EUCTR2021-000398-10-ES进行中（未招募）1 期
A randomized, multicenter, double-blind, Phase 3 study of amcenestrant (SAR439859) versus tamoxifen for the treatment of patients with hormone receptor-positive, human epidermal growth factor 2-negative or positive, stage IIB-III breast cancer who have discontinued adjuvant aromatase inhibitor therapy due to treatment-related toxicity - AMEERA-6
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 4,670
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Adult participants with histologically confirmed diagnosis of adenocarcinoma of the breast with documentation of hormone receptor-positive status, irrespective of human epidermal growth factor 2 (HER2) status.
- •NOTE: Participants with HER2-positive breast cancer are eligible only if they have completed their adjuvant anti-HER2 treatment and chemotherapy.
- •- With Stage IIB or Stage III, early invasive breast cancer at diagnosis who have undergone breast surgery for the current malignancy.
- •-Who have received prior aromatase inhibitors (AIs) (letrozole, anastrozole or exemestane or any sequence thereof) for at least 6 months and discontinued within 30 months from the initiation of the first AI administration due to AI treatment-related toxicity.
- •- Absence of advanced/metastatic disease.
- •- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
- •- Capable of giving signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3970
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 700
排除标准
- •- Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of amcenestrant and/or tamoxifen. Participants unable to swallow normally and to take tablet and capsules. Predictable poor compliance to oral treatment. Active inflammatory bowel disease or chronic diarrhea, active hepatitis A/B/C, hepatic cirrhosis, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection or banding procedures.
- •- Prior breast cancer for which they received an AI.
- •- Any other solid tumor or lymphoma diagnosis is not allowed except if the participant has been free from disease for > or =5 years.
- •- Pregnant or nursing women, or women of child-bearing potential without a negative pregnancy test prior to randomization.
- •- Participants with unrecovered acute toxic effects of prior AI therapy or surgical procedures.
- •- Uncontrolled intercurrent illness, including psychiatric conditions that would limit compliance with study requirements.
- •- Treatment with any another SERD, tamoxifen or toremifene are not allowed as prior adjuvant therapy but could have been used as neoadjuvant therapy for a total duration of 3 months. Participants who were treated with a SERD, tamoxifen or toremifene in the neoadjuvant setting and who experienced disease progression are not allowed.
- •- Participant is receiving concurrent HER2 directed therapy. Appropriate wash out between the last dose of HER2 directed therapy and randomization should be at least 4 weeks.
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