A study to see if the drug Lu-177 trastuzumab can be used to treat patinets with HER-2 positive cancer breast
Not Applicable
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2023/05/053068
- Lead Sponsor
- Ashok Kumar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients with HER2 positive carcinoma breast metastatic disease
-progressed on previous therapy with anti HER2 targeted agents or cardiotoxicity to trastuzumab
-tumor positive on low dose Lu-177 Trastuzumab scan
-Patients will be asked to undergo baseline evaluation and should have adequate organ function
Exclusion Criteria
-patient allergic to trastuzumab
-pregnant and lactating females
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) [ Time Frame: imaging at the end of 4 cycles] Using RECIST 1.1 criteria and evaluation of tumor avidity on Lu-177 low dose trastuzumab scanTimepoint: baseline and at 8 months
- Secondary Outcome Measures
Name Time Method Disease control rate (DCR): A point estimate and 2-sided 95% CI will be provided for the DCR, defined as the proportion of participants achieving a complete response (CR), partial response (PR), or stable disease (SD) (as assessed by the investigator per Response Evaluation Criteria in Solid Tumors [RECIST1.1]Timepoint: imaging will be done at the begining of each cycle;Duration of response (DOR):DOR will be plotted with cumulative incidence function curves (one curve for recurrence and one curve for non-relapse death). <br/ ><br>Timepoint: upto 12 months post therapy;Duration of stable diseaseTimepoint: upto 12 months post therapy;Incidence of adverse events (AEs):Timepoint: clinical follow up every 2 weeks for the first month after therapy and once a month after that;Progression-free survival:The estimated distribution of PFS will be plotted using a Kaplan Meier curve and reported with median survival and a 95% CITimepoint: followup upto 12 months post therapy