Breast Cancer
Conditions
Brief summary
This is a single arm prospective, observational multi-centre study in patients with HER-2 positive breast cancer who have completed concurrent chemotherapy with pertuzumab and trastuzumab administered IV and are currently receiving or will be receiving maintenance therapy with PH FDC SC and have at least 6 cycles of therapy expected with PH FDC SC to conclude pre-established oncological treatment. Treatment of the patients will not be determined or assigned by study procedures but will be based on normal clinical practice. Only data available per clinical practice will be collected within this study. The treatment decision must have been taken prior to and irrespective of patient's inclusion in the study.
Detailed description
Primary objective • The primary objective of the study is to evaluate the safety of pertuzumab and trastuzumab (PH) fixed-dose combination (FDC) for subcutaneous (SC) administration in patients with HER-2 positive breast cancer who have completed concurrent chemotherapy with pertuzumab and trastuzumab administered intravenously (IV) and are currently receiving or will be receiving maintenance therapy with PH FDC SC. Secondary objectives The secondary exploratory objectives of the study are: * To assess the patient's social cost saving by means of a specific questionnaire; * To assess the patient's health related quality of life (HRQOL).
Interventions
None listed
Sponsors
Fondazione Oncotech
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent of the patient; * Female and male patients aged ≥ 18 years (no upper limit); * Patients with HER-2 positive breast cancer, who have completed concurrent chemotherapy with pertuzumab and trastuzumab IV and are currently receiving or will be receiving maintenance therapy with PH FDC SC according to locally approved indication; * Patients with expected at least 6 cycles of therapy with PH FDC SC to conclude pre-established oncological treatment;
Exclusion criteria
* Life expectancy \< 6 months; * Presence of any contraindication with regard to treatment with PH FDC SC as specified in the corresponding Summary of Product Characteristics (SmPCs) approved in Italy; * Concomitant participation in another interventional or non-interventional trial. * Patients with less than 6 remaining cycles of therapy with PH FDC SC to conclude pre-established oncological treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and percentage of patients with grade 3-4 adverse events (AEs), according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0). | From enrollment to the end of the study (about 24 months) |
Secondary
| Measure | Time frame |
|---|---|
| Other safety endpoints: number and percentage of patients with any AE, serious AEs, fatal AEs, AEs leading to withdrawal of study drug, adverse events of special interest (AESI, refer to Section 13.1.3 for the list); | From enrollment to the end of the study (about 24 months) |
| Patient's social cost evaluated by means of estimation of indirect costs (Loss of productivity for patients and caregiver) using a specific questionnaire administered at the Screening, after the third cycle of therapy and at the End of Treatment visit; | From enrollment to the end of the study (about 24 months) |
| Patient's HRQOL, evaluated by means of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) administered at the Screening, after the third cycle of therapy and at the End of Treatment visit. | From enrollment to the end of the study (about 24 months) |
Countries
Italy
Outcome results
None listed