CTRI/2023/08/056489招募中3 期
A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF GIREDESTRANT IN COMBINATION WITH PHESGO VERSUS PHESGO AFTER INDUCTION THERAPY WITH PHESGO TAXANE IN PATIENTS WITH PREVIOUSLY UNTREATED HER2-POSITIVE, ESTROGEN RECEPTOR-POSITIVE LOCALLY-ADVANCED OR METASTATIC BREAST CANCER - heredERA
F HoffmannLa Roche Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Histologically or cytologically confirmed and documented human epidermal growth factor receptor 2 positive/estrogen receptor positive adenocarcinoma of the breast with metastatic or locally-advanced disease not amenable to curative resection.
- •Complete a minimum of four cycles of induction therapy
- •Achieve a minimum of stable disease according to RECIST v1.1 at the last tumor assessment during the induction therapy phase
- •LVEF of more than equal to 50 percent at the last assessment during the induction therapy phase
排除标准
- •Previous systemic non-hormonal anti-cancer therapy in the metastatic breast cancer or advanced breast cancer setting. Note: Up to one line of single-agent endocrine therapy given in the metastatic or locally advanced setting will be allowed.
- •Prior treatment with a selective estrogen receptor degrader
- •Previous treatment with approved or investigative anti HER2 agents in any breast cancer treatment setting, except Phesgo, ado-trastuzumab emtansine, lapatinib, and neratinib in the neoadjuvant or adjuvant setting
- •Disease progression within 6 months of receiving trastuzumab, with or without pertuzumab, or ado-trastuzumab emtansine in the adjuvant setting
研究者
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