Clinical trial NCT04857619: Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients With HER2-positive Unresectable or Metastatic Breast Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Keywords: Human epidermal growth factor receptor 2 - positive
Retrospective
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2021-04-23
Enrollment: 763
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients receiving each treatment regimen with or without hormonal therapy in each LOT
timeFrame: 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]
measure: Duration of therapy (DoT) for each regimen in each LOT
timeFrame: 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]
measure: Percentage of patients receiving local and regional treatment for metastasis
timeFrame: 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:
measure: Demographic and clinico-pathological characteristics of patients with HER2-positive unresectable or mBC
timeFrame: 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]
measure: Real-world disease progression
timeFrame: 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]
measure: Real-world progression free survival (rwPFS)
timeFrame: 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]
measure: Overall survival
timeFrame: 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]
measure: Real-world objective response rate
timeFrame: 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]
measure: Real-world disease control rate
timeFrame: 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]
measure: Percentage of Proportion of patients with AESIs that led to treatment discontinuations, hospitalisatons and deaths.
timeFrame: 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]
Other outcomes:
Locations:
city: Macquarie
country: Australia
facility: Research Site
state: New South Wales
city: Newcastle
country: Australia
facility: Research Site
state: New South Wales
city: Parramatta
country: Australia
facility: Research Site
state: New South Wales
city: St Leonards
country: Australia
facility: Research Site
state: New South Wales
city: Perth
country: Australia
facility: Research Site
state: Western Australia
city: Manaus
country: Brazil
facility: Research Site
state: Amazonas
city: Salvador
country: Brazil
facility: Research Site
state: Bahia
city: Salvador
country: Brazil
facility: Research Site
state: Bahia
city: Fortaleza
country: Brazil
facility: Research Site
state: Ceara
city: Cachoeiro de Itapemirim
country: Brazil
facility: Research Site
state: Espirito Santo
city: Curitiba
country: Brazil
facility: Research Site
state: Parana
city: Caxias do Sul
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: Itajai
country: Brazil
facility: Research Site
state: Santa Catarina
city: Santo Andre
country: Brazil
facility: Research Site
state: Sao Paulo
city: Fortaleza
country: Brazil
facility: Research Site
city: Goiania
country: Brazil
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Kowloon
country: Hong Kong
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
state: Incheon Gwang Yeogsi
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Seoul Teugbyeolsi
city: Goyang
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
state: Central Singapore
city: Singapore
country: Singapore
facility: Research Site
state: South East
city: Singapore
country: Singapore
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Tainan County
country: Taiwan
facility: Research Site
state: Tainan
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung City
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
Study officials:
References: