Early Breast CancerRosHERNCT05217381
Real-World Data of Clinicopathological Characteristics and Management of Breast Cancer Patients According to HER2 Status
An observational study of Early Breast Cancer and Metastatic Breast Cancer, run by MedSIR at 7 sites in Spain.
Trial summary
This is a data-driven, retrospective, longitudinal, population- based, observational, multi-centered study using secondary data captured from congruent electronic health records (EHRs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
- How many people
- 18,533 participants
- Where
- 7 sitesSpain
- Study dates
- 22 Feb 2022to 20 Sep 2023
- 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: Patients with an initial confirmed diagnostic of breast cancer (early or locally advanced or de novo metastatic) managed in clinical practice during the predefined timeframe in the selected hospitals.
Who may be able to join
- Male or female patients who have at least 18 years of age at enrollment.
- Patients with initial diagnosis of early BC or locally advanced BC or de novo mBC between the 1st of January 2005 and the 31st of December 2021
- Pathologically documented BC for:
- HER2 receptor expression with a validated assay according to American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) recommendations at the time of diagnosis. HER2 receptor expression can be: o HER2-positive expression: defined as immunohistochemistry (IHC) 3+ or concurrent IHC 2+ with in situ hybridization (ISH) positive or HER2-low expression: defined as IHC 2+ with ISH-negative or IHC 1+ with ISH-negative or untested) or HER2-negative expression: defined as IHC: 0.
- Estrogen receptor [ER]- and/or progesterone receptor [PgR] with a validated assay according to ASCO/CAP guidelines at the time of diagnosis during early and/or advanced setting. ER/PgR expression can be: positive: ER or PgR ≥1% or negative: ER and PgR <1%
- Electronic Health Records (EHRs), with guaranteed data to meet requisites, about clinicopathological characteristics, type of surgery, treatment management, disease outcomes, and genomic profile. Centers that agree to participate must commit to include all subjects who meet the inclusion criteria, in order to reduce possible selection bias.
Who cannot join
- Medical charts at Hospital that cannot guarantee reliable and congruent EHRs.
- If sufficient data cannot be obtained from EHRs.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital del Mar
Barcelona
Hospital Sant Joan Despí - Moisès Broggi
Barcelona
Hospital Universitari Son Espases
la palma
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Fundación de Alcorcón
Madrid
Clínica Universidad de Navarra (CUN)
Pamplona
Hospital Universitario Marqués de Valdecilla
Santander
About this study
Official title: Retrospective Observational Study With Real-World Data to Assess Demographic and Clinicopathological Profiles, and Management of Breast Cancer Patients With Positive, Low or Negative Expression of HER2 in Spain
This is a data-driven, retrospective, longitudinal, population- based, observational, multi-centered study using secondary data captured from congruent electronic health records (EHRs).
Read the detailed description
Patients with pathologically documented an initial breast cancer diagnostic (early breast cancer (BC) or locally advanced BC or de novo metastatic BC) with documented human epidermal growth factor receptor 2 (HER2) and estrogen receptor (ER)/progesterone receptor (PgR) expression status at the time of diagnosis.
Data to determine the primary endpoint is estimated to be derived from the EHRs of over 2,000 patients that have an initial diagnosis of early BC, or locally advanced BC, or de novo metastatic BC (mBC) between the 1st of January 2005 and the 31st of December 2021, and who had at least one subsequent relapse until the 31st of December 2021 in at least 10 clinical centers.
The secondary endpoints utilize a larger collection of data from over 30,000 patients that have an initial diagnosis of early BC, or locally advanced BC, or de novo mBC between the 1st of January 2005 and the 31st of December 2021.
- Keywords
- Breast Cancer, Real-World Data, HER2 negative, HER2 positive, HER2 low, Artificial Intelligence
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Patients with an initial diagnostic of early breast cancer or locally advanced breast cancer or de novo metastatic breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of HER2 expression change between initial diagnosis versus any of the subsequent BC relapses
Change in HER2 expression between initial diagnosis of early BC or locally advanced BC or de novo mBC and any of subsequent BC relapses by IHC and/or ISH validated assays.
Measured: 180 months
Secondary outcomes (9)
Prevalence of changes in HER2 expression among different lines of treatment
HER2 expression changes as assessed by IHC (0+, 1+, 2+, 3+) and/or ISH (positive or negative) validated assays among different lines of treatment in the advanced setting, and/or among different metastatic sites.
Measured: 180 months
Description of the clinicopathological characteristics
Description of all the comprehensive clinicopathological characteristics (age at diagnosis, gender [male or female], baseline Eastern Cooperative Oncology Group [ECOG] performance status [0, 1, or 2], breast cancer pathological subtype at primary site, intrinsic subtype at primary and/or metastatic site by PAM50 test [including luminal A, luminal B, HER2-overexpressing, and basal-like], ER and PgR status [positive and/or negative] at primary and/or metastatic site, HER2 status by IHC and/or ISH testing [HER2-positive, HER2-low expressing, and HER2-negative status per ASCO-CAP guidelines] at primary and/or metastatic site, Ki67 at primary and/or metastatic site, endocrine resistance [primary or secondary]), metastatic sites (bone, brain, visceral involvement) nodal involvement, presence of measurable or evaluable disease per Response Evaluation Criteria In Solid Tumors (RECIST) in all patients enrolled.
Measured: 180 months
Evaluation of the disease management
Description of disease management and treatment patterns in all patients enrolled for gaining contemporary insights into HER2-low expressing breast cancer treatment trends that may inform clinicians for future management plans.
