A Phase II Randomized Controlled Trial Comparing Alternating Versus Sequential Dose-Dense AC and Taxane Chemotherapy in the Neoadjuvant Treatment of Triple-Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 1. Change in global quality of life (QoL) from baseline to the end of chemotherapy, measured using the EORTC QLQ-C30 questionnaire.
研究概览
简要总结
A single-center, two-arm, parallel-design, randomized controlled trial comparing an alternating versus standard sequential chemotherapy schedule of doxorubicin–cyclophosphamide (AC) and paclitaxel (T) in patients with early-stage triple-negative breast cancer (TNBC). The trial aims to assess whether the alternating schedule improves quality of life (QoL) and neuropathy outcomes compared to the standard sequential approach.
A total of 72 patients will be randomized in a 1:1 ratio (36 per arm) to receive either the standard sequential AC – T regimen or an alternating AC–T schedule. Treatment will be administered in a dose-dense format (every 2 weeks) with G-CSF support.
QoL will be assessed using validated questionnaires at three key time points: baseline (pre-treatment), post-cycle 4 (mid-chemotherapy), and post-cycle 8 (end of chemotherapy). Peripheral neuropathy will be evaluated through both patient-reported outcomes and nerve conduction studies (NCS). Toxicity will be assessed clinically after each cycle and graded using CTCAE v5.0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- ••Histologically confirmed triple negative breast cancer (ER negative PR negative HER2 negative) and Stage I to III.
- ••Planned for neoadjuvant chemotherapy with AC and not affordable for immunotherapy.
- ••ECOG performance status 0 to
- ••Adequate bone marrow, renal, hepatic and cardiac function.
- ••Written informed consent provided.
排除标准
- ••Prior chemotherapy or radiotherapy.
- ••Pre existing neuropathy assessed by nerve conduction study.
- ••Uncontrolled diabetes (HbA1c more than 8) •Active or uncontrolled infection or significant comorbidity interfering with protocol compliance.
- ••Pregnant or breastfeeding women.
结局指标
主要结局
1. Change in global quality of life (QoL) from baseline to the end of chemotherapy, measured using the EORTC QLQ-C30 questionnaire.
时间窗: 1. Change in global quality of life (QoL) from baseline to the end of chemotherapy, measured using the EORTC QLQ-C30 questionnaire.
次要结局
- Incidence & severity of peripheral neuropathy, assessed using(Patient-reported outcomes via the CIPN20 questionnaire estimated at baseline, after 6 weeks, & after 14 weeks.)
- Overall toxicity profile, assessed clinically at the end of each chemotherapy cycle and graded using CTCAE v5.0.
- Treatment completion rates, defined as the proportion of patients completing all 8 planned chemotherapy cycles without dose reductions or delays.
- Pathological complete response (pCR) rates, defined as the absence of invasive cancer in the breast and axillary nodes (ypT0/is, ypN0) at the time of definitive surgery, compared between the two arms.
研究者
Dr Atul Batra
All India Institute of Medical Science, New Delhi