To Evaluate The Safety and Efficacy of Pertuzumab and Trastuzumab (Phesgo)in Breast Cancer Patients
Phase 4
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2023/02/050070
- Lead Sponsor
- Roche Products India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Signed Informed Consent Form
Women of age =18 years at time of signing Informed Consent Form
HER2+ breast cancer status confirmed by local laboratory before study enrollment
Hormone receptor status of the primary tumor determined by local assessment
Exclusion Criteria
Treatment with investigational therapy within 4 weeks of enrollment
Serious cardiac illness or medical conditions
History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
Inadequate bone marrow function
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Incidence and severity of adverse events (AEs), with severity determined according to the NCI CTCAE v5.0 grading scale. <br/ ><br>a. Phesgo in combination with chemotherapy <br/ ><br>b. Phesgo without concurrent chemotherapy <br/ ><br>2. Incidence and severity of serious adverse events (SAEs), with severity determined according to the NCI CTCAE v5.0 grading scale <br/ ><br>3. Incidence and severity of adverse events of special interest (AESIs)Timepoint: The primary analysis will be performed on safety analysis set that will include all enrolled patients who receive at least one dose of Phesgo or P plus H IV.
- Secondary Outcome Measures
Name Time Method 1 For Cohort 1 only: to evaluate total pathological complete response (tpCR) <br/ ><br>2 For Cohort 3 only: to evaluate Overall Response Rate (ORR) <br/ ><br>3 To assess healthcare professionals (HCP) perception on time/resource for using SC versus IV formulationTimepoint: At baseline and at end of the treatment period.