A Study of SC Administration of Trastuzumab (Herceptin) by SID at Home in HER2-Positive EBC Participants
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant)
- Hormonal therapy will be allowed as per institutional guidelines
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- ...
- No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant)
- Hormonal therapy will be allowed as per institutional guidelines
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Completion of surgery and chemotherapy (if applicable)
- HER2-positive disease
- Prior use of anti-HER2 therapy will be allowed
- Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
- Left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 50 percent (%)
- Use of concurrent radiotherapy will be permitted
Exclusion Criteria
- Women of childbearing potential and male participants with female partners of childbearing potential who are unable or unwilling to use adequate contraceptive methods during study treatment
- Participants with other concurrent serious diseases that might interfere with planned treatment, including severe pulmonary conditions/illness
- Inadequate hepatic or renal function
- ...
- Women of childbearing potential and male participants with female partners of childbearing potential who are unable or unwilling to use adequate contraceptive methods during study treatment
- Participants with other concurrent serious diseases that might interfere with planned treatment, including severe pulmonary conditions/illness
- Inadequate hepatic or renal function
- Known hypersensitivity to trastuzumab, murine proteins, to any excipients of Herceptin, including hyaluronidase, or the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma
- Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
- Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure, high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), poorly controlled hypertension
- Pregnant or lactating women
- History of other malignancy, except for participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively treated malignancies who have been disease-free for the last 5 years
- Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
Summary
- Conditions
- Breast Cancer
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Inclusion Criteria
- No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant)
- Hormonal therapy will be allowed as per institutional guidelines
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- ...
- No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant)
- Hormonal therapy will be allowed as per institutional guidelines
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Completion of surgery and chemotherapy (if applicable)
- HER2-positive disease
- Prior use of anti-HER2 therapy will be allowed
- Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
- Left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 50 percent (%)
- Use of concurrent radiotherapy will be permitted
Exclusion Criteria
- Women of childbearing potential and male participants with female partners of childbearing potential who are unable or unwilling to use adequate contraceptive methods during study treatment
- Participants with other concurrent serious diseases that might interfere with planned treatment, including severe pulmonary conditions/illness
- Inadequate hepatic or renal function
- ...
- Women of childbearing potential and male participants with female partners of childbearing potential who are unable or unwilling to use adequate contraceptive methods during study treatment
- Participants with other concurrent serious diseases that might interfere with planned treatment, including severe pulmonary conditions/illness
- Inadequate hepatic or renal function
- Known hypersensitivity to trastuzumab, murine proteins, to any excipients of Herceptin, including hyaluronidase, or the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma
- Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
- Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure, high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), poorly controlled hypertension
- Pregnant or lactating women
- History of other malignancy, except for participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively treated malignancies who have been disease-free for the last 5 years
- Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
Tracking Information
- NCT #
- NCT02040935
- Collaborators
- Not Provided
- Investigators
- Study Director: Clinical Trials Hoffmann-La Roche