capture the treatment patterns and clinical characteristics of patients with ER/PR positive, HER2-negative MBC in Greece
Read the detailed description
- To capture the treatment patterns and clinical characteristics of patients with ER/PR positive, HER2-negative MBC in Greece
- To evaluate the outcome of patients per treatment line (objective response, progression free survival, time to disease progression per line of therapy), overall survival
- To record adverse events per line of therapy
- To recording of the causes of treatment discontinuation per line of therapy
- Conditions
- Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the outcome per treatment line
To evaluate the outcome of patients per treatment line (objective response, progression free survival, time to disease progression per line of therapy), overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start31 Jan 2019
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Jan 2024 (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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hellenic Society of Medical Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ioannis Boukovinas, Dr /Phd, Principal investigator, HeSMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247035
- Sponsor's protocol ID
- Metastatic Breast Cancer
- Acronym
- MBC
- Status last verified
- Feb 2021
- First submitted
- 24 Jan 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional, Multi-center Registry of Recording of Treatment Standards and Outcomes of Patients With ER/PR Positive, HER2-negative Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT04247035
- Acronym / sponsor ID
- MBC / Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hellenic Society of Medical OncologyUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 29 Jan 2020 (actual)
- 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.
- To capture the treatment patterns and clinical characteristics of patients with ER/PR positive, HER2-negative MBC in Greece
Detailed description
- To capture the treatment patterns and clinical characteristics of patients with ER/PR positive, HER2-negative MBC in Greece
- To evaluate the outcome of patients per treatment line (objective response, progression free survival, time to disease progression per line of therapy), overall survival
- To record adverse events per line of therapy
- To recording of the causes of treatment discontinuation per line of therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with histological confirmed ER/PR positive, HER2-negative MBC
Key inclusion criteria (5 listed)
- Women with histological confirmed ER/PR positive, HER2-negative MBC
- Age >18 years old
- Patients initiating first or second line therapy for ER/PR positive, HER2-negative MBC
- Adequate hematologic, renal and hepatic function
- Signed informed consent (ICF)
Key exclusion criteria (2 listed)
- Active malignancy other than MBC
- Active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the outcome per treatment line
Time frame: 5 years
To evaluate the outcome of patients per treatment line (objective response, progression free survival, time to disease progression per line of therapy), overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
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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.
Ioannis Boukovinas, Dr /Phd principal investigator
HeSMO
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 Hellenic Society of Medical Oncology at 1 site in Greece.
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 2 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 10 Feb 2021. 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 Greece. 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?
Contact Sofia Agelaki, prof (+302106457971, agelakisofia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the outcome per treatment line (time frame: 5 years). 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 10 Feb 2021.