Measured: 180 months
Description of genomic profile
Identification of patients' genomic profile including DNA alterations and/or RNA expression of genes commonly disrupted in breast cancer, including driver, prognostic-related, and drug-response associated genes in tissue or liquid biopsies from all patients enrolled.
Measured: 180 months
Efficacy (OS)
Overall survival (OS) is defined as the time from date of primary treatment initiation to date of death due to any cause. In the absence of confirmation of death, survival time will be censored to last date the participant was known to be alive.
Measured: 180 months
Efficacy (ORR)
Objective response rate (ORR) is defined as the sum of complete response (CR) and partial response (PR) relative to the number of patients in the analysis set with measurable disease at baseline as per RECIST v.1.1.
Measured: 180 months
Efficacy (CBR)
Clinical benefit rate (CBR) is defined as the proportion of participants with CR, PR or stable disease (SD) ≥24 weeks relative to the number of patients in the analysis set as per RECIST v.1.1.
Measured: 180 months
Efficacy (PFS)
Progression-free survival (PFS) is defined as the period of time from treatment initiation to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined locally by the investigator using RECIST v.1.1.
Measured: 180 months
Efficacy (DoR)
Duration of response (DoR) is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression, death due to any cause or treatment discontinuation, whichever occurs first as per RECIST v.1.1.
Measured: 180 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start22 Feb 2022
- Primary completion20 Sep 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early 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
- Retrospective
- Enrolment
- 18,533 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedSIR
- Sponsor type
- University, hospital or other
- Collaborators
- Daiichi Sankyo, AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Javier Cortés, MD, PhD, Principal investigator, MedSIR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217381
- Sponsor's protocol ID
- MEDOPP367
- Acronym
- RosHER
- Status last verified
- Sep 2023
- First submitted
- 19 Jan 2022
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Study With Real-World Data to Assess Demographic and Clinicopathological Profiles, and Management of Breast Cancer Patients With Positive, Low or Negative Expression of HER2 in Spain
- ClinicalTrials.gov ID
- NCT05217381
- Acronym / sponsor ID
- RosHER / MEDOPP367
- Keywords
- Breast Cancer, Real-World Data, HER2 negative, HER2 positive, HER2 low, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18,533 participants (actual)
- Lead sponsor
- MedSIRUniversity, hospital or other
- Collaborators
- Daiichi Sankyo, AstraZeneca
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 1 Feb 2022 (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.
This is a data-driven, retrospective, longitudinal, population- based, observational, multi-centered study using secondary data captured from congruent electronic health records (EHRs).
Detailed description
Patients with pathologically documented an initial breast cancer diagnostic (early breast cancer (BC) or locally advanced BC or de novo metastatic BC) with documented human epidermal growth factor receptor 2 (HER2) and estrogen receptor (ER)/progesterone receptor (PgR) expression status at the time of diagnosis.
Data to determine the primary endpoint is estimated to be derived from the EHRs of over 2,000 patients that have an initial diagnosis of early BC, or locally advanced BC, or de novo metastatic BC (mBC) between the 1st of January 2005 and the 31st of December 2021, and who had at least one subsequent relapse until the 31st of December 2021 in at least 10 clinical centers.
The secondary endpoints utilize a larger collection of data from over 30,000 patients that have an initial diagnosis of early BC, or locally advanced BC, or de novo mBC between the 1st of January 2005 and the 31st of December 2021.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Patients with an initial diagnostic of early breast cancer or locally advanced breast cancer or de novo metastatic breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an initial confirmed diagnostic of breast cancer (early or locally advanced or de novo metastatic) managed in clinical practice during the predefined timeframe in the selected hospitals.
Key inclusion criteria (6 listed)
- Male or female patients who have at least 18 years of age at enrollment.
- Patients with initial diagnosis of early BC or locally advanced BC or de novo mBC between the 1st of January 2005 and the 31st of December 2021
- Pathologically documented BC for:
- Electronic Health Records (EHRs), with guaranteed data to meet requisites, about clinicopathological characteristics, type of surgery, treatment management, disease outcomes, and genomic profile. Centers that agree to participate must commit to include all subjects who meet the inclusion criteria, in order to reduce possible selection bias.
Key exclusion criteria (2 listed)
- Medical charts at Hospital that cannot guarantee reliable and congruent EHRs.
- If sufficient data cannot be obtained from EHRs.
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
Prevalence of HER2 expression change between initial diagnosis versus any of the subsequent BC relapses
Time frame: 180 months
Change in HER2 expression between initial diagnosis of early BC or locally advanced BC or de novo mBC and any of subsequent BC relapses by IHC and/or ISH validated assays.
9 secondary outcomes
Prevalence of changes in HER2 expression among different lines of treatment
Time frame: 180 months
Description of the clinicopathological characteristics
Time frame: 180 months
Evaluation of the disease management
Time frame: 180 months
Description of genomic profile
Time frame: 180 months
Efficacy (OS)
Time frame: 180 months
Efficacy (ORR)
Time frame: 180 months
Efficacy (CBR)
Time frame: 180 months
Efficacy (PFS)
Time frame: 180 months
Efficacy (DoR)
Time frame: 180 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
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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.
Javier Cortés, MD, PhD principal investigator
MedSIR
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Breast Cancer and Metastatic Breast Cancer, run by MedSIR at 7 sites in Spain.
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 6 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: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of HER2 expression change between initial diagnosis versus any of the subsequent BC relapses (time frame: 180 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 25 Sep 2023.