Real-World Data of Clinicopathological Characteristics and Management of Patients With HER2+ Breast Cancer (RosHER)

Sponsor

MedSIR (Other)

Overall Status

Recruiting

CT.gov ID

NCT05217381

Collaborator

Daiichi Sankyo, Inc. (Industry), AstraZeneca (Industry)

30,000

Enrollment

Locations

10.3

Anticipated Duration (Months)

6000

Patients Per Site

585.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a data-driven, retrospective, longitudinal, population- based, observational, multi-centered study using secondary data captured from congruent electronic health records (EHRs).

Condition or Disease	Intervention/Treatment	Phase
Early Breast Cancer Metastatic Breast Cancer

Detailed Description

Patients with pathologically documented locally recurrent or inoperable advanced breast cancer that progressed during or after prior treatment for primary invasive breast cancer. Documented HER2 and estrogen receptor (ER)/progesterone receptor (PgR) expression status evaluated both in the invasive component of the primary carcinoma of the breast (in the early setting) and primary or metastatic lesion (in the advanced setting) is required.

Data to determine the primary endpoint is estimated to be derived from the EHRs of over 2,000 patients that have been diagnosed of early breast cancer between 2005 and 2020, and who developed locally recurrent or advanced inoperable breast cancer between January 2015 and January 2020 in at least 10 clinical centers.

The secondary endpoints utilize a larger collection of data from over 30,000 patients with early and/or advanced breast cancer diagnose between 2015 and 2020.

Study Design

Study Type:

Observational

Anticipated Enrollment :

30000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Feb 22, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 Patients with pathologically documented locally recurrent or inoperable advanced breast cancer that progressed during or after prior treatment for primary invasive breast cancer

Outcome Measures

Primary Outcome Measures

Prevalence of HER2 expression change [180 months]
Change in HER2 expression between primary and advanced breast cancer by IHC and/or ISH validated assays.

Secondary Outcome Measures

Prevalence of changes in HER2 expression among different lines of treatment [180 months]
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.
Description of the clinicopathological characteristics [180 months]
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.
Evaluation of the disease management [180 months]
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.
Description of genomic profile [180 months]
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.
Efficacy (OS) [180 months]
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.
Efficacy (ORR) [180 months]
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.
Efficacy (CBR) [180 months]
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.
Efficacy (PFS) [180 months]
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.
Efficacy (DoR) [180 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female patients who have at least 18 years of age at enrollment.
Patients with locally recurrent or advanced inoperable breast cancer diagnosed between January 2015 and January 2020.

AND/OR

Patients with early breast cancer diagnosed between 2005 and 2020.

Pathologically documented breast cancer that:

Has a history of 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) with a validated assay according to American Society Of Clinical Oncology-College of American Pathologists (ASCO/CAP) recommendations at the time of diagnose, during early and/or advanced setting.

Note: In patients with locally recurrent or advanced inoperable breast cancer, HER2 expression should have been performed on the most recent tumor biopsy since last progression from metastatic tissue.

Is documented as hormone receptor (HR)-positive (either estrogen receptor [ER]- and/or progesterone receptor [PgR]-positive [ER or PgR ≥1%]) or HR- negative (ER- and PgR-negative [ER and PgR <1%] per ASCO/CAP guidelines during early and/or advanced setting.

Has documented progression during or after prior treatment in the adjuvant or neo-adjuvant setting.

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.

Exclusion criteria:

Medical charts at Hospital that cannot guarantee reliable and congruent EHRs.
If sufficient data cannot be obtained from EHRs.

Contacts and Locations

Locations

	Site	City	Country
1	Hospital del Mar	Barcelona	Spain
2	Hospital Sant Joan Despí - Moisès Broggi	Barcelona	Spain
3	Hospital Universitari Son Espases	La Palma	Spain
4	Hospital Universitario 12 de Octubre	Madrid	Spain
5	Hospital Universitario Fundación de Alcorcón	Madrid	Spain