Status:
COMPLETED
Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients With HER2-positive Unresectable or Metastatic Breast Cancer
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
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...
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 reimbur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
763 Patients enrolled
Trial Details
Trial ID
NCT04857619
Start Date
May 14 2021
End Date
October 31 2022
Last Update
July 11 2024
Active Locations (44)
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1
Research Site
Macquarie, New South Wales, Australia, 2109
2
Research Site
Newcastle, New South Wales, Australia, 2305
3
Research Site
Parramatta, New South Wales, Australia, 2145
4
Research Site
St Leonards, New South Wales, Australia, 2065