Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients With HER2-positive Unresectable or Metastatic Breast Cancer

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04857619
Collaborator
Parexel (Industry)
1,280
47
17.6
27.2
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: None (Observational study)

Detailed Description

The study will involve patients diagnosed with HER2-positive unresectable or mBC since the earlier date between the date of trastuzumab emtansine ([T-DM1] Kadcyla) becoming available through reimbursement or patient access programme as a valid local treatment option or 01 January 2017 and who received at least 1 LOT. The data will be collected from the date of diagnosis of unresectable or mBC (index date) to the end of follow-up (ie, until death, the last medical record entry, or date of data extraction, whichever is earlier). The study will not have any study-specific patient visits or a longitudinal follow-up. All available data will be extracted from patients' medical records or obtained from patients themselves after obtaining an informed consent unless a waiver is granted by the local Institutional Review Board (IRB)/Institutional Ethics Committee (IEC)/Ethics Committee (EC). The informed consent may be obtained at the time of patients routine clinical care visit to the oncology centre. The data on different types of treatment received by the patients, socio-demographics, and clinico-pathological characteristics will be extracted from patients medical records up to the date informed consent was obtained.

The study will be implemented at approximately 80 to 100 oncology centres spanning across 7 countries in the AstraZeneca (AZ) International Region (ie, non-US, non-European countries).

Two cohorts are planned for analysis to account for different study timelines. Cohort 1 will include all patients recruited outside China and Brazil, including Australia, Singapore, Taiwan, Korea, and Hong Kong special administrative region (SAR) (approximately 590 patients), and Cohort 2 will include patients from all countries including China and Brazil (approximately 1280 patients)

Study Design

Study Type:
Observational
Anticipated Enrollment :
1280 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
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
Actual Study Start Date :
May 14, 2021
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Retrospective: Cohort 1

All patients recruited outside China and Brazil, including Australia, Singapore, Taiwan, Korea, and Hong Kong special administrative region (SAR) and who are diagnosed with HER2-positive unresectable or mBC since either the date of T-DM1 (Kadcyla) availability through reimbursement or patient access programme that makes it a valid local treatment option for patients or 01 January 2017 and have received at least 1 LOT in the advanced setting will be included.

Other: None (Observational study)
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).
Other Names:
  • Observational study
  • Retrospective: Cohort 2

    Patients from all countries, including China and Brazil who are diagnosed with HER2-positive unresectable or mBC, since either the date of T-DM1 (Kadcyla) availability through reimbursement or patient access programme that makes it a valid local treatment option for patients or 01 January 2017 and have received at least 1 LOT in the advanced setting will be included.

    Other: None (Observational study)
    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).
    Other Names:
  • Observational study
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of patients receiving each treatment regimen with or without hormonal therapy in each LOT [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]]

      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.

    2. Duration of therapy (DoT) for each regimen in each LOT [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]]

      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.

    3. Percentage of patients receiving local and regional treatment for metastasis [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]]

      Assessment of local and regional treatment for metastasis (radiotherapy and/or surgery), bone protection therapy, and supportive/palliative care.

    Secondary Outcome Measures

    1. 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]]

      Descriptive statistics will be used to describe socio-demographic and clinico-pathological characteristics for the overall study.

    2. 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 disease progression of unresectable or mBC is defined as that documented in either the radiology report, pathology reports or clinician note as cancer progression.

    3. 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]]

      Real-world PFS is defined as the time from date of initiation of LOT to documented disease progression or death, whichever occurs first. Occurrence and date of disease progression in rwPFS will be determined from documentation within the patient record, such as pathology reports, imaging report notes, and statements about disease progression in the oncologist progress notes. Patients without an event (progression/death) will be censored at last date of assessment.

    4. 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]]

      Length of time from the date of diagnosis of unresectable or mBC or date of initiation of LOT to death due to any cause. If patient is not dead until the last record available or date of data extraction, then time-to-event will be calculated for that date. Patients who are known to be alive at the date of data collection will be censored at the date of data collection. Patients who are lost to follow up will be censored on the date they were last known to be alive (eg. date of last recorded hospital visit).

    5. 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]]

      The percentage of patients who have achieved real-world partial response (rwPR) and real-world complete response (rwCR) to therapy for each LOT.

    6. Real-world disease control 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]]

      The percentage of patients with rwCR, rwPR and real-world stable disease (rwSD) during treatment for each LOT

    7. Percentage of patients with adverse events (AEs) that led to treatment discontinuations or dose modifications, AEs of special interest (AESI) and deaths [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]]

      Assessment of safety and tolerability of different treatment regimens in patients with HER2-positive unresectable or mBC.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult female or male patients ≥18 years old or 'adults' according to 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 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 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

    Exclusion Criteria:
    • Patients with HER2-negative unresectable or mBC at index diagnosis

    • Patients with a change in HER2 status from positive to negative at 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 a 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 time of data collection for this study are participating or have participated in an interventional study that remains blinded

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Macquarie New South Wales Australia
    2 Research Site Newcastle New South Wales Australia
    3 Research Site St. Leonards New South Wales Australia
    4 Research Site Parramatta Australia
    5 Resarch Site Perth Australia
    6 Research Site Tasmania Australia 7000
    7 Research Site Fortaleza Ceara Brazil
    8 Research Site Cachoeiro de Itapemirim Espirito Santo Brazil
    9 Research Site Curitiba Parana Brazil
    10 Research Site Porto Alegre Rio Grande Do Sul Brazil
    11 Research Site Itajai Santa Catarina Brazil
    12 Research Site Santo Andre Sao Paulo Brazil
    13 Research Site Belo Horizonte Brazil
    14 Research Site Caxias do Sul Brazil
    15 Research Site Fortaleza Brazil
    16 Research Site Goiania Brazil
    17 Research Site Manaus Brazil
    18 Research Site Porto Alegre Brazil
    19 Research Site Salvador Brazil
    20 Research Site Salvador Brazil
    21 Research Site Sao Paulo Brazil
    22 Research Site Sao Paulo Brazil
    23 Research Site Changsha China
    24 Research Site Chongqing China
    25 Research Site Guangzhou China
    26 Research Site Haikou China
    27 Research Site Kunming China
    28 Research Site Nanchang China
    29 Research Site Nanjing China
    30 Research Site Shanghai Shi China
    31 Research Site Wuhan China
    32 Research Site Xian China
    33 Research Site Hong Kong Hong Kong
    34 Research Site Kowloon Hong Kong
    35 Research Site Goyang Korea, Republic of
    36 Research Site Incheon Korea, Republic of
    37 Research Site Seoul Korea, Republic of
    38 Research Site Seoul Korea, Republic of
    39 Research Site Singapore Singapore
    40 Research Site Singapore Singapore
    41 Research Site Kaohsiung Taiwan
    42 Research Site Taichung City Taiwan
    43 Research Site Taichung Taiwan
    44 Research Site Tainan County Taiwan
    45 Research Site Tainan Taiwan
    46 Research Site Taipei Taiwan
    47 Research Site Taipei Taiwan

    Sponsors and Collaborators

    • AstraZeneca
    • Parexel

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT04857619
    Other Study ID Numbers:
    • D9673R00005
    First Posted:
    Apr 23, 2021
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AstraZeneca
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 3, 2022