A phase IIIb study to characterize the efficacy and safety of Adjuvant ribociclib plus endocrine therapy in a close to clinical practice patient population with HR positive HER2 negative early breast cancer (Adjuvant WIDER)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3,100
- 试验地点
- 10
- 主要终点
- The main question this trial is designed to answer is if early breast cancer participants receiving ribociclib in combination with hormonal therapy have the cancer coming back after 3 years using STEEP (Standardized Definition for Efficacy Endpoints in Adjuvant Breast Cancer Clinical Trials) by Investigators
研究概览
简要总结
Cancer is a well-known condition where abnormal cells in the body begin to grow and divide uncontrollably. Different stages of cancer are defined by the location of the cancerous cells and whether they have spread to other areas in the body. Patients with early breast cancer have minimal spread to other parts of the body. Although many patients may be declared disease-free after cancer treatment, early breast cancer patients still have a risk of the cancer coming back after the first diagnosis.
The purpose of this trial is to evaluate if the study drug, ribociclib, when added to the standard of care hormonal treatment, can help reduce the risk of breast cancer returning in these patients.
Ribociclib is a drug designed to lower the activity of certain proteins in the body that control when cells divide. Blocking these proteins slows down the rate at which abnormal cells divide to create new tumors in the body. This trial is designed to find out if ribociclib in combination with hormonal therapy in participants with early breast cancer can maintain early breast cancer participants’ disease free. The trial is also designed to learn more about the safety of ribociclib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Approximately 2800 participants will have breast cancer that is stage III, stage IIB or IIA meeting certain criteria, and approximately 300 participants will have high risk Stage I breast cancer.
- •To qualify to join the study, participants must have at least 3 years remaining of standard hormone therapy, which is the duration of treatment on study.
排除标准
- •Participants cannot be on any other anti-cancer therapy, be pregnant or breast feeding, or plan to become pregnant during the trial.
- •Participants must not have any uncontrolled medical condition, including heart conditions.
结局指标
主要结局
The main question this trial is designed to answer is if early breast cancer participants receiving ribociclib in combination with hormonal therapy have the cancer coming back after 3 years using STEEP (Standardized Definition for Efficacy Endpoints in Adjuvant Breast Cancer Clinical Trials) by Investigators
时间窗: Your Study Doctor will assess if there are any signs of tumor growth in the breast tissue or other parts of the body.
次要结局
- If ribociclib plus hormonal therapy is safe
- If and when participants cancer comes back including breast and or new cancer(Every 3 cycles starting from Cycle 1 Day 1 during the first 24 months)
- If and when participants breast cancer spreads to other parts of the body(Within 4 weeks after clinical suspicion of recurrence)
- How long does it take from start of treatment until the return of participants breast cancer if applicable(Every 3 cycles starting from Cycle 1 Day 1 during the first 24 months)
- How concentrated the ribociclib dose was(Once daily on days 1 to 21 of each 28-day cycle for 39 cycles from C1D1)
- If and when participants stop taking ribociclib(Continuous up to 30 days after last dose of study treatment)
- How many participants are still alive from the start to the end of the study.(Rate at which participants die until end of the study)
- How participants feel and manage daily life when taking ribociclib plus hormonal therapy and after until their cancer returns or until end of the study(Every 3 cycles from C1D1 during the first 24 months every 6 cycles thereafter until 12 months after confirmation of distant recurrence At EoT and every recurrence unless within 4 weeks of last PRO assessment)
研究者
Murugananthan K
Novartis Healthcare Private Limited