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
- 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 (%)
- ...
- 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 (%)
- No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant)
- HER2-positive disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Completion of surgery and chemotherapy (if applicable)
- Hormonal therapy will be allowed as per institutional guidelines
- Use of concurrent radiotherapy will be permitted
Exclusion Criteria
- 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
- Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
- Participants with other concurrent serious diseases that might interfere with planned treatment, including severe pulmonary conditions/illness
- ...
- 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
- Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
- Participants with other concurrent serious diseases that might interfere with planned treatment, including severe pulmonary conditions/illness
- 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
- 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
- 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
- Pregnant or lactating women
- Inadequate hepatic or renal function
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
- 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 (%)
- ...
- 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 (%)
- No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant)
- HER2-positive disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Completion of surgery and chemotherapy (if applicable)
- Hormonal therapy will be allowed as per institutional guidelines
- Use of concurrent radiotherapy will be permitted
Exclusion Criteria
- 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
- Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
- Participants with other concurrent serious diseases that might interfere with planned treatment, including severe pulmonary conditions/illness
- ...
- 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
- Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
- Participants with other concurrent serious diseases that might interfere with planned treatment, including severe pulmonary conditions/illness
- 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
- 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
- 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
- Pregnant or lactating women
- Inadequate hepatic or renal function
Tracking Information
- NCT #
- NCT02040935
- Collaborators
- Not Provided
- Investigators
- Study Director: Clinical Trials Hoffmann-La Roche