NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: AstraZeneca
Conditions: Metastatic Breast Cancer
Interventions: None (Observational study)
Countries: Australia, Brazil, Hong Kong, Singapore, South Korea, Taiwan
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: OBSERVATIONAL
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
- Macquarie, New South Wales, Australia
- Newcastle, New South Wales, Australia
- Parramatta, New South Wales, Australia
- St Leonards, New South Wales, Australia
- Perth, Western Australia, Australia
- Manaus, Amazonas, Brazil
- Fortaleza, Ceará, Brazil
- Cachoeiro de Itapemirim, Espírito Santo, Brazil
- Salvador, Estado de Bahia, Brazil
- Salvador, Estado de Bahia, Brazil
- Curitiba, Paraná, Brazil
- Caxias do Sul, Rio Grande do Sul, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Itajaí, Santa Catarina, Brazil
- Santo André, São Paulo, Brazil
- Fortaleza, Brazil
- Goiânia, Brazil
- Rio de Janeiro, Brazil
- São Paulo, Brazil
- São Paulo, Brazil
- Hong Kong, Hong Kong
- Hong Kong, Hong Kong
- Kowloon, Hong Kong
- Singapore, Central Singapore, Singapore
- Singapore, South East, Singapore
- Singapore, Singapore
- Singapore, Singapore
- Incheon, Incheon Gwang Yeogsi, South Korea
- Seoul, Seoul Teugbyeolsi, South Korea
- + 14 more on CT.gov