Health Condition 1: 8- Other Procedures
Conditions
Interventions
Intervention1: Trastuzumab Deruxtecan (T-DXd): T-DXd comes as a 100mg vial.
The 100 mg vial is to be reconstituted slowly with 5 mL of Sterile Water for Injection, USP into each vial to obtain a fina
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients (above 18 years age) with unresectable/metastatic ER-positive and HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. 2. Refractory to endocrine therapy. 3. Prior treatment with 1 2 chemotherapy lines in the metastatic setting. 4. No prior anti-HER2 therapy. 5. ECOG performance status 0 1
Exclusion criteria
Exclusion criteria: 1. Patients with triple-negative breast cancer (TNBC) will be excluded. 2. Has a medical history of myocardial infarction within 6 months before enrollment. 3. Has a history of symptomatic congestive heart failure. 4. Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening. 5. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. However, subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluating Progression-Free Survival (PFS) with a flat 100 mg dose of Trastuzumab Deruxtecan (T-DXd).Timepoint: For the enrolled participants, progression-free survival will be assessed from the time of enrollment in the study till the patient has confirmed disease progression with radiological/lab investigation evidence. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess overall response rate (ORR), disease control rate (DCR), overall survival (OS), and quality of life (QoL). Analyze the incidence and severity of adverse events. Determine the cost-effectiveness of the treatment. Timepoint: For the enrolled participants, the overall response rate, disease control rate, overall survival rate, and quality of life will be assessed from the time of enrollment in the study till the patient has confirmed disease progression with radiological/lab investigation evidence. | — |
Countries
India
Contacts
Public ContactPrabhat Bhargava
Tata Memorial Centre
Outcome results
None listed