Real world outcomes with Ribociclib in Indian patients with HR Positive, HER2 Negative Advanced Breast Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 20
- 主要终点
- 1. To evaluate median real-world progression free survival (rwPFS) in Indian women with HR+ve, HER2-ve aBC receiving at least one dose of ribociclib by line of therapy, i.e., first line, second line, and subsequent lines
研究概览
简要总结
| Breast cancer (BC) is the most common cancer (25% of all cancers) and the major cause of cancer mortality among women. The two prime strategies for the management of BC are locoregional treatment and systemic therapy based on the histological and molecular characteristics of BC. |
Immunohistochemistry (IHC) of BC is important for determining the treatment and predicting the prognosis. IHC characterization depends on the expression of biomarkers such as estrogen receptor (ER), progesterone receptor (PgR), and human epidermal growth factor receptor 2 (HER2).
Approximately 70% of BC in women >50 years of age express ER and/or PgR, but not HER2, and are termed hormone receptor-positive (HR+ve) and HER2-ve BC. Metastatic BC patients with HR+ve and HER2 -ve BC have better survival rates than other sub-categories of advanced BC (aBC)(Onitilo et al., 2009).
Endocrine therapy (ET) targeting the ER directly is the core treatment modality. However, it has been reported that 15-20% of tumors are intrinsically resistant to ET. Another 30-40% acquire resistance to ET over the years, resulting in relapse and metastasis of cancer that eventually leads to death.
Ribociclib, a selective CDK4/6 inhibitor, is approved in India for the first-line treatment of women with HR+ve and HER2-ve locally advanced or metastatic BC in combination with an AI or fulvestrant as initial endocrine-based therapy or in women who have received prior ET (CDSCO).
The clinical efficacy and safety of ribociclib has been well established by various clinical trials like MONALEESA-2 (Hortobagyi, 2016), MONALEESA-3 (Slamon, 2018) and MONALEESA-7 (Tripathy, 2018). However, the discussion is still ongoing on whether the use of CDK4/6 inhibitors as second-line or in subsequent lines of therapy provides an equal PFS compared to first-line usage.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Greater than equal to 18 years old women
- •HR+ve and HER2-ve aBC diagnosis
- •Received ribociclib plus ET in line with the approved indication with at least one follow-up visit after diagnosis, or death due to any cause.
排除标准
- •Any patient with prior/current enrollment in an interventional clinical trial for aBC/metastatic BC
- •Patient who has received another CDK4/6 inhibitor in any setting.
结局指标
主要结局
1. To evaluate median real-world progression free survival (rwPFS) in Indian women with HR+ve, HER2-ve aBC receiving at least one dose of ribociclib by line of therapy, i.e., first line, second line, and subsequent lines
时间窗: 1. From Baseline to every follow-up visit
次要结局
- 1. To evaluate median real- world progression-free survival (rwPFS) in Indian women with HR positive, HER2 negative aBC by line of therapy receiving ribociclib with at least 6 months of follow-up(2. To evaluate safety and tolerability of ribociclib in Indian women with HR positive, HER2 negative aBC by the line of therapy receiving at least one dose of ribociclib)