Clinical trial/study for Breast Cancer patient with HER2 positive
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2023/03/050491
- Lead Sponsor
- F HoffmannLa Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 346
Eastern Cooperative Oncology Group performance status 0 to 1
Intact skin at planned site of subcutaneous injections
LVEF greater than or equal to 55 percent by echocardiogram or multiple-gated acquisition scan
Negative HIV test and HBsAg at screening
Positive HBsAb test at screening, or negative HBsAb at screening accompanied by either of the following Negative total hepatitis B core antibody; Positive total HBcAb test followed by a negative hepatitis B virus DNA test
Negative hepatitis C virus 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
Female and male participants with stage II to IIIC early or locally advanced/inflammatory human epidermal growth factor receptor 2 positive HER2 positive breast cancer
Primary tumor more than 2 cm in diameter, or node positive disease
HER2 positive breast cancer confirmed by a local laboratory prior to study enrollment.
Agreement to undergo mastectomy or breast conserving surgery after neoadjuvant therapy, including the axillary nodes
Availability of formalin fixed, paraffine embedded tumor tissue block for local confirmation of HER2 and hormone receptor status following current ASCO or CAP guidelines
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 QuestionnaireTimepoint: Day 1 of Cycle 8 of adjuvant treatment.1 cycle is 3 weeks
- Secondary Outcome Measures
Name Time Method