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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: 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.

This study will be conducted in non-US and non-European countries including Australia, Brazil, Hong Kong, Korea, Singapore and Taiwan. The total number of patients in the study will be approximately a minimum of 570 and a maximum of 830 patients. The study will be implemented at approximately 50 to 100 oncology centres spanning across 6 countries in the AstraZeneca (AZ) International Region (ie, non-US, non-European countries).

• Study Type: Observational
• Enrollment (Actual): 763

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Macquarie, New South Wales, Australia, 2109
      • Research Site
    • Newcastle, New South Wales, Australia, 2305
      • Research Site
    • Parramatta, New South Wales, Australia, 2145
      • Research Site
    • St Leonards, New South Wales, Australia, 2065
      • Research Site
  • Western Australia
    • Perth, Western Australia, Australia
      • Research Site
• Brazil
  • Fortaleza, Brazil, 60416 130
    • Research Site
  • Goiania, Brazil, 74605 070
    • Research Site
  • Rio de Janeiro, Brazil, 22250 905
    • Research Site
  • Sao Paulo, Brazil, 01321 001
    • Research Site
  • Sao Paulo, Brazil, 04502 001
    • Research Site
  • Amazonas
    • Manaus, Amazonas, Brazil, 69056 037
      • Research Site
  • Bahia
    • Salvador, Bahia, Brazil, 40170 110
      • Research Site
    • Salvador, Bahia, Brazil, 41950 640
      • Research Site
  • Ceara
    • Fortaleza, Ceara, Brazil, 60336 232
      • Research Site
  • Espirito Santo
    • Cachoeiro de Itapemirim, Espirito Santo, Brazil, 29308 014
      • Research Site
  • Parana
    • Curitiba, Parana, Brazil, 80040 170
      • Research Site
  • Rio Grande Do Sul
    • Caxias do Sul, Rio Grande Do Sul, Brazil, 85020 450
      • Research Site
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035 001
      • Research Site
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610 000
      • Research Site
  • Santa Catarina
    • Itajai, Santa Catarina, Brazil, 88301 220
      • Research Site
  • Sao Paulo
    • Santo Andre, Sao Paulo, Brazil, 09060 650
      • Research Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Research Site
  • Hong Kong, Hong Kong, 150001
    • Research Site
  • Kowloon, Hong Kong
    • Research Site
• Korea, Republic of
  • Goyang, Korea, Republic of, 10408
    • Research Site
  • Seoul, Korea, Republic of, 2841
    • Research Site
  • Incheon Gwang Yeogsi
    • Incheon, Incheon Gwang Yeogsi, Korea, Republic of, 21565
      • Research Site
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
      • Research Site
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
      • Research Site
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 5505
      • Research Site
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 6351
      • Research Site
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 8308
      • Research Site
• Singapore
  • Singapore, Singapore, 119228
    • Research Site
  • Singapore, Singapore, 609606
    • Research Site
  • Central Singapore
    • Singapore, Central Singapore, Singapore, 217562
      • Research Site
  • South East
    • Singapore, South East, Singapore, 308433
      • Research Site
• Taiwan
  • Kaohsiung, Taiwan, 824
    • Research Site
  • Taichung, Taiwan, 404
    • Research Site
  • Taichung City, Taiwan, 40705
    • Research Site
  • Tainan, Taiwan, 70403
    • Research Site
  • Taipei, Taiwan, 100
    • Research Site
  • Taipei, Taiwan, 11217
    • Research Site
  • Taipei, Taiwan, 11490
    • Research Site
  • Tainan
    • Tainan County, Tainan, Taiwan, 71004
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic and clinico-pathological characteristics of patients with HER2-positive unresectable or mBC	Descriptive statistics will be used to describe socio-demographic and clinico-pathological characteristics for the overall study.	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	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.	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)	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.	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	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).	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	The percentage of patients who have achieved real-world partial response (rwPR) and real-world complete response (rwCR) to therapy for 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]
Real-world disease control rate	The percentage of patients with rwCR, rwPR and real-world stable disease (rwSD) during treatment for 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]
Percentage of Proportion of patients with AESIs that led to treatment discontinuations, hospitalisatons and deaths.	Assessment of safety and tolerability of different treatment regimens in 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]

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Parexel

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2021
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 23, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Retrospective; Human epidermal growth factor receptor 2 - positive
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: D9673R00005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No