CTRI/2023/04/051319
Recruiting
Phase 4
A Prospective, Multicenter, Non-Interventional, Observational, Real-World Study to Evaluate the Safety, Adherence to Therapy, and Effectiveness of a T-DM1 Antibody-Drug Conjugate Biosimilar in Indian Patients with HER2-Positive Early Breast Cancer
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Sponsor
- Zydus Lifesciences Limited
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Female with age \=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: T1–4, N0–3, 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 \=6 months
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Unknown
Not Applicable
An observational study to understand usage and effect of daclatasvir use with sofosbuvir for the treatment of adults with chronic hepatitis C infectionsCTRI/2017/07/009056Torrent Pharmaceuticals Ltd54
Not yet recruiting
Not Applicable
A study to compare the usage and safety of Teneligliptin versus Glimepiride in diabetic patients being treated with MetformiCTRI/2017/08/009262Torrent Pharmaceuticals Ltd
Recruiting
Not Applicable
A Observational Study to Understand Usage and Effectiveness of Teneligliptin in Indian Patients with Type 2 Diabetes MellitusHealth Condition 1: null- Type 2 Diabetes MellitusCTRI/2018/08/015457Torrent Pharmaceuticals Ltd
Unknown
Not Applicable
An observational study to understand usage and effect of combination of ledipasvir and sofosbuvir in adult patients with Hepatitis C InfectioHealth Condition 1: null- Chronic Hepatitis CCTRI/2016/11/007468Torrent Pharmaceuticals Ltd88
Recruiting
Not Applicable
An observational study to understand usage and effect of Azilsartan in Indian patients with high blood pressureCTRI/2018/05/014303Torrent Pharmaceuticals Ltd