CTRI/2023/04/051319招募中Unknown
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
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 10
- 主要终点
- To evaluate the safety of UJVIRA in HER2-positive EBC patients
研究概览
简要总结
This is aProspective, Multicenter, Non-Interventional, Real-World Study to Evaluate theSafety, Adherence to Therapy, and Effectiveness of a T-DM1 Antibody-DrugConjugate Biosimilar (Zydus Lifesciences Ltd) patients with HER2-Positive EarlyBreast Cancer.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female with age ≥18 years
- •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
- •Histologically confirmed invasive breast carcinoma
- •Clinical stage at presentation: T1–4, N0–3, M0 (Note: Patients with T1a/bN0 tumors will not be eligible)
- •Completion of preoperative systemic treatment consisting of at least 4 cycles, including at least 9 weeks of trastuzumab
- •Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes
- •Pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy
- •Known hormone receptor status (either ER and/or PR of the primary tumor)
- •Life expectancy ≥6 months
- •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.
排除标准
- •Stage IV (metastatic) breast cancer
- •History of any prior (ipsi- or contralateral)
- •breast cancer except lobular carcinoma in situ (LCIS)
- •Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery
- •Progressive disease (PD) during preoperative therapy
- •Treatment with any anti-cancer investigational drug within 28 days before commencing study treatment
- •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
- •Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons
- •Prior treatment with trastuzumab emtansine
- •For female patients, current pregnancy and/or lactation
- •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
- •History of intolerance, including grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins.
结局指标
主要结局
To evaluate the safety of UJVIRA in HER2-positive EBC patients
时间窗: Follow up at 1 year and at 2 year
次要结局
- • To evaluate adherence to UJVIRA therapy(• To evaluate the effectiveness of UJVIRA in terms of invasive disease-free survival (IDFS) in HER2-positive EBC patients)
研究者
研究点 (10)
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