An observational study in Early Breast Cancer, Metastatic Breast Cancer and Locally Advanced Breast Cancer, sponsored by MedSIR. Completed at 7 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-25.
Sponsored by MedSIR · Observational
This is a data-driven, retrospective, longitudinal, population- based, observational, multi-centered study using secondary data captured from congruent electronic health records (EHRs).
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 18,533 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →MedSIR is the lead sponsor of 55 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Pathologically documented BC for:
Exclusion criteria:
Patients with an initial diagnostic of early breast cancer or locally advanced breast cancer or de novo metastatic breast cancer
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.
Time frame: 180 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 180 months
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
MedSIR