Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients With HER2-positive Unresectable or Metastatic Breast Cancer
A Multicountry, Multicentre, Non-interventional, Retrospective Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients With HER2-positive Unresectable or Metastatic Breast Cancer
1 other identifier
observational
763
6 countries
44
Brief Summary
This multicountry, multicenter, retrospective, non-interventional study involving patients diagnosed with HER2-positive unresectable or metastatic breast cancer mBC will be conducted to understand the demographic and clinico-pathological profile of the patients, diagnostic practices for human epidermal growth factor receptor 2 (HER2) status, current treatment landscape and sequencing of therapies, associated burden of toxicities with all lines of treatment (LOTs), and survival outcomes in the real-world setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2021
CompletedFirst Posted
Study publicly available on registry
April 23, 2021
CompletedStudy Start
First participant enrolled
May 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedJuly 11, 2024
July 1, 2024
1.5 years
April 21, 2021
July 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of patients receiving each treatment regimen with or without hormonal therapy in each LOT
Assessment of treatment patterns in patients diagnosed with HER2-positive unresectable or mBC. Line of treatment (LOT) is defined as one regimen, possibly a combination of several drugs, given from either the index diagnosis or disease progression until the treatment fails to control the disease, is not tolerated by the patient, the disease relapses/progresses, or death occurs.
Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Duration of therapy (DoT) for each regimen in each LOT
Assessment of length of time from initiation of therapy to permanent discontinuation. The DoT will be calculated as the time from the date of initiation of LOT to the stop of the treatment regimen for every LOT as per dates available in the medical record.
Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Percentage of patients receiving local and regional treatment for metastasis
Assessment of local and regional treatment for metastasis (radiotherapy and/or surgery), and bone protection therapy
Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Secondary Outcomes (7)
Demographic and clinico-pathological characteristics of patients with HER2-positive unresectable or mBC
Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Real-world disease progression
Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Real-world progression free survival (rwPFS)
Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Overall survival
Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Real-world objective response rate
Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
- +2 more secondary outcomes
Study Arms (1)
Retrospective
Patients who are diagnosed with HER2-positive unresectable or mBC and have received at least 1 LOT in the advanced setting will be included. Approximately a total of 570-830 patients will be enrolled in the study.
Interventions
The data on different types of treatment received by the patients, socio-demographics, and clinico-pathological characteristics and healthcare resource utilisation will be extracted from patients' medical records (both alive and deceased).
Eligibility Criteria
Study population will include patients who are diagnosed with HER2-positive unresectable or mBC and have received at least 1 LOT in the advanced setting.
You may qualify if:
- Adult female or male patients ≥18 years old or 'adults' according to the age of majority as defined by the local regulations
- Patient or next of kin/legal representative willing and able to provide written informed consent according to the local regulations unless a waiver is granted by the local IRB/IEC/EC
- Patients' medical records showing a diagnosis of HER2-positive unresectable or mBC (can be either de novo advanced disease, progression or recurrence of previous early-stage HER2-positive BC) since the available date of T-DM1 (Kadcyla) through reimbursement or patient access programme as a valid local treatment option or 01 January 2017, whichever is earlier and with the availability of at least 12 months of follow-up data (from the date of diagnosis of unresectable or mBC) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis
- Patients completing at least 1 LOT for HER2-positive unresectable or mBC
You may not qualify if:
- Patients with HER2-negative unresectable or mBC at index diagnosis
- Patients with a change in HER2 status from positive to negative at the progression from early-stage to advanced-stage disease (ie, shown on a repeat biopsy at diagnosis of advanced-stage disease) will be excluded (patients who change from HER2-positive to negative on repeat biopsy during treatment for advanced-stage disease may be included)
- Patients with concomitant cancer at the time of diagnosis of HER2-positive unresectable or mBC except for the non-metastatic non-melanoma skin cancers, or in situ, or benign neoplasms; a cancer is considered concomitant if it occurs within 5 years of HER2-positive breast cancer diagnosis
- Patients who at the time of data collection for this study are participating or have participated in an interventional study that remains blinded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Parexelcollaborator
Study Sites (44)
Research Site
Macquarie, New South Wales, 2109, Australia
Research Site
Newcastle, New South Wales, 2305, Australia
Research Site
Parramatta, New South Wales, 2145, Australia
Research Site
St Leonards, New South Wales, 2065, Australia
Research Site
Perth, Western Australia, Australia
Research Site
Manaus, Amazonas, 69056 037, Brazil
Research Site
Fortaleza, Ceará, 60336 232, Brazil
Research Site
Cachoeiro de Itapemirim, Espírito Santo, 29308 014, Brazil
Research Site
Salvador, Estado de Bahia, 40170 110, Brazil
Research Site
Salvador, Estado de Bahia, 41950 640, Brazil
Research Site
Curitiba, Paraná, 80040 170, Brazil
Research Site
Caxias do Sul, Rio Grande do Sul, 85020 450, Brazil
Research Site
Porto Alegre, Rio Grande do Sul, 90035 001, Brazil
Research Site
Porto Alegre, Rio Grande do Sul, 90610 000, Brazil
Research Site
Itajaí, Santa Catarina, 88301 220, Brazil
Research Site
Santo André, São Paulo, 09060 650, Brazil
Research Site
Fortaleza, 60416 130, Brazil
Research Site
Goiânia, 74605 070, Brazil
Research Site
Rio de Janeiro, 22250 905, Brazil
Research Site
São Paulo, 01321 001, Brazil
Research Site
São Paulo, 04502 001, Brazil
Research Site
Hong Kong, 150001, Hong Kong
Research Site
Hong Kong, Hong Kong
Research Site
Kowloon, Hong Kong
Research Site
Singapore, Central Singapore, 217562, Singapore
Research Site
Singapore, South East, 308433, Singapore
Research Site
Singapore, 119228, Singapore
Research Site
Singapore, 609606, Singapore
Research Site
Incheon, Incheon Gwang Yeogsi, 21565, South Korea
Research Site
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Research Site
Seoul, Seoul Teugbyeolsi, 03722, South Korea
Research Site
Seoul, Seoul Teugbyeolsi, 5505, South Korea
Research Site
Seoul, Seoul Teugbyeolsi, 6351, South Korea
Research Site
Seoul, Seoul Teugbyeolsi, 8308, South Korea
Research Site
Goyang, 10408, South Korea
Research Site
Seoul, 2841, South Korea
Research Site
Tainan County, Tainan, 71004, Taiwan
Research Site
Kaohsiung City, 824, Taiwan
Research Site
Taichung, 404, Taiwan
Research Site
Taichung, 40705, Taiwan
Research Site
Tainan, 70403, Taiwan
Research Site
Taipei, 100, Taiwan
Research Site
Taipei, 11217, Taiwan
Research Site
Taipei, 11490, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2021
First Posted
April 23, 2021
Study Start
May 14, 2021
Primary Completion
October 31, 2022
Study Completion
October 31, 2022
Last Updated
July 11, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.