Cancer
Conditions
Sponsors
Hoffmann La Roche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Eastern Cooperative Oncology Group (ECOG) performance status 0-1 -Intact skin at planned site of subcutaneous (SC) injections -Left ventricular ejection fraction (LVEF) greater than or equal to (=)55% by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) -Negative human immunodeficiency virus (HIV) test at screening -Negative hepatitis B surface antigen (HBsAg) test at screening -Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb); Positive total HBcAb test followed by a negative (per local laboratory definition) hepatitis B virus (HBV) DNA test -Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening -For female participants of childbearing potential: agreement to remain abstinent or use contraception and agree to refrain from donating eggs during the treatment period and for 7 months after the final dose of the study treatment -For male participants: agreement to remain abstinent or use a condom, and agree to refrain from donating sperm during the treatment period and for 7 months after the final dose of study treatment
Exclusion criteria
Exclusion criteria: -Stage IV (metastatic) breast cancer -History of concurrent or previously treated non-breast malignancies, except for appropriately treated 1) non-melanoma skin cancer and/or 2) in situ carcinomas, including cervix, colon, and skin. A participant with previous invasive non-breast cancer is eligible provided he/she has been disease free for more than 5 years -Participants who are pregnant or breastfeeding or intending to become pregnant during the study or within 7 months after the final dose of study treatments -Treatment with investigational therapy within 28 days prior to initiation of study treatment -Active, unresolved infections at screening requiring treatment -Participants who may have had a recent episode of thromboembolism and are still trying to optimize the anticoagulation dose and/or have not normalized their International Normalized Ratio (INR)-Serious cardiac illness or medical conditions -History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias-Inadequate bone marrow function-Impaired liver function-Renal function with creatinine clearance 1.5x upper limit of normal (ULN) -Major surgical procedure unrelated to breast cancer within 28 days prior to study entry or anticipation of the need for major surgery during the course of study treatment -Current severe, uncontrolled systemic disease that may interfere with planned treatment -Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study -Known active liver disease, for example, active viral hepatitis infection, autoimmune hepatic disorders, or sclerosing cholangitis -Known hypersensitivity to any of the study drugs, excipients, and/or murine proteins or a history of severe allergic or immunological reactions, e.g., difficult to control asthma-Current chronic daily treatment with corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Preferred the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting, Question 1 of the Patient Preference Questionnaire [ Time Frame: Day 1 of Cycle 8 of adjuvant treatment (1 cycle is 3 weeks) ] | — |
Secondary
| Measure | Time frame |
|---|---|
| -Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1 of the Healthcare Professional Questionnaire (HCPQ) - Neoadjuvant Phase Drug Preparation Area [ Time Frame: Day 1 of each cycle from Cycle 1 to last cycle (Cycle 6 or 8) of neoadjuvant treatment (1 cycle is 3 weeks) ] -Percentage of Healthcare Professionals by Their Responses on Perception of Impact of PH FDC SC on Clinical Management and Clinical Efficiency, Question 2 of the HCPQ - Neoadjuvant Phase Drug Preparation Area [ Time Frame: Day 1 of last cycle (Cycle 6 or 8) of neoadjuvant treatment (1 cycle is 3 weeks) ] -Percentage of Healthcare Professionals by Their Responses on Perception of Time/Resource Use of Each Study Regimen, Questions 3 and 4 of the HCPQ - Neoadjuvant Phase Drug Preparation Area [ Time Frame: Day 1 of last cycle (Cycle 6 or 8) of neoadjuvant treatment (1 cycle is 3 weeks) ] -Duration of Treatment Administration Activities, According to Healthcare Professionals' Responses to Question 1 of the HCPQ - Neoadjuvant Phase Administering Treatment [ Time Frame: Day 1 of each cycle from Cycle 1 to last cycle (Cycle 6 or 8) of neoadjuvant treatment (1 cycle is 3 weeks) ] -Percentage of Healthcare Professionals by Their Responses on Perception of Impact of PH FDC SC on Clinical Management and Clinical Efficiency, Question 2 of the HCPQ - Neoadjuvant Phase Administering Treatment [ Time Frame: Day 1 of last cycle (Cycle 6 or 8) of neoadjuvant treatment (1 cycle is 3 weeks) ];-Percentage of Healthcare Professionals by Their Responses on Perception of Time/Resource Use and Convenience of Each Study Regimen, Questions 3 to 10 of the HCPQ - Neoadjuvant Phase Administering Treatment [ Time Frame: Day 1 of last cycle (Cycle 6 or 8) of neoadjuvant treatment (1 cycle is 3 weeks) ] -Percentage of Healthcare Professionals by Their Responses to Question 11 of the HCPQ - Neoadjuvant Phase Administering Treatment [ Time Frame: Day 1 of last cycle (Cycle 6 or 8) of | — |
Countries
Kenya
Contacts
Public ContactGladys Mills
CSM and Start Up Manager Area Africa CONAA
Outcome results
None listed