PACTR202212829625733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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,542
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
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •--Histologically or cytologically confirmed and documented human epidermal growth factor receptor 2 (HER2)-positive/estrogen receptor (ER)-positive adenocarcinoma of the breast with metastatic or locally-advanced disease not amenable to curative resection
- •-At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- •-Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of =6 months
- •-Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- •-Left ventricular ejection fraction (LVEF) of at least (=)50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
- •-Adequate hematologic and end-organ function
- •-For women of childbearing potential: Participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs, during the treatment period and for 7 months after the final dose of Phesgo
- •-For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm, during the treatment period and for 7 months after the final dose of Phesgo to avoid exposing the embryo
- •Maintenance Phase Inclusion Criteria
- •-Complete a minimum of four cycles of induction therapy
- •-Achieve a minimum of stable disease (SD) (or Non-complete response [CR]/Non-progressive disease [PD] for participants with non-measurable disease) (i.e., did not experience PD) according to RECIST v1.1 at the last tumor assessment during the induction therapy phase
- •-LVEF of =50% 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 (MBC) or advanced breast cancer (ABC) 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 (SERD)
- •Previous treatment with approved or investigative anti-HER2 agents in any breast cancer treatment setting, except Phesgo (or trastuzumab SC with pertuzumab IV, or pertuzumab and trastuzumab IV), 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
- •Non-resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) Grade 1 or better
- •History of persistent Grade =2 (NCI-CTC, Version 5.0) hematological toxicity resulting from previous adjuvant or neo-adjuvant therapy
- •History of exposure to the following cumulative doses of anthracyclines; Doxorubicin >360 mg/m2; Liposomal doxorubicin >500 mg/m2; Epirubucin >720 mg/m2; Mitoxantrone >120 mg/m2; Idarubicin >90 mg/m2.
- •Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease
- •Dyspnea at rest due to complications of advanced malignancy, or other disease requiring continuous oxygen therapy
- •Pregnant or breastfeeding, or intending to become pregnant during the study or within 7 months after the final dose of Phesgo
- •Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of induction therapy
- •Treated with investigational therapy within 28 days prior to initiation of induction therapy
- •Treated with localized palliative radiotherapy within 14 days prior to initiation of induction
研究者
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