Phase 4 Study to Assess the Safety of Trastuzumab Deruxtecan, in Indian Patients
A PROSPECTIVE, MULTI-CENTER, PHASE 4, SINGLE ARM STUDY TO ASSESS THE SAFETY OF TRASTUZUMAB DERUXTECAN, AN ANTI-HER2-ANTIBODY DRUG CONJUGATE IN INDIAN PATIENTS WITH UNRESECTABLE OR METASTATIC HER2-POSITIVE BREAST CANCER WHO HAVE RECEIVED A PRIOR ANTI-HER2-BASED REGIMEN
| Condition(s) | BREAST CANCER |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | A PROSPECTIVE, MULTI-CENTER, PHASE 4, SINGLE ARM STUDY TO ASSESS THE SAFETY OF TRASTUZUMAB DERUXTECAN, AN ANTI-HER2-ANTIBODY DRUG CONJUGATE IN INDIAN PATIENTS WITH UNRESECTABLE OR METASTATIC HER2-POSITIVE BREAST CANCER WHO HAVE RECEIVED A PRIOR ANTI-HER2-BASED REGIMEN |
| Who can participate | Inclusion Criteria: 1 Participant must be \>18 years of age inclusive, at the time of signing the informed consent. 2 Patients who are willing and capable of giving signed informed consent as described in Appendix A, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 3 Participants with pathologically documented breast cancer that: * is unresectable or metastatic * HER2-positive expression (IHC 3+ or IHC 2+ with ISH positive) as confirmed by laboratory assessment within last 1 year of study enrolment. * was previously treated with an anti HER-2 based regimen 4 Adequate bone marrow function, within 14 d before enrolment, defined as: a. Absolute neutrophil count ≥ 1.5 × 109/L (granulocyte colony-stimulating factor |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | AstraZeneca |
| Locations | Bangalore, India; Delhi, India; Kochi, India; Mumbai, India; Pune, India; Varanasi, India |
| Start date | 2025-01-02 |
| NCT ID | NCT06429761 |
| Official listing | https://clinicaltrials.gov/study/NCT06429761 |