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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04857619
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : August 3, 2022
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
AstraZeneca

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
Metastatic Breast Cancer 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)

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort 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 Name: 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 Name: Observational study




Primary Outcome Measures :
  1. Percentage of patients receiving each treatment regimen with or without hormonal therapy in each LOT [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857619


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
Show Show 47 study locations
Sponsors and Collaborators
AstraZeneca
Parexel
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04857619    
Other Study ID Numbers: D9673R00005
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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.

URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Human epidermal growth factor receptor 2 - positive
Retrospective
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases