Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Lu-177 trastuzumab therapy: Lu-177 is a type of radioimmunotherapy where the Radiation emitting agent LU-177 is combined with the monocolnal antibody trastuzumab. Lu-177 trastuzumab con
Sponsors
Ashok Kumar
Nandini Pandit
Eligibility
Inclusion criteria
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
Exclusion criteria: -patient allergic to trastuzumab -pregnant and lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). 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 | — |
Countries
India
Contacts
Public ContactAshok Kumar
JIPMER, Puducherry
Outcome results
None listed