ChiCTR2100043105
Active, not recruiting
Early Phase 1
TPC+马来酸吡咯替尼联合曲妥珠单抗治疗 HER2 阳性乳腺癌新辅助含 HP 方案疗效不佳的单臂、多中心临床探索研究
广州中医药大学第二附属医院8 sites in 1 countryStarted: March 1, 2021Last updated:
Overview
- Phase
- Early Phase 1
- Status
- Active, not recruiting
- Sponsor
- 广州中医药大学第二附属医院
- Locations
- 8
- Primary Endpoint
- 病理完全缓解率
Overview
Brief Summary
探索 HER2 阳性新辅助双靶含曲妥珠单抗及帕妥珠单抗治疗过程中评估为 SD（评估为增大 0-20%）或 PD 的患者，更改为 TPC 联合马来酸吡咯替尼及曲妥珠单抗治疗的疗效和安全性。
Study Design
- Study Type
- 干预性研究
- Primary Purpose
- 单臂
- Masking
- N/a
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •病理学检查证实的 HER2 阳性 Stage II（cT3N0M0）-III 期乳腺癌患者；
- •女性，年龄≥18 岁，且≤70 岁；
- •ECOG 评分为 0 分或 1 分，并评估可耐受后续治疗；
- •既往接受新辅助方案含曲妥珠单抗联合帕妥珠单抗治疗至少 2 周期，且根据 RECIST 1.1 评估为 SD（评估为增大 0-20%）或 PD 患者；
- •自愿加入本研究，签署知情同意，有良好的依从性并愿意配合随访。
Exclusion Criteria
- •合并有严重的心脑血管或精神相关疾病的患者；
- •妊娠期、哺乳期女性患者，有生育能力且基线妊娠试验阳性的女性患者或在整个试验期间不愿意采取有效避孕措施的育龄女性患者；
- •无法吞咽、慢性腹泻和肠梗阻，存在影响药物服用和吸收的多种因素；
- •入组前 4 周使用过其他临床试验的研究药物；
- •同时接受其他任何瘤肿的任何抗肿瘤治疗者；
- •双侧乳腺癌，炎性乳腺癌患者；
- •根据研究者的判断，有严重的危害患者安全、或影响患者完成研究的伴随疾病（包括但不限于药物无法控制的严重高血压、严重的糖尿病等）；
- •研究者认为患者不适合参加本研究的其他任何情况。
Arms & Interventions
试验组
Outcomes
Primary Outcomes
病理完全缓解率
Secondary Outcomes
- 客观缓解率
- 无病生存期
- 全基因检测
Investigators
Study Sites (8)
Loading locations...
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