Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
None listed
Sponsors
Zydus Lifesciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female with age ââ?°Â¥18 years 2. HER2-positive breast cancer: Positivity will be based on pretreatment biopsy and defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH), prospectively confirmed by a hospital/laboratory before study enrollment 3. Histologically confirmed invasive breast carcinoma 4. Clinical stage at presentation: T1ââ?¬â??4, N0ââ?¬â??3, M0 (Note: Patients with T1a/bN0 tumors will not be eligible) 5. Completion of preoperative systemic treatment consisting of at least 4 cycles, including at least 9 weeks of trastuzumab 6. Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes 7. Pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy 8. Known hormone receptor status (either ER and/or PR of the primary tumor) 9. Patients who are willing to give informed consent 10. Life expectancy ââ?°Â¥6 months 11. Confirmed non-pregnant status for premenopausal women including women who have had a tubal ligation and for women less than 12 months after the onset of menopause
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic) breast cancer 2. History of any prior (ipsi- or contralateral) 3. breast cancer except lobular carcinoma in situ (LCIS) 4. Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery 5. Progressive disease (PD) during preoperative therapy 6. Treatment with any anti-cancer investigational drug within 28 days before commencing study treatment 7. History of other malignancy within the last 5 years except for appropriately treated carcinoma in situ (CIS) of the cervix, non-melanoma skin carcinoma, stage I uterine cancer, or other non-breast malignancies with an outcome similar to those mentioned above 8. Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons 9. Prior treatment with trastuzumab emtansine 10. For female patients, current pregnancy and/or lactation 11. Major surgical procedure unrelated to breast cancer or significant traumatic injury within approximately 28 days before enrollment or anticipation of the need for major surgery during the course of study treatment 12. History of intolerance, including grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of UJVIRA in HER2-positive EBC patients Timepoint: Follow up at 1 year and at 2 year | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ To evaluate adherence to UJVIRA therapy ââ?¬Â¢ To evaluate the effectiveness of UJVIRA in terms of invasive disease-free survival (IDFS) in HER2-positive EBC patients Timepoint: Follow up at 1 year and at 2 year | — |
Countries
India
Contacts
Public ContactDr Vipulkumar Thummar
Zydus Lifesciences Limited
Outcome results
None listed